Abstract
Following the expiration of the adalimumab originator patent, there has been a rapid increase in the availability and uptake of adalimumab biosimilars. While chemically and clinically similar in effects, there are substantial non-pharmacological differences in these products. This global review compares the originator versus currently available adalimumab biosimilars, focusing on variations in formulations and patient support systems across different countries. The goal is to provide prescribers with guidance on selecting the most appropriate products. Data on adalimumab biosimilars were collected from global medication registries and Product Information documents, supplemented by direct inquiries to pharmaceutical companies, with data collection completed in September 2024. Experts from nine countries assessed the local patient support system and collaborated to illustrate the diversity of adalimumab. Including the originator, there are 29 adalimumab products available globally. We highlighted products with favorable characteristics, including delivery device, concentration, citrate content, the range of dosages, latex content, and shelf life. Patient support services helped to differentiate these products further, to capture market share. Among the reviewed countries, Australia, the United States, and Canada offered the most comprehensive patient support systems, including injection training, reminders, as well as nursing and other patient support services. This review highlights the global diversity of adalimumab products, emphasizing key usability factors, such as formulation, dosing flexibility, shelf life, and patient support. A comparative table is provided to aid clinicians in selecting the most appropriate option based on individual patient needs.
Keywords: adalimumab, biological agent, biosimilars, inflammatory bowel disease, patient support
Plain language summary
Study comparing adalimumab products and patient support in different countries
Why was the study done? After the original adalimumab drug lost its exclusive rights, many similar products (biosimilars) became available quickly. Although these products work in similar ways, they differ in important non-medical aspects. This review looks at these differences in adalimumab products and their patient support systems in various countries, aiming to help doctors choose the best options for their patients. What did the researchers do? We collected information about the original adalimumab and its biosimilars from global medication registries, drug manufacturers, and local experts across nine countries. What did the researchers find? There are 29 adalimumab products available worldwide, including the original. We identified several features that enhance a product’s appeal, such as specific delivery methods, concentration, ingredients, dosage options, and shelf life. Patient support services also differentiate these products, with variations across countries. Our review found that Australia and Canada provide the best support, including injection training and reminders. What do the findings mean? Adalimumab biosimilars have various strengths and weaknesses, and no single product is perfect for every patient. Therefore, it’s important to choose a product that fits each patient’s individual needs and healthcare situation.
Introduction
Adalimumab is a fully human monoclonal antibody targeting tumor necrosis factor-alpha (TNF-α), a crucial cytokine in immune-mediated conditions. By inhibiting TNF-α’s interaction with cell surface receptors, it effectively reduces immune and inflammatory responses in various autoimmune or immune dysregulation diseases. 1 Humira®, the original adalimumab formulation manufactured by AbbVie (North Chicago, IL, USA), received US Food and Drug Administration (FDA) approval for rheumatoid arthritis in 2002. It subsequently gained FDA approvals for Crohn’s disease in 2007 and ulcerative colitis in 2012. Other indications across different jurisdictions to date include juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, chronic plaque psoriasis, non-infectious uveitis, and hidradenitis suppurativa. 2
Biological therapies are costly. In 2018, the global market for TNF-α inhibitors, including adalimumab, infliximab, etanercept, certolizumab pegol, and golimumab, was worth US$40 billion annually, with Humira® accounting for half of these sales. 3 Biosimilars are highly similar versions of the original reference brand of a biological medicine that demonstrate comparable safety and efficacy in treating the same diseases. One major benefit is the reduction in expenditures for biological therapies through increased market competition. 4 This is exemplified by the introduction of biosimilars of etanercept and infliximab, resulting in notable price reductions of the originators. 5 The adalimumab biosimilars market is evolving, particularly with the gradual expiration of Humira®’s patents worldwide. In 2014, the Indian company Cadila (now known as Zydus Lifesciences Limited, Ahmedabad, India) launched Exemptia, the world’s first adalimumab biosimilar, in the Indian market. 6 This milestone was facilitated by the Indian Patent Act passed in 1970, where product patents are not recognized in India. 7 Subsequently, product-specific patent protection for Humira® ended in most European Union countries and Australia in 2018 and in the United States in 2023. 8
To date, there are over 20 adalimumab biosimilar products available worldwide. With the rapid expansion of the biosimilar market, clinicians and patients often encounter difficulties in staying updated on the plethora of new products and choosing between different biosimilar options. Formulations and patient support systems vary among products and countries, with some formulations offering unique benefits such as improved routes of administration, latex- and citrate-free formulations, and different volumes and rates of administration. This study seeks to conduct a comprehensive global review of both originator and biosimilar adalimumab, emphasizing formulation disparities and patient support systems across different countries and products.
Methods
We collected global adalimumab biosimilar data from medication registries, including the FDA in the United States, the European Medicines Agency (EMA) in European Union countries, Health Canada, the Medicines and Healthcare products Regulatory Agency in the United Kingdom, the Therapeutic Goods Administration in Australia, the Pharmacy and Poisons Board in Hong Kong, Health Sciences Authority in Singapore and the Central Drugs Standard Control Organization in India. We adopted the EMA’s definition of biosimilars—biological medicines that are highly similar to an already approved reference product and meet the same standards of pharmaceutical quality, safety, and efficacy as all biological medicines. 9 The search was completed in October 2023. Product details—including injection devices, dosages, formulations, and patient support programs—were obtained from official Product Information documents and supplemented with additional data gathered through direct inquiries to pharmaceutical companies to address any missing information. Detailed information is presented in Tables 2 and 3. Our communication with pharmaceutical companies occurred between November 2023 and September 2024, utilizing the contact details provided on their official websites. In instances where no response was received after the initial contact, a follow-up attempt was made 4 weeks later. A contact attempt was deemed unsuccessful only if no response was received after this second attempt. Figure 1 summarizes this research process.
Table 2.
Product details of currently listed biosimilars and reference adalimumab.
| Trade names | Humira | Amgevita Amjevita Adalimumab-Daiichi Sankyo |
Hadlima Adalloce |
Hyrimoz Halimatoz Hefiya |
Idacio | Yuflyma Adalimumab-CTNK |
Abrilada Amsparity Xilbrilada |
Hulio Adalimumab-FKB |
Exemptia | Xelenka Adalimumab-MA |
Hukyndra Adalicip Ciptunec Plamumab Cipleumab Simlandi |
Imraldi | Cyltezo | Yusimry |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AIP | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Dose | 40 mg/0.4 mL 80 mg/0.8 mL |
40 mg/0.8 mL | 40 mg/0.8 mL | 40 mg/0.8 mL 40 mg/0.4 mL |
40 mg/0.8 mL | 40 mg/0.4 mL | 40 mg/0.8 mL | 40 mg/0.8 mL | 40 mg/0.8 mL 20 mg/0.4 mL |
40 mg/0.4 mL | 40 mg/0.4 mL 80 mg/0.8 mL |
40 mg/0.8 mL 40 mg/0.4 mL |
40 mg/0.8 mL | 40 mg/0.8 mL |
| Needle safety | ✓ Retraction |
✓ Retraction |
✓ Needle cover |
✓ Retraction |
✓ Retraction |
✓ Retraction |
✓ Retraction |
✓ Retraction |
✓ Retraction |
✓ Retraction |
? | ✓ Retraction |
✓ Retraction |
✓ Retraction |
| Needle Gauge | 29G | 29G | 29G | 29G | 29G | 29G | 29G | 29G | 29G | 29G | 29G | 29G | 29G | 29G |
| Device shape | Round | Round | Rectangular | Triangular | Round | Square shape with rounded corners | Round | Round | Round | Rectangular | Rectangular | Round | Rectangular | Rectangular |
| Sound with delivery | ✓ 2 clicks (start and stop) |
✓ Click at the end |
✓ 2 clicks (start and stop) |
✓ 2 clicks (start and stop) |
✓ Click at start |
✓ 2 clicks (start and stop) |
✓ 2 clicks (start and stop) |
✓ 2 clicks (start and stop) |
✓ Click at the end |
✓ Click at start |
✓ 2 clicks (start and stop) |
✓ 2 clicks (start and stop) |
✓ Click at start |
✓ 2 clicks (start and stop) |
| Visual with delivery | ✓ Yellow bar |
✓ Yellow bar |
✓ Yellow bar |
✓ Green bar |
✓ Spring |
✓ Blue bar |
✓ Orange bar |
✓ Orange bar |
✓ Spring |
✓ Yellow bar |
✓ Yellow bar |
✓ Yellow bar |
✓ Spring |
✓ Orange bar |
| Injection technique | 1. Cap off 2. Press onto skin 3. Press the button |
1. Cap off 2. Press onto skin 3. Press the button |
1. Cap off 2. Press onto skin |
1. Cap off 2. Press onto skin |
1. Cap off 2. Press onto skin 3. Press the button |
1. Cap off 2. Press onto skin |
1. Cap off 2. Press onto skin 3. Press the button |
1. Cap off 2. Press onto skin |
1. Cap off 2. Press onto skin 3. Press the button |
1. Cap off 2. Press onto skin |
1. Cap off 2. Press onto skin |
1. Cap off 2. Press onto skin |
1. Cap off 2. Press onto skin 3. Press the button |
1. Cap off 2. Press onto skin |
| PFS | ✓ | ✓ | ✓ | ✓ | ✓ | ✓(only Pre-filled syringe with needle guard available in Aus) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Dose | 10 mg/0.1 mL 20 mg/0.2 mL 40 mg/0.4 mL 80 mg/0.8 mL |
20 mg/0.4 mL 40 mg/0.8 mL |
40 mg/0.8 mL | 40 mg/0.8 mL 40 mg/0.4 mL |
40 mg/0.8 mL | 40 mg/0.4 mL | 20 mg/0.4 mL 40 mg/0.8 mL |
20 mg/0.4 mL 40 mg/0.8 mL |
40 mg/0.8 mL | 20 mg/0.2 mL 40 mg/0.4 mL 80 mg/0.8 mL |
40 mg/0.4 mL 80 mg/0.8 mL |
40 mg/0.8 mL OR 40 mg/0.4 mL |
40 mg/0.8 mL 20 mg/0.4 mL 10 mg/0.2 mL 40 mg/0.4 mL |
40 mg/0.8 mL |
| Needle safety | No | No | ✓ Retraction |
✓ Retraction |
✓ Retraction |
✓ Retraction |
No | ✓ Retraction |
✓ Retraction |
No | ✓ Retraction |
✓ Retraction |
No | No |
| Needle gauge | 29G | 27G | 29G | 29G | 29G | 29G | 29G | 29G | 29G | 29G | 29G | 29G | 27G | 29G |
| Sound with delivery | No | No | No | No | No | No | No | No | No | No | No | No | No | No |
| Visual with delivery | No | No | ✓ Spring |
✓ Spring |
✓ Spring |
No | No | ✓ Spring |
✓ Spring |
No | ✓ Spring |
No | No | No |
| Shelf life (refrigerated) | 24 months | 36 months | 36 months | 30 months | 24 months | 36 months | 36 months | 36 months | 24 months | 36 months /20 mg 12 months | 36 months | 42 months | 24 months | Not reported |
| Shelf life (room temperature) | 14 days | 14 days | 28 days | 21 days | 14 days | 30 days | 30 days | 14 days | 14 days | 1 month | 30 days | 28 days | 14 days | 14 days |
| Latex-free | ✓ | AIP needle cap contains latex PFS is latex-free |
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | AIP and PFS needle caps contain latex | ✓ |
| Citrate content | 0 | 0 | 2.14 mg/0.8 mL dose | 0.18 mg/0.8 mL dose or 0 |
1 mg/0.8 mL dose | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
AIP, auto-injectable pen; PFS, prefilled syringe.
Table 3.
Patient support programs of currently listed biosimilars and reference adalimumab.
| Trade names | Humira | Amgevita Amjevita Adalimumab-Daiichi Sankyo |
Hadlima Adalloce |
Hyrimoz Halimatoz Hefiya |
Idacio | Yuflyma Adalimumab-CTNK |
Abrilada Amsparity Xilbrilada |
Hulio Adalimumab-FKB |
Exemptia | Xelenka Adalimumab-MA |
Hukyndra Adalicip Ciptunec Plamumab Cipleumab Simlandi |
Imraldi | Cyltezo | Yusimry |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Online portal | ||||||||||||||
| Australia | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | No information | NA | NA | NA | NA | NA | NA | NA |
| Canada | No information | No information | No information | No information | No information | ✓ | ✓ | No information | NA | NA | No information | NA | NA | NA |
| Hong Kong SAR | X | X | NA | X | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| India | NA | No information | NA | NA | NA | NA | NA | NA | ✓ | NA | No information | NA | NA | NA |
| Japan | X | ✓ | NA | NA | NA | X | NA | X | NA | X | NA | NA | NA | NA |
| Portugal | ✓ | ✓ | ✓ | |||||||||||
| Singapore | X | X | NA | No information | NA | X | No information | X | NA | NA | NA | NA | NA | NA |
| UK | X | ✓ | NA | ✓ | ✓ | No information | No information | No information | NA | NA | No information | ✓ | NA | NA |
| USA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | NA | NA | ✓ | NA | ✓ | ✓ |
| Patient training session | ||||||||||||||
| Australia | ✓ | ✓ | ✓ | ✓ | X | ✓ | No information | NA | NA | NA | NA | NA | NA | NA |
| Canada | No information | No information | No information | No information | No information | ✓ | ✓ | No information | NA | NA | No information | NA | NA | NA |
| Hong Kong SAR | Offered by nursing staff in public hospital | Offered by nursing staff in public hospital | NA | Offered by nursing staff in public hospital | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| India | NA | No information | NA | NA | NA | NA | NA | NA | ✓ | NA | No information | NA | NA | NA |
| Japan | X | ✓ | NA | NA | NA | X | NA | X | NA | X | NA | NA | NA | NA |
| Portugal | X | X | X | |||||||||||
| Singapore | ✓ | ✓ | NA | No information | NA | X | No information | No information | NA | NA | NA | NA | NA | NA |
| UK | X | ✓ | NA | X | ✓ | No information | No information | No information | NA | NA | No information | ✓ | NA | NA |
| USA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | NA | NA | ✓ | NA | ✓ | ✓ |
| Patient help hotline | ||||||||||||||
| Australia | ✓ | ✓ | ✓ | ✓ | X | ✓ | No information | NA | NA | NA | NA | NA | NA | NA |
| Canada | No information | No information | No information | No information | No information | ✓ | ✓ | No information | NA | NA | No information | NA | NA | NA |
| Hong Kong SAR | X | X | NA | X | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| India | NA | No information | NA | NA | NA | NA | NA | NA | ✓ | NA | No information | NA | NA | NA |
| Japan | ✓ | ✓ | NA | NA | NA | X | NA | X | NA | ✓ | NA | NA | NA | NA |
| Portugal | ✓ | ✓ | ✓ | |||||||||||
| Singapore | ✓ | ✓ | NA | No information | NA | X | No information | X | NA | NA | NA | NA | NA | NA |
| UK | X | X | NA | X | X | No information | No information | No information | NA | NA | No information | X | NA | NA |
| USA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | NA | NA | ✓ | NA | ✓ | ✓ |
| Nursing consultation | ||||||||||||||
| Australia | ✓ | ✓ | ✓ | ✓ | X | ✓ | No information | NA | NA | NA | NA | NA | NA | NA |
| Canada | No information | No information | No information | No information | No information | ✓ | ✓ | No information | NA | NA | No information | NA | NA | NA |
| Hong Kong SAR | X | X | NA | X | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| India | NA | No information | NA | NA | NA | NA | NA | NA | X | NA | No information | NA | NA | NA |
| Japan | X | X | NA | NA | NA | X | NA | X | NA | ✓ | NA | NA | NA | NA |
| Portugal | X | X | X | |||||||||||
| Singapore | ✓ | ✓ | NA | No information | NA | X | No information | No information | NA | NA | NA | NA | NA | NA |
| UK | X | X | NA | X | X | No information | No information | No information | NA | NA | No information | X | NA | NA |
| USA | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | NA | NA | ✓ | NA | ✓ | No information |
| Psychological support | ||||||||||||||
| Australia | X | X | X | X | ✓ | X | No information | NA | NA | NA | NA | NA | NA | NA |
| Canada | No information | No information | No information | No information | No information | ✓ | X | No information | NA | NA | No information | NA | NA | NA |
| Hong Kong SAR | X | X | NA | X | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| India | NA | No information | NA | NA | NA | NA | NA | NA | X | NA | No information | NA | NA | NA |
| Japan | X | X | NA | NA | NA | X | NA | X | NA | X | NA | NA | NA | NA |
| Portugal | X | X | X | |||||||||||
| Singapore | X | X | NA | X | NA | X | X | X | NA | NA | NA | NA | NA | NA |
| UK | X | X | NA | X | ✓ | No information | No information | No information | NA | NA | No information | X | NA | NA |
| USA | X | X | X | X | No information | X | X | X | NA | NA | X | NA | X | No information |
| Injection reminder | ||||||||||||||
| Australia | ✓ | ✓ | ✓ | ✓ | X | ✓ | No information | NA | NA | NA | NA | NA | NA | NA |
| Canada | No information | No information | No information | No information | No information | ✓ | ✓ | No information | NA | NA | No information | NA | NA | NA |
| Hong Kong SAR | X | X | NA | X | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| India | NA | No information | NA | NA | NA | NA | NA | NA | ✓ | NA | No information | NA | NA | NA |
| Japan | ✓ | X | NA | NA | NA | X | NA | X | NA | X | NA | NA | NA | NA |
| Portugal | X | X | X | |||||||||||
| Singapore | X | X | NA | X | NA | X | X | X | NA | NA | NA | NA | NA | NA |
| UK | X | ✓ | NA | X | No information | No information | No information | No information | NA | NA | No information | ✓ | NA | NA |
| USA | ✓ | X | X | ✓ | X | ✓ | ✓ | ✓ | NA | NA | ✓ | NA | No information | No information |
| Sharps container | ||||||||||||||
| Australia | ✓ | ✓ | ✓ | ✓ | X | ✓ | No information | NA | NA | NA | NA | NA | NA | NA |
| Canada | No information | No information | No information | No information | No information | ✓ | ✓ | No information | NA | NA | No information | NA | NA | NA |
| Hong Kong SAR | X | X | NA | X | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| India | NA | No information | NA | NA | NA | NA | NA | NA | X | NA | No information | NA | NA | NA |
| Japan | X | ✓ | NA | NA | NA | ✓ | NA | ✓ | NA | ✓ | NA | NA | NA | NA |
| Portugal | X | X | X | |||||||||||
| Singapore | X | X | NA | No information | NA | X | No information | No information | NA | NA | NA | NA | NA | NA |
| UK | X | ✓ | NA | X | ✓ | No information | No information | No information | NA | NA | No information | ✓ | NA | NA |
| USA | ✓ | No information | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | NA | NA | ✓ | NA | ✓ | No information |
| Travel pack | ||||||||||||||
| Australia | ✓ | ✓ | ✓ | ✓ | X | ✓ | No information | NA | NA | NA | NA | NA | NA | NA |
| Canada | No information | No information | No information | No information | No information | ✓ | ✓ | No information | NA | NA | No information | NA | NA | NA |
| Hong Kong SAR | X | X | NA | X | NA | NA | NA | |||||||
| India | NA | No information | NA | NA | NA | NA | NA | NA | ✓ | NA | No information | NA | NA | NA |
| Japan | ✓ | ✓ | NA | NA | NA | ✓ | NA | ✓ | NA | ✓ | NA | NA | NA | NA |
| Portugal | ✓ | ✓ | ✓ | |||||||||||
| Singapore | ✓ | ✓ | NA | No information | NA | X | No information | No information | NA | NA | NA | NA | NA | NA |
| UK | X | ✓ | NA | X | X | No information | No information | No information | NA | NA | No information | X | NA | NA |
| USA | ✓ | No information | ✓ | No information | No information | No information | ✓ | ✓ | NA | NA | No information | NA | ✓ | No information |
NA, Product not available in the region.
Figure 1.
Methods flow diagram.
In examining patient support systems across various countries, we gathered key information on the availability of services such as online portals, patient training sessions, help hotlines, nursing consultations, psychological support, injection reminders, sharps container provision, and travel packs. This information was obtained from official product websites and further supplemented by insights from our international authors: RL from Australia, CM from Canada, WL from Hong Kong SAR, RB from India, HN from Japan, FM from Portugal, HL from Singapore, CS from UK, and ST from the United States. Additional data were incorporated from pharmaceutical companies during product inquiries.
Results
Trade names and manufacturers
A total of 29 adalimumab products, including the originator Humira®, were identified worldwide. Comprehensive information was gathered for 14 of these products, which were included in our discussion. These comprised 13 adalimumab biosimilars: Amgevita/Adalimumab-Daiichi Sankyo (Amgen, Thousand Oaks, CA, USA), Hadlima/Adalloce (Organon & Co, Jersey City, NJ, USA), Hyrimoz/Halimatoz/Hefiya (Sandoz, Basel, Switzerland), Idacio (Fresenius Kabi, Bad Homburg, Germany), Yuflyma/Adalimumab-CTNK (Celltrion, Incheon, South Korea), Abrilada/Amsparity/Xilbrilada (Pfizer, NY, USA), Hulio/Adalimumab-FKB (Fujifilm Kyowa Kirin Biologics, Tokyo, Japan), Exemptia (Zydus Lifesciences, Ahmedabad, India), Xelenka/Adalimumab-MA (LG Chem, Seoul, South Korea), Hukyndra/Adalicip/Ciptunec/Plamumab/Cipleumab/Simlandi (Alvotech, Luxembourg), Imraldi (Samsung Bioepis, Songdo, Incheon, South Korea), Cyltezo (Boehringer Ingelheim, Ingelheim am Rhein, Germany), and Yusimry (Coherus BioSciences, Redwood City, CA, USA), alongside the originator molecule Humira® (AbbVie, North Chicago, IL, USA). Detailed characteristics of these products, including alternative trade names, available countries, and manufacturers, are presented in Table 1.
Table 1.
Trade names, available countries, and company details of currently listed biosimilars and reference adalimumab.
| Trade names | Humira | Amgevita Amjevita Adalimumab-Daiichi Sankyo |
Hadlima Adalloce |
Hyrimoz Halimatoz Hefiya |
Idacio | Yuflyma Adalimumab-CTNK |
Abrilada Amsparity Xilbrilada |
Hulio Adalimumab-FKB |
Exemptia | Xelenka Adalimumab-MA |
Hukyndra Adalicip Ciptunec Plamumab Cipleumab Simlandi |
Imraldi | Cyltezo | Yusimry |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Available countries (ISO 3166-2 country code) | United Arab Emirates, Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Egypt, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Latvia, Morocco, Mexico, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Poland, Puerto Rico, Portugal, Paraguay, Qatar, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Turkey, Taiwan, Ukraine, United States, Uruguay, South Africa | Amgevita (United Arab Emirates, Argentina, Austria, Australia, Belgium, Bulgaria, Canada, Chile, Colombia, Czech Republic, Germany, Ecuador, Estonia, Egypt, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, India, Italy, Jordan, Kenya, Lithuania, Luxembourg, Latvia, Mexico, Malaysia, Netherlands, Peru, Poland, Portugal, Paraguay, Qatar, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, South Africa) AMJEVITA (United States) Adalimumab (Daiichi Sankyo) (Japan) |
Hadlima (Australia, Canada, Puerto Rico, Qatar, Saudi Arabia, Ukraine, United StatesAU) Adalloce (South Korea) |
Hyrimoz (United Arab Emirates, Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Egypt, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ireland, Italy, Jordan, South Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Latvia, Mexico, Malaysia, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Turkey, Taiwan, Ukraine, United States, Uruguay, South Africa) Halimatoz (Ireland) Hefiya (Greece, Ireland) |
Austria, Australia, Belgium, Bulgaria, Canada, Chile, Colombia, Czech Republic, Germany, Denmark, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Italy, South Korea, Lithuania, Luxembourg, Latvia, Mexico, Malaysia, Netherlands, Norway, Peru, Poland, Portugal, Qatar, Romania, Saudi Arabia, Sweden, Slovenia, Slovakia, Taiwan, Ukraine, United States | Yuflyma (Austria, Australia, Belgium, Bulgaria, Canada, Chile, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Singapore, Slovenia, Slovakia, United States) Adalimumab CTNK (Japan) |
Abrilada (Australia, Canada, Switzerland, Colombia, Saudi Arabia, Singapore, Thailand, United States)Amsparity (Belgium, France) Xilbrilada (Brazil) |
Hulio (Austria, Belgium, Bulgaria, Canada, Chile, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Jordan, South Korea, Lebanon, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Poland, Portugal, Qatar, Romania, Sweden, Singapore, Slovenia, Slovakia, United States) Adalimumab FKB (Japan) |
India | Xelenka (South Korea) Adalimumab-MA (Japan) |
Hukyndra (Austria, Belgium, Bulgaria, Chile, Czech Republic, Germany, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Jordan, South Korea, Lebanon, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Poland, Portugal, Qatar, Romania, Sweden, Slovenia) Adalicip/ CIPTUNEC (Australia) Plamuma/Cipleumab (India) Simlandi (Canada, United States) |
Austria, Belgium, Bulgaria, Chile, Colombia, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, South Korea, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Sweden, Slovenia, Slovakia | United States | United States |
| Company | AbbVie | Amgen | Organon | Sandoz | Fresenius Kabi | Celltrion | Pfizer | Fujifilm Kyowa Kirin Biologics Co. Ltd. | Zydus Lifesciences Limited | LG Chem | Alvotech | Samsung Bioepis (Biogen and Samsung Bioepis) | Boehringer Ingelheim | Coherus BioSciences |
| Company headquarters | North Chicago, Illinois, USA | Thousand Oaks, California, USA | Jersey City, New Jersey, USA | Basel, Switzerland | Bad Homburg, Germany | Incheon, South Korea | New York, USA | Tokyo, Japan | Ahmedabad, India | Seoul, South Korea | Reykjavik, Iceland | Biogen—Netherlands Samsung Bioepis—Incheon, South Korea |
Ingelheim, Germany | Redwood City, California, USA |
| Country of manufacturing | Germany | USA | Italy | Austria | Switzerland | South Korea | USA | Japan | India | South Korea | Iceland | Denmark and South Korea | USA | USA |
The remaining 15 products were not widely marketed, unregistered in high incidence IBD countries, unavailable to respond to our inquiries, or did not provide patient or physician support services. Some of these products may not have met the full defining qualities and testing requirements required for the definition of a biosimilar. We searched the available information from the published Product Information documents to complete the database as best as possible. These products are as follows: Sulinno 40 mg/0.8 mL prefilled syringe (PFS) (Innovent Biologics, Shanghai, China), CinnoRA 40 mg/0.8 mL auto injectable pen (AIP) (CinnaGen, Tehran, Iran), Pamera 40 mg/0.8 mL AIP; 10 mg/0.2 mL, 20 mg/0.4 mL and 40 mg/0.8 mL PFS (Hetero biopharma, Jadcherla, India), Adalipca 40 mg/0.8 mL PFS (Ipca Laboratories, Maharashtra, India), Admira 40 mg/0.8 mL PFS (Tricos Dermatologics, Maharashtra, India), Envira 40 mg/0.8 mL PFS (Emcure Pharmaceuticals, Maharashtra, India), Amab 40 mg/0.8 mL PFS (Dr. Reddy’s Laboratories, Hyderabad, India), Mabvinra 40 mg/0.8 mL PFS (Alkem Laboratories, Mumbai, India), Adlumab 40 mg/0.8 mL PFS (RPG Life Sciences, Mumbai, India), Cadalimab 40 mg/0.8 mL PFS (Cadila Pharmaceuticals, Gujarat, India), Adfrar-P 40 mg/0.8 mL PFS (Torrent Pharmaceuticals, Ahmedabad, India), Adalirel 40 mg/0.8 mL PFS (Reliance Life Sciences, Maharashtra, India), Adalimac 40 mg/0.8 mL PFS (Macleods Pharmaceuticals, Mumbai, India), Adaly 40 mg/0.8 mL PFS and AIP (Glenmark Pharmaceuticals, Mumbai, India), and Mabura 40 mg/0.8 mL PFS and AIP (Hetero Healthcare, Hyderabad, India). Except for Sulinno, CinnoRA, and Pamera, the remaining products were manufactured and available exclusively in India.
Product characteristics
Of the 14 adalimumab products that were more commonly available, they share the same indications and are available in two delivery devices: AIPs and PFSs. All AIPs feature a retractable needle, whereas among PFS devices, only Hadlima, Hyrimoz, Idacio, Hulio, Hukyndra, Exemptia, Imraldi, and Yuflyma offer retractable needles that reduce needlestick injury risk.
All products utilize a uniform 29-gauge needle size except for Amgevita and Cyltezo PFS, which employ a larger 27-gauge needle. AIP devices have a visual window for confirming drug delivery, indicated by a colored bar or spring, accompanied by an audible sound. By contrast, PFS devices lack audible confirmation, with only Hadlima, Hyrimoz, Idacio, Hulio, Exemptia, and Hukyndra providing a spring for visual confirmation. The injection technique varies for AIP devices; Hadlima, Hyrimoz, Yuflyma, Hulio, Xelenka, Hukyndra, Imraldi, and Yusimry require a two-step technique of removing the cap and pressing onto the skin, while Humira®, Amgevita, Idacio, Abrilada, Exemptia, and Cyltezo involve an additional third step of pressing a button to deliver the drug.
Dosage options include 40 mg for all biosimilars. Exemptia is the only product offering 20 mg AIP, while Amgevita, Humira®, Abrilada, Hulio, Xelenka, and Cyltezo offer 20 mg PFS. Humira® and Hukyndra offer 80 mg AIP and PFS, while Xelenka only offers 80 mg PFS. Humira® and Cyltezo are the only products on the current market offering 10 mg PFS.
Notably, Humira®, Yuflyma, Xelenka, Hukyndra, and Imraldi offer a higher concentration of 100 mg/mL compared to the standard 50 mg/mL of other biosimilars. A citrate-free, high-concentration formulation of Hyrimoz was also approved in 2023 in the United States and Europe is increasingly available in other countries. 10 Similarly, Cyltezo features a citrate-free, high-concentration formulation that was approved by the FDA and has been available in the United States since May 2024. 11
All products, except Hadlima and Idacio, provide citrate-free formulations. Among the citrate-containing biologic agents, the original formulation of Hyrimoz has the lowest dose at 0.18 mg/0.8 mL, followed by Idacio at 1 mg/0.8 mL and Hadlima at 2.14 mg/0.8 mL.
Another notable difference among the products is the shelf life, with Imraldi offering the longest refrigerated shelf life, up to 42 months, followed by Amgevita, Hadlima, Yuflyma, Abrilada, Hulio, Xelenka, and Hukyndra, with a refrigerated shelf life of 36 months. More importantly, Yuflyma, Abrilada, Hukyndra, and Xelenka offer the longest shelf life outside the fridge, up to 30 days or 1 month. By contrast, Humira®, Idacio, Exemptia, and Cyltezo have the shortest shelf life, lasting 24 months when refrigerated and 14 days at room temperature. Yusimry also reports a room temperature shelf life of 14 days, but the refrigerated shelf life is not available during our review.
All mentioned agents are latex-free except for Cyltezo PFS/AIP and Amgevita AIP, which contain latex in the needle cap.
A comprehensive summary of the features of the adalimumab delivery devices is listed in Table 2.
Patient support program
We gathered information on the patient support program (PSP) provided by adalimumab products to determine whether this is driven by individual manufacturers or whether there were differences between countries. To achieve this, we surveyed key opinion experts and pharmaceutical companies in Australia, Canada, Hong Kong SAR, India, Japan, Portugal, Singapore, the United Kingdom, and the United States. Most products provide PSPs, albeit with variations in extent and coverage across countries. A summary of the PSPs available for adalimumab in these countries is presented in Table 3.
In Australia, each product offers an online portal providing patients with comprehensive information, training, and support. Educational videos on injection techniques are available from all companies. Patient training sessions, whether in-person or virtual, are offered by all companies except those receiving Idacio. Patient help hotline is available for patients receiving Humira®, Hadlima, Amgevita, Hyrimoz, Adalicip, and Yuflyma. Idacio stands out by providing online cognitive-behavioral therapy modules for psychological support, while Amgevita and Hadlima offer online psychological support resources through the SupportED website. Patients using Humira® can benefit from health coaching with up to four personalized phone calls per year, covering individual needs such as nutritional support or smoking cessation. Various companies offer medication adherence reminders, including fridge magnets and reminder cards. Amgevita, Hadlima, and Yuflyma provide text or email injection reminders, while Amgevita, Hadlima, Yuflyma, and Humira® offer script reminders through similar means. In addition, Amgevita and Hadlima provide reminders for blood tests. All products, except Idacio, provide sharps containers and travel/cooler packs for patients.
In Canada, expert opinion suggests that most products offer comprehensive PSPs, which typically include injection education and nursing consultant services. We gathered further information on Yuflyma and Abrilada via pharmaceutical representatives. Abrilada provides an online portal called PfizerFlex, accessible to patients. This portal features educational videos on injection techniques, nursing consultant support, and educational resources for patients. It also offers a patient hotline and adherence calls, or SMS injection reminders. In addition, Abrilada supplies sharps containers, travel packs, and travel instructions at no cost to patients. Yuflyma offers a similar support program but goes a step further by including psychological and nutritional support, covering up to three sessions with a psychologist and a nutritionist. Furthermore, a health coach is available via an app, providing a holistic approach to managing IBD through resources such as meditation, psychological support, and more.
In the United Kingdom, Amgevita, Idacio, Hyrimoz, and Imraldi offer PSPs with online portals accessible to patients. All except Hyrimoz provide video education on injection techniques. Similar to Australia, Idacio is the only product offering online cognitive-behavioral therapy modules for psychological support. Amgevita and Imraldi offer injection and prescription reminders. Sharps containers are provided by Amgevita, Idacio, and Imraldi, with Amgevita being the only company to offer travel packs. None of these products provides a patient help hotline or nurse consultant services in the United Kingdom. Of note, healthcare providers in the United Kingdom can purchase biosimilars with a home care and patient support program for patients included, or purchase the biosimilar without the manufacturer’s offered home care and patient support program.
In the United States, all products offer an online portal, injection training (in person or online), and a patient helpline. All products except Yusimry offer nursing consultation; for Yusimry, this information was not available. While Idacio provides online cognitive-behavioral therapy in Australia and the United Kingdom, we were unable to confirm whether this support is available in the US market. Injection reminders are offered by Humira, Hyrimoz, Yuflyma, Abrilada, Hulio, and Simlandi. Free sharps containers are provided by all products except Amgevita and Yusimry, where this information was not available. Travel packs are confirmed to be offered by Humira, Hadlima, Hulio, and Cyltezo. For the remaining products, information on travel pack availability was not available at the time of this review.
In Japan, Humira® is the only product that offers PSP. “Humira® Support Tool Ordering Service for Patients” is a program designed to assist patients on Humira® by delivering support tools directly to their homes. These tools include sharps containers, disease-specific health management notebooks, and medication guides tailored to their condition. While Humira®, Amgevita, Xeljanz, and Hulio offer patient hotlines, most online portals are inaccessible in Japan, with the exception of Amgevita. Injection reminders are available only for Humira®, and none of the products provide prescription reminders. All products, however, supply sharps containers and cool packs.
In Portugal, only Humira® and Idacio offer PSPs. However, Humira®, Amgevita, Idacio, and Hulio provide online portals with treatment-related resources, and all products include a patient help hotline. Video education, nurse consultant services, and psychological support are not available for any of these products. In addition, prescription and injection reminders are not offered in the Portuguese market. While all products provide travel packs, sharps containers are not routinely supplied.
In India, Exemptia provides virtual patient training sessions, access to an online portal, and a patient hotline. Patients can receive injection reminders via text messages and calls, with the option of a medication home delivery service. Sharps containers and travel/cooler packs are also provided to patients upon initiating treatment. Of note, the highest range of biosimilar adalimumab is available in India, and the originator is unavailable.
In Singapore, PSPs, training sessions, patient hotlines, nurse consultations, and video education are available for patients using Humira® and Amgevita. However, online portals for these products are not accessible in Singapore. Injection and prescription reminders are not available, and while travel or cooler packs are available for both products, sharps containers are not provided.
In Hong Kong, patient support is managed by the local Hospital Authority. At present, none of the adalimumab products offer PSPs in the region.
Discussion
When prescribing biosimilars, healthcare providers consider factors beyond efficacy and safety. Financial implications owing to differences in biosimilar prices drive system-wide prescribing decisions in healthcare settings like the United Kingdom, for example. Considerations such as ease of administration, tolerability, and patient satisfaction are crucial for improving treatment adherence. However, prescribers may not always be aware of the variations in delivery device design, dose formulations, support services, and excipient content among available options. Therefore, this study aims to shed light on the non-clinical factors of currently available adalimumab products worldwide, emphasizing the differences to aid informed decision-making by clinicians.
Studies comparing AIP and PFS have indicated a preference for AIP among patients or caregivers administering the medication. In a study comparing the user experience of methotrexate AIP versus PFS in 23 pediatric juvenile idiopathic arthritis patients, the perceived level of pain was significantly lower with the use of AIP, and caregivers rated AIP as easier to use compared to PFS. 12 Similarly, a study evaluating the preferences of 91 ulcerative colitis patients receiving golimumab found a higher preference for AIPs, citing ease of use and reduced discomfort. 13 Although the underlying reason is unclear, it is possible that the invisibility of the AIP needle throughout the administration process reduces psychological stress, thereby decreasing the subjective sensation of pain and boosting the confidence of the administrator. Another advantage of AIP devices is that they provide visual and auditory prompts for drug delivery. By contrast, visual spring bars for delivery are only available in selected PFS devices—namely Hadlima, Hyrimoz, Idacio, Hulio, Hukyndra, Exemptia, Imraldi, and Yuflyma—and auditory cues are not available. These visual and auditory prompts of AIP can be advantageous for patients with limited proficiency in drug administration, assisting in ensuring accurate drug delivery and enhancing the confidence of self-administration.
The availability of various dosage options enables tailored treatment for specific indications. For instance, the 80 mg dosage option can reduce the number of injections required for Crohn’s disease and ulcerative colitis induction therapy, which typically involves 160 mg in week 0, followed by 80 mg in week 2 and 40 mg in week 4. The 20 mg dosage is tailored for maintenance doses in pediatric Crohn’s disease or ulcerative colitis management, while the 10 mg dosage can be utilized in pediatric juvenile idiopathic arthritis or non-infectious uveitis. While all products provide a standard 40 mg/0.4 mL AIP and PFS, Humira® offers the widest range of dose options. This includes 10 mg/0.1 mL, 20 mg/0.2 mL, and 80 mg/0.8 mL in their PFS range. Xelenka also offers 80 mg/0.8 mL and 20 mg/0.2 mL PFS options, while Hukyndra only offers 80 mg/0.8 mL PFS. In addition, Humira® and Hukyndra are the only two products that offer 80 mg/0.8 mL AIP.
Several factors contribute to injection site pain, including needle size, citrate content, and injection volume. This discomfort can significantly impact a patient’s adherence to treatment, especially for those particularly sensitive to injection pain. Amgevita and Cyltezo’s PFS devices use a larger 27-gauge needle, deviating from the standard 29-gauge, which may heighten injection pain. 14 The link between citrate content and injection site pain is well documented, as citrate has been shown to enhance pain behavior through acid-sensing ion channels. 15 Notably, Hadlima boasts the highest citrate content, resulting in the most injection site pain, followed by Idacio and the conventional formulation of Hyrimoz. Similarly, larger injection volumes correlate with increased injection site discomfort. 16 Products like Humira®, Yuflyma, Xelenka, Hukyndra, and Imraldi offer high-concentration formulations, which generally present a more favorable pain profile. Given the growing demand for high-concentration, citrate-free formulas, companies are developing new formulations to meet market demands. For instance, Hyrimoz recently introduced a high-concentration, citrate-free formula, now available in both Europe and the United States.
It is important to note that Amgevita's AIP and all Cyltezo products contain latex in the needle cap, making them unsuitable for patients with latex allergies.
One of the key advantages of adalimumab over other biological agents lies in its self-administration feature, allowing patients to sustain their medical regimen even during travel. Consequently, the duration it can remain effective outside the refrigerator becomes a critical consideration. Yuflyma, Abrilada, Hukyndra, and Xelenka stand out by offering the longest shelf life outside the fridge, extending up to 30 days. Furthermore, they include travel or cooler packs in certain countries, rendering them particularly suitable for patients who frequently travel and may not always have access to refrigeration facilities.
PSPs vary significantly across countries, with Australia, Canada, and the United States offering some of the most comprehensive services compared to those in Japan, Singapore, Portugal, the United Kingdom, and Hong Kong SAR. Due to limited data, it is difficult to assess the full scope of PSPs in India. These programs encompass a wide array of features, including patient online portals, in-person or virtual training sessions, patient hotlines, and prescription or injection reminders. While the availability of these services is influenced by local regulations, the competitive landscape also plays a key role, as biosimilar companies strive to offer support comparable to their counterparts. For instance, in the past year, Amgevita and Hadlima in Australia have rolled out online portals and virtual patient training sessions, aligning themselves with offerings from Humira®, Hyrimoz, and Yuflyma. It is imperative for prescribers and pharmacists to remain mindful of the availability of such services in their respective countries and to offer guidance to patients in areas where support may be lacking.
Strengths and limitations
This review has several strengths. First, we conducted an extensive search through regulatory authorities worldwide to compile a comprehensive list of adalimumab products available globally. Product information was gathered from published Product Information documents, complemented by interviews with pharmaceutical representatives to address any gaps in data. This approach ensures that the information gathered is comprehensive and reliable. In addition, the review incorporates insights from a panel of international experts. Their perspectives offer insights into the differences in PSPs across different countries, providing useful context for our international readers regarding potential disparities in the PSPs and anticipated developments in the future. Furthermore, we have presented the information in a user-friendly manner, with features conveniently categorized by delivery devices to allow easy comparison of these features among all the biosimilar and reference adalimumab products. We believe this will serve as a handy reference tool for prescribing decisions.
One limitation of this study is that the data reflect information available only up to the time when the interviews were conducted. The landscape of biosimilars is continually evolving, implying that new formulations, support programs, and training initiatives may have emerged since then. Hence, it is crucial for readers to seek the most updated information from local pharmaceutical companies or other reliable sources. In addition, despite our efforts to include all available products on the market, we encountered challenges in gathering sufficient information on 15 products. However, it is worth noting that 12 of these products were manufactured in India and were only available locally. As such, the impact of these missing data may be minimal for most international readers.
Conclusion
In summary, this article offers a comprehensive comparison of adalimumab products worldwide, assessing practical endpoints and factors influencing their usability in real-world settings. Favorable attributes of these products include the availability of AIPs, high concentration, citrate-free formulations, wide dosage range, extended shelf life, and robust patient support services. It is important to recognize that there is no universally ideal agent suitable for all patients. Although Humira® has very good non-pharmacological characteristics and support services, cost reduction is typically driven by the availability of biosimilars. These findings underscore the significance of a personalized approach to prescribing, considering the unique needs of the patient. The inclusion of a user-friendly comparison table enables clinicians to make more informed prescribing decisions by directly comparing different agents. This resource facilitates the selection of the most suitable option based on the specific requirements of each patient.
Acknowledgments
None.
Footnotes
ORCID iDs: Tsz Hong Yiu 
https://orcid.org/0000-0002-0438-0739
Wai Keung Leung
https://orcid.org/0000-0002-5993-1059
Hiroshi Nakase
https://orcid.org/0000-0003-2848-6586
Huiyu Lin
https://orcid.org/0000-0001-8779-6010
Christopher Ma
https://orcid.org/0000-0002-4698-9948
Fernando Magro
https://orcid.org/0000-0003-2634-9668
Stacy Tse
https://orcid.org/0000-0001-8134-0362
Christian Selinger
https://orcid.org/0000-0003-2022-5859
Rupert W. Leong
https://orcid.org/0000-0001-5944-3488
Contributor Information
Tsz Hong Yiu, Department of Gastroenterology, The University of Sydney, Footscray, VIC, Australia.
Emilia Anderson, Gastroenterology and Liver Services, Concord Repatriation General Hospital, Sydney, NSW, Australia.
Wai Keung Leung, Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.
Hiroshi Nakase, Department of Gastroenterology and Hepatology, School of Medicine, Sapporo Medical University, Chuo-Ku, Sapporo, Hokkaido, Japan.
Rupa Banerjee, Department of Medical Gastroenterology, Asian Institute of Gastroenterology and AIG Hospitals, Gachibowli, Hyderabad, India.
Huiyu Lin, Gastroenterology and Liver Services, Concord Repatriation General Hospital, Sydney, NSW, Australia; Department of Gastroenterology and Hepatology, Tan Tock Seng Hospital, Singapore, Singapore.
Christopher Ma, Division of Gastroenterology, University of Calgary, Calgary, AB, Canada.
Fernando Magro, Faculty of Medicine, The University of Porto, Porto, Portugal.
Stacy Tse, Susan and Leonard Feinstein IBD Clinical Center, Mount Sinai Hospital, New York, NY, USA.
Bruce E. Sands, Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA
Christian Selinger, Leeds Gastroenterology Institute, Leeds Teaching Hospitals, Leeds, UK.
Rupert W. Leong, Gastroenterology and Liver Services, Concord Repatriation General Hospital, Level 1 West, Concord Hospital, 1 Hospital Road, Sydney, NSW 2139, Australia.
Declarations
Ethics approval and consent to participate: Not applicable.
Consent for publication: Not applicable.
Author contributions: Tsz Hong Yiu: Conceptualization; Data curation; Formal analysis; Investigation; Methodology; Project administration; Writing – original draft; Writing – review & editing.
Emilia Anderson: Conceptualization; Methodology.
Wai Keung Leung: Data curation; Resources.
Hiroshi Nakase: Data curation; Resources.
Rupa Banerjee: Data curation; Resources.
Huiyu Lin: Data curation; Resources.
Christopher Ma: Data curation; Resources.
Fernando Magro: Data curation; Resources.
Stacy Tse: Data curation; Resources.
Bruce E. Sands: Data curation; Resources.
Christian Selinger: Data curation; Resources.
Rupert W. Leong: Conceptualization; Data curation; Methodology; Project administration; Resources; Writing – review & editing.
Funding: The authors received no financial support for the research, authorship, and/or publication of this article.
Competing interests: WKL received speaker’s fee from AbbVie, Ferring, and Johnson & Johnson; honorarium for attending advisory board from Astra Zeneca, Bicodex, and Johnson and Johnson. HN received personal fees from Abbvie Inc., Kissei Pharmaceutical Co., Ltd., KYORIN Pharmaceutical Co., Ltd, Mitsubishi Tanabe Pharma Corporation, Janssen Pharmaceutical K.K, Takeda Pharmaceutical Co., Ltd., Pfizer Japan Inc., EA Pharma Co., Ltd., Mochida Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Gilead Sciences Inc., VIATRIS Inc., JIMRO Co., Ltd., and grants for commissioned/joint research from Hoya Group Pentax Medical, Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., and Abbvie Inc. He has endowed chair by Miyarisan Pharmaceutical Co., Mochida Pharmaceutical Co., Ltd. JIMRO Co., Ltd., and KYORIN Pharmaceutical Co., Ltd. ST served on the Advisory Board for Bristol Myers Squibb. HL received honorarium from Johnson & Johnson Singapore and sponsorship from Ferring. CM received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma Inc, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Forte Biosciences, Fresenius Kabi, Gilead, Janssen, McKesson, Mirador Therapeutics, Mylan, Pendopharm, Pfizer, Prometheus Biosciences Inc., Roche, Sanofi, Takeda, Tillotts Pharma; speaker's fees from AbbVie, Amgen, AVIR Pharma Inc, Alimentiv, Bristol Myers Squibb, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Merck, Organon, Pendopharm, Pfizer, Sanofi, Takeda, Tillotts Pharma; royalties from Springer Publishing; research support from AbbVie, Eli Lilly, Ferring, Pfizer. BES reports consulting fees from Abbvie, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, Arena Pharmaceuticals, Artugen Therapeutics, Astra Zeneca, Biolojic Design, Biora Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Calibr, Celgene, Celltrion, ClostraBio, Equillium, Enthera, Envied Biosciences, Evommune, Ferring, Fresenius Kabi, Fiat, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Imhotex, Index Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Kaleido, Kallyope, Merck, Microbiotica, Mitsubishi Tanabe, Mobius Care, Morphic Therapeutics, MRM Health, Nexus Therapeutics, Nimbus Discovery, Odyssey Therapeutics, Palisade Bio, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biopharma, Sanofi, Sorriso Therapeutics, Spyre Therapeutics, Sun Pharma, Surrozen, Target RWE, Teva, TLL Pharmaceutical, Tr1X, Union Therapeutics, Ventyx Biosciences; consulting and speaking fees from Abivax; consulting and speaking fees and other support from Lilly; research grants, consulting and speaking fees and other support from Bristol Myers Squibb, Janssen, Pfizer, Takeda; research grants and consulting fees from Theravance Biopharma; and stock/stock options from Ventyx Biopharma. RL is an associated editor of TAG and a co-author of this article. RL has also served as an advisory board member of AbbVie, Aspen, BMS, Celgene, Celltrion, Chiesi, Ferring, Glutagen, Hospira, Janssen, Lilly, MSD, Novartis, Pfizer, Prometheus Biosciences, and Takeda. RL is also a research grant recipient from Celltrion, Shire, Janssen, Takeda, Gastroenterological Society of Australia, NHMRC, Gutsy Group, Pfizer, and Joanna Tiddy grants at the University of Sydney. AP is an advisory board member of AbbVie and has received speaker fees from AbbVie and Takeda. TY, EA, RB, CM, FM, and CS declare no conflicts of interest. The Associate Editor of Therapeutic Advances in Gastroenterology is an author of this paper, therefore, the peer review process was managed by alternative members of the Board and the submitting Editor had no involvement in the decision-making process.
Availability of data and materials: Share upon reasonable request.
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