Table 3. Resources for Health-Care Providers.
| Organization | Description of resources | Reference/Link |
|---|---|---|
| US Food and Drug Administration (FDA) product information | A repository of FDA-licensed biosimilar products with links to prescribing information. | https://www.fda.gov/drugs/biosimilars/biosimilar-product-information |
| US FDA Biosimilar Guidances | Biosimilars guidance drafted for industry. | https://www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/biosimilars-guidances |
| US FDA | A premier source of regularly updated information on biosimilar topics relevant to the education of health-care professionals. Also available are healthcare-provider outreach materials such as webinars, videos, fact sheets, FDA staff presentations and articles, infographics, and a stakeholder toolkit with links to social media posts (i.e., Twitter, Facebook, and LinkedIn) among other tools, including patient materials. | https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars |
| US FDA | All the FDA Guidance documents concerning their interpretation of policy on regulatory issues relevant to biologics, which includes biosimilars. Covered are the design, production, labeling, promotion, manufacturing, and testing of regulated products, as well as inspection and enforcement policies, among other aspects. | https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances |
| US FDA Center for Drug Evaluation and Research | The “Purple Book” lists all available US FDA-licensed biological products showing exclusivity expiry dates and biosimilarity or interchangeability evaluations to date. | https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/purple-book-lists-licensed-biological-products-reference-product-exclusivity-and-biosimilarity-or |
| National Comprehensive Cancer Network (NCCN) | A platform (with free registration) that provides the NCCN guidelines by cancer site and includes a reference to FDA-licensed biosimilars within the context of the current clinical practice guidelines in oncology for: breast cancers, cervical cancers, central nervous system cancers, rectal cancers, non-small cell lung cancers, B-cell lymphoma, kidney cancers, chronic lymphocytic leukemia/small lymphocytic lymphoma. | https://www.nccn.org/guidelines/category_1 |
| National Conference of State Legislatures (NCSL) | State laws and legislation related to biologic medications and substitution of biosimilars (enacted state laws, state-by-state). | http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx |
| Congress.Gov | Search this website to learn about and track US legislative bills related to biosimilars that have been introduced into Congress. A search term of “biosimilar” will yield many results that can subsequently be refined according to need. | http://www.congress.gov |
| MedWatch | The FDA safety information and adverse event-reporting program. | https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program |
| American Society of Clinical Oncology (ASCO) CancerLinQ database | A network designed to improve patient care via the transfer of a practice's electronic health record into the secure CancerLinQ platform. Large amounts of real-world data are de-identified, sorted, and harmonized to provide quality metrics in real-time, which can help inform clinicians’ care decisions. | https://www.cancerlinq.org/ |
| Biosimilars Council | A website with a multitude of materials, videos, blogs, news, and other resources. | https://biosimilarscouncil.org/resources/ |
| Biosimilars Forum | A website hosting evidence-based information to inform and support public policies pertaining to biosimilars, with links to downloadable educational resources, the latest news on biosimilars, and surveys of interest. | http://www.biosimilarsforum.org/ |
| European Medicines Agency (EMA) | European guidelines relevant to biosimilars, specific biosimilar products, and other guidelines relevant for biosimilars. | https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/multidisciplinary/multidisciplinary-biosimilar |
| The Center for Biosimilars | News, resources by specialty (including oncology), multimedia (insights, interviews, peer exchange and podcasts), upcoming conferences, approved biosimilars, etc. | https://www.centerforbiosimilars.com/about |
| European Specialist Nurses Organisation (ESNO) | An EU information and communication guide for nurses addressing efficient switching from biological medicines to biosimilars. It includes FAQs and sample answers that, although they will differ by country/region/hospital, could be adapted to fit specific circumstances. | https://www.esno.org/publications.html#header1-3f |
| Cancer Connect | Information about biosimilar medications for the treatment of cancer and topline information covering interchangeability, extrapolation, and the cost of biosimilars. | https://news.cancerconnect.com/treatment-care/biosimilar-drugs-and-cancer-treatment-what-you-need-to-know |
| Oncology Nursing Society (ONS): An oncology nursing overview of biosimilars | A nursing overview of biosimilars with an embedded article (requires ONS membership). | https://voice.ons.org/news-and-views/an-oncology-nursing-overview-of-biosimilars |
| National Institutes of Health – National Cancer Institute | News and events information (a blog) on the emergence of biosimilars for the treatment of cancer. Explanations are provided for various concepts related to biological products, extrapolation, interchangeability, and the European experience with biosimilars. | https://www.cancer.gov/news-events/cancer-currents-blog/2018/biosimilars-cancer-treatment |
| Position statements | ||
| American Society of Clinical Oncology (ASCO) | Lyman, GH, et al. ASCO statement: biosimilars in oncology. J Clin Oncol. 2018;36:1260–5. | https://ascopubs.org/doi/pdfdirect/10.1200/JCO.2017.77.4893 |
| National Comprehensive Cancer Network (NCCN) Biosimilars Work Group discussions and Policy Summit | NCCN Biosimilars White Paper: Regulatory, Scientific, and Patient Safety Perspectives. 2011 | https://jnccn.org/view/journals/jnccn/9/Suppl_4/article-pS-1.xml |
| Academy of Managed Care Pharmacy (AMCP) | Pharmacy-focused professional organization that supports the provision of “positive health-care outcomes through quality, accessible, and affordable pharmaceutical care.” A position statement and other policy and advocacy resources related to biosimilars can be accessed from the AMCP site. | https://www.amcp.org/policy-advocacy/policy-resource-center/where-we-stand-position-statements |
| International Coalition of Medicines Regulatory Authorities (ICMRA) | ICMRA statement about confidence in biosimilar products (for health-care professionals). | https://www.icmra.info/drupal/sites/default/files/2019-07/ICMRA_statement_about_confidence_in_biosimilar_product_HCP.PDF |
| Community Oncology Alliance (COA) | Position statement. | https://communityoncology.org/wp-content/uploads/2019/04/Biosimilars-positiion-statement-.pdf |
| Biosimilar Medicines (EU) | A summary of EU position statements on physician-led switching for biosimilar medicines (Sept 2019). | https://www.medicinesforeurope.com/wp-content/uploads/2017/03/M-Biosimilars-Overview-of-positions-on-physician-led-switching.pdf |
| ISOPP International Society of Oncology Pharmacy Practitioners | Resources relevant to oncology pharmacists. | https://www.medicinesforeurope.com/wp-content/uploads/2017/03/M-Biosimilars-Overview-of-positions-on-physician-led-switching.pdf |
| European Society for Medical Oncology (ESMO) | The ESMO position paper on biosimilars in oncology: enhancing the provision of accurate education and information. 2017. Biosimilars: A position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. 2016. | https://www.esmoopen.com/article/S2059-7029(20)32437-6/fulltext https://www.esmoopen.com/article/S2059-7029(20)32501-1/fulltext |
Note. EU = European Union; FAQs = frequently asked questions. Information from National Conference of State Legislatures, (2019); Pittman et al. (2019).