TABLE 4.
Measures to foster biosimilar prescribing aimed at physicians.
| Country | INN prescribing | Prescribing of biologics/biosimilars | |||
|---|---|---|---|---|---|
| Applied | Bindingness | Prescribing guidelines and recommendations | Position papers/documents | URL of the position papers/documents | |
| AT | No | Not allowed | Yes; physicians must prescribe the most economical medicine among therapeutically equivalent alternatives (including biosimilars) | “Guidelines for the economical prescribing of medicines and therapeutic aids (RöV 2005)” of the Austrian Social Insurance | https://www.ris.bka.gv.at/Dokumente/Avsv/AVSV_2005_0005/AVSV_2005_0005.pdfsig |
| BE | Yes | Generally voluntary, but not recommended for biologics | Yes; prescribing quotas (differing per medical specialty) for “cheap medicines” (including biosimilars) | Agreement between the state, some professional associations, the association of hospital pharmacists and the pharmaceutical industry to foster the use of biosimilars, reached in 2016; the agreement became part of the framework agreement with the pharmaceutical industry (“Pact for the future”) | https://www.inami.fgov.be/SiteCollectionDocuments/convention_medicaments_biosimilaires_belgique.pdf |
| Recommendation of biosimilar prescribing for naive patients, switching to and between biosimilars is possible (but must be monitored) | 2020: Establishment of a task-force to enhance the market dynamics | https://pharma.be/fr/component/attachments/attachments.html?task=attachment&id=235 | |||
| CZ | Yes | Voluntary | Yes; recommendation of biosimilar prescribing for naive patients, switching to and between biosimilars is possible | Guidelines of the Medical Profession | https://www.linkos.cz/ceska-onkologicka-spolecnost-cls-jep/stanoviska-cos/tiskove-centrum/opinion-of-the-czech-society-for-oncology-on-the-possibility-of-biosimilar-subst/ |
| DE | Yes | Voluntary, but pharmacist has to consult with prescribing doctor in case of an INN prescribing for a biologic (except for “bioidenticals” a ) | Yes; medicines agreements between prescribers and sickness funds on prescribing quotas and selective contracts (integrated contracts), switching recommended in conjunction with continuous monitoring | Guideline of the Pharmaceutical Commission of the German Medical Profession Association on biosimilars | https://www.akdae.de/Arzneimitteltherapie/LF/PDF/Biosimilars.pdf |
| DK | No | Not allowed | Yes; recommendation of biosimilar prescribing for naive patients, and of switching to and between biosimilars | Recommendations of the Danish Health Council | https://medicinraadet.dk/anbefalinger-og-vejledninger/vurderinger-af-biosimilaere-laegemidler |
| ES | Yes | Mandatory | Yes; switching is possible and the decision is taken by the physician | — | — |
| FI | Yes | Voluntary | Yes; obligation to prescribe the most economical therapeutic alternative for all (not only naive) patients, when biosimilars are available. Prescribing of a more expensive alternative must be justified in writing in the patient’s medical record | Decree of the Ministry for Social Affairs and Health (on prescribing of economical therapeutic alternatives); position paper of the regulatory authority on the interchangeability of reference medicines and biosimilars | https://www.fimea.fi/documents/542809/838272/29197_Biosimilaarien_vaihtokelpoisuus_EN.pdf |
| FR | Yes | Mandatory, but not allowed for biologics (consulting of pharmacist with prescriber is required) | Yes; contractual obligation for physicians affiliated with social security to prescribe a min of 20% biosimilars for insuline glargine; switching recommended by the National Health Authority | Written recommendation by the National Health Authority | https://www.has-sante.fr/portail/upload/docs/application/pdf/2017-11/bum_medicaments_biosimilaires_v1.pdf |
| IE | Yes | Voluntary | Yes; switching is recommended under specific circumstances—e.g. stable, well-supervised patients, clinical monitoring, provision of patient information—as biosimilars are not considered interchangeable with reference medicines | Currently none | https://health.gov.ie/wp-content/uploads/2017/08/National-Biosimilar-Medicines-Policy-Consultation-Paper-2017.pdf |
| A national biosimilar policy is under development (based on a consultation paper August 2017) | |||||
| IT | Yes | Mandatory | Yes; the decision to switch rests with the physician, but biosimilar prescribing and switching is recommended and there are prescribing quotas in some regions | Position paper of the national Medicines Agency (2018 version) | http://www.aifa.gov.it/sites/default/files/pp_biosimilari_27.03.2018.pdf |
| NL | Yes | Voluntary | Yes; switching is recommended | Position papers of regulatory agency and Medical Profession published on their websites | https://www.cbg-meb.nl/onderwerpen/medicijninformatie-originele-biologische-medicijnen-en-biosimilars/extra-medische-informatie-voor-zorgverleners |
| https://www.demedischspecialist.nl/sites/default/files/Standpunt%20Biosimilars%20Federatie%20Medisch%20Specialisten.PDF | |||||
| NO | Yes | Voluntary | Yes; switching is recommended | Position paper of regulatory agency NOMA published on their website | https://legemiddelverket.no/nyheter/switching-between-a-reference-product-and-a-biosimilar |
| PT | Yes | Mandatory | Yes; recommendation to opt for substances which have biosimilar and prescribe and start naive patients on the most economical alternative; switching is possible under specific circumstances (e.g. pharmacovigilance) | Guidelines of the national Pharmaceutical Commission published on the website of medicines agency INFARMED | http://www.infarmed.pt/documents/15786/1816213/1_Orienta%C3%A7%C3%B5es_CNFT_Completa_Final.pdf/bd4475fc-147b-4254-a546-03b8cd63efff |
| http://www.infarmed.pt/documents/15786/1816213/1_Orienta%C3%A7%C3%B5es_CNFT_Resumo_Final.pdf/a0e7f259-ec02-45a4-8700-994e712a4f14 | |||||
| SE | No | Not allowed | Yes; choice between reference medicine or biosimilar(s) rests with the physician. Physicians are urged to consider all factors including safety, effectiveness, and price difference. Multiple switching is not recommended | Report of the Medicines Agency with recommendation | https://www.lakemedelsverket.se/sv/tillstand-godkannande-och-kontroll/tillverkningstillstand/biologiska-lakemedel#hmainbody1 |
| SK | Yes | Mandatory | Yes; switching is possible | Background papers explaining biosimilars (primarily addressed to patients) | https://www.sukl.sk/buxus/docs/odpovede_na_otazky_o_biologickych_liekoch.SUKL.pdf |
| UK | (Yes) | Generally voluntary, but not allowed for biologics | Yes; choice between reference medicine or biosimilar(s) rests with the physician. Physicians are urged to choose “best value.” Switching is allowed under certain preconditions (shared decision-making with patients, monitoring mechanisms) | Guidance document on biosimilars by regulatory agency | https://www.england.nhs.uk/medicines/biosimilar-medicines |
INN = International Non-Proprietary Name.
a
Bioidenticals are defined as medicines which do not differ in chemical precursors and manufacturing process. They were produced in the same production site and are marketed by different pharmaceutical companies under different brand names (co-marketing).