Biosimilar use has led to increased access to biological treatments for some molecules wherein switching from originator to biosimilar has been one means to exchange products [1, 2]. Another but less applied way to exchange the products is via substitution by a pharmacist, i.e. without informing the prescriber . Substitution of biosimilars is a topic with many contrasting views and has been highly debated [3-12]. More clarity on the matter is needed because health care has reached a point where policy decisions need to be made about whether substitution should become a practice in biosimilar use. Therefore, researchers from Denmark, Sweden and The Netherlands investigated the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars .
The study used qualitative interviews wherein European Union (EU) national medicines regulators and industry experts expressed high confidence in the science behind exchanging biosimilars for reference products via switching, i.e. with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e. without physician involvement. Despite this, only a few participants saw the need for additional scientific data to support substitution. In addition, the participants reported that interchangeability also pertains to regulatory practices and trust, and thus is not only a matter of scientific likeness between biosimilar and reference products .
The results showed that biosimilar companies lack interest in substitution and are therefore not expected to drive change in this area . However, other developments in the area include publication of the strategies of the European Commission (EC) and the European Medicines Agency (EMA) [14-15]. These show that the EC is considering the political and financial aspects of substitution of biosimilars, but also that the EMA is not expected to play an increasing role in the science underpinning interchangeability. Nonetheless, these two stakeholder strategies will shed light on how biosimilar substitution will look in the EU, and this is likely to influence other jurisdictions.
Conflict of interest
The authors of the research paper  reported conflict of interest, including being funded by a PhD fellowship grant to the University of Copenhagen from Leo Pharma. For full details of the authors’ conflict of interest, see the research paper .
Abstracted by Louise C Druedahl, MScPharm, PhD, Copenhagen Centre for Regulatory Science (CORS)/Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen, Denmark.
Readers interested to learn more about interchangeability for biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Interchangeability. An insurmountable fifth hurdle?
GaBI Journal is indexed in Embase, Scopus, Emerging Sources Citation Index and more.
Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.
GaBI Journal Citation Impact
1.9 – CiteScore 2020 (calculated on 5 May 2021)
2.2 – CiteScoreTracker 2021 (Last updated on 6 March 2022)
Submit a manuscript to GaBI Journal
Scientific, legal and regulatory challenges facing biosimilars development
LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.
View this week’s headline article: Nomenclatura de biológicos y biosimilares en Argentina
Browse the news in the Latin American Forum!
Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
LATIN AMERICAN FORUM
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.
Vea el artículo principal de esta semana: Nomenclatura de biológicos y biosimilares en Argentina
!Explore las noticias en el Foro Latinoamericano!
Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
1. IQVIA. The Impact of Biosimilar competition in Europe. December 2021. [www.iqvia.com]. Durham, North Carolina, United States: IQVIA; [cited 2022 Mar 11]. Available from: www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2021.pdf?_=1645619624325
2. European Medicines Agency, European Commission. Biosimilars in the EU - Information guide for healthcare professionals. 2 October 2019. [www.ema.europa.eu]. Amsterdam, The Netherlands: EMA; [cited 2022 Mar 11]. Available from: www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf
3. The Finnish Medicines Agency. Interchangeability of Biosimilars – Position of Finnish Medicines Agency Fimea. 22 May 2015. [www.fimea.fi]. Kuopio, Finland: Fimea; [cited 2022 Mar 11]. Available from: www.fimea.fi/documents/542809/838272/29197_Biosimilaarien_vaihtokelpoisuus_EN.pdf
4. The Finnish Medicines Agency. Automatic substitution of biological medicines would be possible if carefully planned and gradually implemented. 10 June 2019. [www.fimea.fi]. Kuopio, Finland: Fimea; [cited 2022 Mar 11]. Available from: www.fimea.fi/web/en/-/automatic-substitution-of-biological-medicines-would-be-possible-if-carefully-planned-and-gradually-implemented
5. Danish Medicines Agency. Frequently asked questions about biological and biosimilar medicinal products. 29 January 2016. [www.laegemiddelstyrelsen.dk]. Copenhagen, Denmark: Laegemiddelstyrelsen; [cited 2022 Mar 11]. Available from: www.laegemiddelstyrelsen.dk/en/sideeffects/biological-and-biosimilar-medicinal-products/frequently-asked-questions
6. Health Products Regulatory Authority (HPRA). Guide to Biosimilars for Healthcare Professionals. 5 August 2020. [www.hpra.ie]. Dublin, Ireland: HPRA; [cited 2022 Mar 11]. Available from: www.hpra.ie/docs/default-source/publications-forms/guidance-documents/guide-to-biosimilars-for-healthcare-professionals-v3.pdf?sfvrsn=27
7. Federal Agency for Medicines and Health Products. Biosimilars. 16 December 2020. [www.hpra.ie]. Brussels, Belgium: HPRA; [cited 2022 Mar 11]. Available from: www.famhp.be/en/human_use/medicines/medicines/MA_procedures/types/Biosimilars
8. Sarnola K, Merikoski M, Jyrkkä J, Hämeen-Anttila K. Physicians’ perceptions of the uptake of biosimilars: a systematic review. BMJ Open. 2020;10(5):e034183.
9. Teeple A, Ellis LA, Huff L, et al. Physician attitudes about non-medical switching to biosimilars: results from an online physician survey in the United States. Curr Med Res Opin. 2019;35(4):611 7.
10. O’Callaghan J, Bermingham M, Leonard M, et al. Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland. Regul Toxicol Pharmacol. 2017;88:252 61.
11. Overbeeke E, De Beleyr B, de Hoon J, Westhovens R, Huys I. Perception of originator biologics and biosimilars: a survey among Belgian rheumatoid arthritis patients and rheumatologists. BioDrugs. 2017;31(5):447 59.
12. Chapman SR, Fitzpatrick RW, Aladul MI. Knowledge, attitude and practice of healthcare professionals towards infliximab and insulin glargine biosimilars: result of a UK web-based survey. BMJ Open. 2017;7(6):e016730.
13. Druedahl LC, Kälvemark Sporrong S, Minssen T, et al. Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution. PLoS One. 2022;17(1):e0262537.
14. European Commission. Pharmaceutical Strategy for Europe. 25 November 2020. [www.eurlex.europa.eu]. Brussels, Belgium: Eur-Lex; [cited 2022 Mar 11]. Available from: www.eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020DC0761
15. European Medicines Agency. EMA Regulatory Science to 2025 - Strategic reflection. EMA/110706/2020. 2020. [www.ema.europa.eu]. Amsterdam, The Netherlands: EMA; [cited 2022 Mar 11]. Available from: www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.
Post your comment