Capturing the holistic value of biosimilars in Europe – part 1: a historical perspective

ABSTRACT

Introduction

Approved biosimilars exhibit comparable efficacy, safety, and immunogenicity to reference products. This report provides perspectives on the societal value of biosimilars within Europe and potential factors that have influenced market dynamics.

Methods

An independent, self-administered survey or one-on-one in-depth interview was used to collect viewpoints about the impact of biosimilar medicines within European markets. Key insights were also sought from an expert panel of European stakeholders.

Results

Survey respondents were clinicians, pharmacists, and payers from Europe (N = 103). Perceived benefits of biosimilars included increased access to innovative medicines (73% of respondents) or biologic treatments (66%). Biosimilar competition was thought to expand access to biologics (~50% of respondents) or drug combinations (~36%) and reduce biologic access time (34%). Key drivers of biologic access after biosimilar competition included increased biologic awareness (51%) and changes to prescribing guidelines (37%) and/or treatment paradigms (28%). The expert panel developed a market maturity framework of biosimilar adoption/opportunities comprising three stages: ‘Invest,’ ‘Expand,’ and ‘Harvest.’ Findings were supported by published literature.

Conclusions

In Europe, the perceptions of well-informed survey/interview respondents are that biosimilars have improved patient outcomes via increased access to biologics and innovative biologic products, contributing to earlier and longer treatment of a broader population.

KEYWORDS:

• Biosimilar
• drug benefits
• Europe
• medicines policy
• quality of care
• reimbursement

Article highlights

• Biologics have transformed patient outcomes across a wide range of therapeutic areas; however, the high price of biologics can create barriers to access for patients.

• Biosimilars are highly similar in structure and clinically equivalent in biological function, efficacy, safety, and immunogenicity to licensed (i.e. reference or originator) biologic products.

• Using insights gathered from a survey, interviews, and experts in the field, as well as from a review of published literature, this manuscript (Part 1 of 2) provides perspectives on the societal value of biosimilars within Europe and potential factors that have influenced market dynamics.

• Findings from the survey and literature review provide evidence that biosimilars have generated significant cost-savings and can deliver a wide range of benefits to healthcare systems and society.

• Findings also demonstrate that access to biologics in Europe has improved in part due to biosimilar competition and this may allow earlier and longer treatment of a broader population.

• An expert panel describes a market maturity framework for the adoption of biosimilars comprising three stages (‘Invest,’ ‘Expand,’ and ‘Harvest’) that broadly correlate to the level of access to biologics within a therapy area and that could be used to maximize biosimilar-generated benefits.

Compliance with ethical standards

This research was considered exempt from institutional research board review because it involved survey procedures and was conducted according to the following codes of conduct: BHBIA/MRS/ESOMAR/Data Protection Act. Informed consent was obtained either online electronically or verbally only during telephone interviews.

Data availability statement

All original data are contained within Figure 1 or in the article text.

Declaration of interest

J Mestre-Ferrandiz declares an honorarium received from Pfizer for participation in the expert panel in support of the preparatory work upon which this manuscript is based.

M Czech declares a consulting/advisory role in AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Biogen, Eli Lilly, GSK, Janssen, MSD, Novartis, Pfizer, Sanofi, Takeda and UCB.

J S Smolen has received grants for his institution from AbbVie, AstraZeneca, Janssen, Lilly, Novartis, and Roche, and has received honoraria for consulting or speaking engagements from AbbVie, Amgen, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Lilly, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, and UCB.

P Cornes declares honoraria or support for attending meetings from Accord Healthcare, Amgen, Astro Pharma, European Association for Hospital Pharmacists, European Commission, Medicines for Europe/European Generics Association, Medscape, Mylan, Napp, Pfizer/Hospira, Sandoz and Teva.

M S Aapro declares a consulting/advisory role in Amgen, BMS, Daiichi Sankyo, Fresenius Kabi, G1 Therapeutics, Genomic Health, Helsinn Healthcare, Merck, Merck KGaA, Novartis, Pfizer, Pierre Fabre, Roche, Sandoz, Tesaro, and Vifor Pharma; speakers’ bureau at Accord Research, Amgen, Biocon, Dr Reed, Genomic Health, Helsinn Healthcare, Mundipharma, Novartis, Pfizer, Pierre Fabre, Roche, Sandoz, Taiho Pharmaceutical, Tesaro, and Vifor Pharma; research funding from Helsinn Healthcare, Novartis, Pierre Fabre, and Sandoz.

S Danese declares consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, Applied Molecular Transport, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, Morphic, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, Teladoc Health, TiGenix, UCB Inc., Vial, Vifor and lecture fees from AbbVie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer, Takeda.

S Deitch was a full-time employee of Charles River Associates when the work was conducted and was contracted by Pfizer in connection with the development of the manuscript.

H Tyldsley and W Foster are full-time employees of Charles River Associates and were contracted by Pfizer in connection with the development of the manuscript.

P Shah and M Latymer are full-time employees of and hold stock and stock options in Pfizer.

A G Vulto founded the KU Leuven Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity (MABEL Fund). He is involved in consulting, advisory work and speaking engagements for Accord Healthcare, Amgen, Biogen, Effik, Fresenius/Kabi, Medicines for Europe, Mundipharma, Novartis, Pfizer/Hospira, and Sandoz.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14737167.2023.2297926

Acknowledgments

Margaret Kyle, Professor of Economics, Centre d’économie industrielle (Cerna), Mines ParisTech, and a subject-matter expert, participated on the expert panel and endorsed the final survey report. Medical writing support was provided by Sue Reinwald, PhD, and Elyse Smith, PhD, of Engage Scientific Solutions and funded by Pfizer.

Author contributions

All authors contributed to content development, writing, and critical review of the paper. M.L. is the overall guarantor. All authors have read and agreed to the published version of the manuscript.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This work was supported by Pfizer.