Leveraging the holistic benefits of biosimilars in Europe – part 2: how payers can safeguard the future of a healthy biosimilar market environment

ABSTRACT

Introduction

Biosimilars have improved access to biologic medicines; however, historical thinking may jeopardize the viability of future markets.

Areas covered

An expert panel of eight diverse European stakeholders provided insights about rethinking biosimilars and cost-savings, reducing patient access inequalities, increasing inter-market equity, and improving education. The insights reported here (Part 2) follow a study that provides perspectives on leveraging the holistic benefits of biosimilars for market sustainability based on independent survey results and telephone interviews of stakeholders from diverse biosimilar markets (Part 1). Directional recommendations are provided for payers.

Expert Opinion

The panel’s market maturity framework for biosimilars has three stages: ‘Invest,’ ‘Expand’ and ‘Harvest.’ Across market stages, re-thinking the benefits of biosimilars beyond cost-savings, considering earlier or expanded access/new indications, product innovations, and re-investment of biosimilar-generated cost-savings should be communicated to stakeholders to promote further engagement. During ‘Expand’ and ‘Harvest’ stages, development of efficient, forward-looking procurement systems and mechanisms that drive uptake and stabilize competition between manufacturers are key. Future biosimilars will target various therapy areas beyond those targeted by existing biosimilars. To ensure a healthy, accessible future market, stakeholders must align their objectives, communicate, collaborate, and coordinate via education, incentivization, and procurement, to maximize the totality of benefits.

KEYWORDS:

• Biosimilar
• Europe
• health technology assessment
• market access
• payer
• value

Article highlights

• Biologics can improve the management of chronic and/or life-threatening diseases; however, access to biologics is variable, which means that not all patients have benefited from the improved outcomes and affordability of biologics.

• Biosimilars are generally more affordable than biologics, providing healthcare systems with lower-cost alternatives to biologics with which to treat patients. However, despite the cost-savings, the future of the biosimilars market is not guaranteed and payers bear a large responsibility for its sustainability.

• There is no ‘one-size-fits all’ framework to maximize capturing biosimilar generated benefits. Policy and investment decisions must be made based on specific aspirations of the country’s key stakeholders (alignment of their respective interests) and the ‘maturity’ of their biosimilar market and usage of the specific biologic.

• Along with the importance of implementing procurement policies that generate price reductions, a stable competitive market environment for the future is needed.

• Payers should examine the current procurement systems and mechanisms used to drive uptake and determine whether they are appropriate for generating stable future competition between manufacturers, particularly for the ‘next wave’ of biosimilars for rare diseases.

• For the next major period of loss of exclusivity for biologic products (2025‒2030), there is a need for procurement systems that will generate stable competition and cost-savings; that is, investment in procurement contracts beyond year-end so the system can respond to market dynamics, potentially increasing the likelihood of long-term gains.

Compliance with ethical standards

Ethical approval was not applicable to this work as it was based on previously reported results from Part 1 [6]. Research in Part 1 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 not applicable to this paper as it is a prospective report that makes recommendations for the future based on the biosimilar market maturity framework that was introduced in Part 1.

Data availability statement

Not applicable.

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, EliLilly, 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 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; and 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, EliLilly, 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, and Vifor Pharma; and lecture fees from Abbvie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer, and 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.

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 Latymer 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.

Supplementary Material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14737167.2024.2310684

Additional information

Funding

This work was supported by Pfizer.