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Current Market and Regulatory Landscape of Biosimilars
Valkal Bhatt, PharmD
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Current Market and Regulatory Landscape of Biosimilars

Valkal Bhatt, PharmD
Physician incentives, through pricing and reimbursement, are another key driver of biosimilar uptake in the EU member states. In 2016, France introduced a new measure, rémunération sur objectifs de santé publique (remuneration of public health goals), encouraging physicians to prescribe a minimum of 20% insulin glargine biosimilars.33 Belgium advocates a union of the pharmaceutical industry, government, and medical sector with the goal of ensuring patient access to use of biosimilars via “Pact of the future” for the patient with the pharmaceutical industry.32 Germany encourages patient access via regionally based quotas for biosimilar prescriptions.32 In Austria and Belgium, there is an incentive for physicians to prescribe biosimilars based on cost-efficiency initiatives.

Although it is difficult to ascertain a quantitative view of the use of biosimilars in the European Union, in general they are accepted and integrated into respective healthcare systems. Funding and various methods to incentivize biosimilar use have been adopted on a national level within the European Union, perhaps indicating growing trust in biosimilars.34


Incorporation of biosimilars into the US healthcare system will require a multifaceted approach targeting provider/patient education, assurance of strict regulatory standards, and financial incentives. Biosimilar development, regulation, and clinical use are very different from those of generic synthetic drugs, perhaps contributing to the hesitancy to accept biosimilars and general unfamiliarity with key concepts. Similar concerns occurred during incorporation of biosimilars in EU healthcare systems.29 Education targeting HCPs regarding variability within biosimilars/biologics, immunogenicity, and interchangeability may aid scientific understanding of the products and instill confidence in regulatory processes. Viewing the successes seen in the European Union, a consensus of information provided jointly by manufacturers of biologics and biosimilars as well as transparency of FDA approval decisions could prove very impactful in the United States. As the evidence used for FDA approval of biosimilars is of principally analytical rather than of clinical nature, postmarket surveillance will be of mounting importance to facilitating evidence-based decisions of providers.12 Although there are challenges to the adoption of biosimilars in the United States, there is great promise of market growth and patient access to care through cooperative educational, legal, and economic initiatives. 

Author affiliation: Clinical Oncology Pharmacy Specialist, Department of Pharmacy, Memorial Sloan Kettering Cancer Center, New York, NY.
Funding source: This activity is supported by educational funding provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Author disclosure: Dr Bhatt has no relevant financial relationships with commercial interests to disclose.
Authorship information: Drafting of the manuscript, supervision, manuscript review.
Address correspondence to:
Medical writing and editorial support provided by: James M. Seternus Jr, DO; and Alex Ganetsky, PharmD. At the time the support was provided, Dr Ganetsky was a clinical pharmacy specialist at the Hospital of the University of Pennsylvania.
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