Proposed policies to maximize societal benefit of biosimilars

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During the European Commission’s (EC) fifth workshop on biosimilars, which was held in Brussels, Belgium on 30 October 2019, the subject of what policies might maximize the benefit of biosimilars to societies across Europe was discussed [1].


In his presentation, Zoltán Kaló, Professor of Health Economics at the Center for Health Technology Assessment, Semmelweis University and the Syreon Research Institute, gave a list of proposed policies that might maximize the societal benefit of biosimilars.

These policies were grouped into regulatory and public administration of biosimilars, clinical guidelines, financing protocols and managed care, and patient education. The policies proposed by Professor Kaló included:

Regulatory and public administration of biosimilars
• Expedited price and reimbursement process to facilitate timely market entry
• Administrative tools and policy measures to incentivize use of more affordable biosimilars
• Acceptance of international data generated in other EU Member States based on existing or new information exchange platform among regulators

Clinical guidelines, financing protocols and managed care
• Amendment of clinical guidelines to allow earlier or extended use of more affordable biologicals, if health benefit is proven for the new patient population
• Multisource biologicals should be first-line biological therapy for all patients. More expensive patented biologicals with no proven significant clinical benefit compared to biosimilars should only be second-line options
• Single switch of patients from originator biological to more affordable biosimilar alternative under medical supervision should be mandated after patent expiry
• No separate reimbursement categories for: 1) biosimilars; and 2) originator biological or its modified formulation, e.g. subcutaneous vs intravenous, unless the modified formulation has proven benefits to patients or healthcare payers

Patient education
• Physicians should not only be informed about scientific evidence on biosimilars but also given guidance on how to appropriately educate their patients on these medicines

Professor Kaló concluded that, as well as the policies proposed above, national targets are needed in order to optimize the benefits of biosimilars for society.

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1. European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. Multi-stakeholder workshop on biosimilar medicinal products; 30 October 2019; Brussels, Belgium.

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