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Towards a Sustainable European Market for Off-Patent Biologics

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Professor Meir Pugatch spoke yesterday at the event: “Building a sustainable Policy Framework for Biologics and Biosimilar Medicines in Europe”, which took place at the European Parliament, and included members from the European Commission and organizations such as Medicines for Europe, ESMO and EPF. Professor Pugatch presented the findings of a new study by Pugatch Consilium, commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA).

With 38 biosimilar medicines approved and marketed and hundreds of clinical trials on promising biologic medicines conducted annually, Europe is a global leader in the field of biologic medicines. Yet from a policy perspective the Single Market is highly diversified. It is therefore essential to ask: “How should policy frameworks be designed and implemented to ensure long-term sustainability of off-patent biologic markets while taking into account health system financing and efficiency, in addition to commercial and patient access perspectives?”

Building on a comprehensive analysis of the biologics policy ecosystem within 15 European countries, and on the insights from an Expert Opinion survey of stakeholders from all facets of the biologics market – including patients and patient groups, healthcare professionals and government representatives – the study proposes a ‘Gold Standard’ for establishing a sustainable European market for off-patent biologic medicines.

Ma'ayan Laufer

About the Author:

Ma’ayan Laufer is a senior consultant at Pugatch Consilium - a boutique consultancy that provides evidence-based research, analysis and intelligence on the fastest growing sectors of the knowledge economy. Ma’ayan specializes in regulatory and economic analysis related to healthcare, pharmaceuticals, intellectual property and innovation. He has wide experience in benchmarking excellence in the biomedical and pharmacovigilance fields, and specific experience in mapping clinical trial, registration and pharmacovigilance environments. Ma’ayan holds an MSc in Healthcare Management & Administration from the University of Haifa.
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