BioPharm International - October 2021

BioPharm-October 2021-Regulatory-Sourcebook

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14 BioPharm International eBook October 2021 The Evolving Biosimilar Approach The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market. E urope has the most mature biosimilar market in the world, with the European Medicines Agency (EMA) approving the first biosimilar medicine in 2006 (1). Since the first biosimilar approval, and as correct at the time of writing, the region now has 69 biosimilars approved for use, excluding products that have been withdrawn after approval, before approval, or for applications that were refused by EMA (2). Market research shows the biosimilar landscape in Europe is set to continue expansion with double digit compound annual growth rate of 22.1% expected between 2021 and 2026 (3). Key driver for this growth includes the loss of pat- ent protection for several blockbuster biologics in Europe, which will lead to increased competition in the market. "It is widely accepted that the EU has led the way in terms of the development of a biosimilar approval frame- work, with the European market expected to develop fur- ther in the years ahead as patents for biologic products continue to expire," says David Lancaster, life sciences part- ner, Pinsent Masons. REGULATORY EVOLUTION The European Union (EU) was the first region to set out a political and licensed framework for biosimilar approvals (4). "The EU is indeed the first region to have defined regu- lations for biosimilars, in place since 2004," says Gabriela Marton, regulatory affairs and quality director, Arriello. "This activity has served as a pillar for other authorities as they too develop local frameworks or look to fast-track regis- tration of biosimilars in their regions." However, Marton continues, simply having legislation in place will not ensure that products in development will gain market access. "For this reason, EMA and the Heads of Medicines Agencies (CMDh) have worked hard to pro- FELICITY THOMAS Regulatory Sourcebook Biosimilars Christoph Burgstedt -

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