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Biosimilars: the challenges to bring a “new” concept to market A short review of the first decade of biosimilars

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Paul Cornes
Consultant Oncologist
Comparative Outcomes Group
Bristol, United Kingdom

Michael Muenzberg
Vice President, Director Medical Affairs Biosimilars Ares Trading S.A.
Comparative Outcomes Group
Aubonne, Switzerland

Biosimilars have had marketing approval in Europe for a decade. Despite initial concerns that such a class of drugs carried inherent risks to patients – these 10 years have been a medical success. All EMA approved biosimilars have been found equally safe and effective as their reference products.

The clear pharmaceutical and clinical success of biosimilars over the decade stands in stark contrast to their commercial performance. Uptake within Europe has varied between 2 and 100%. No other class of drug shows such striking variation. Understanding why such a scientific success can be such a commercial worry is important both to manufacturers and health system payers. The failure to create a functioning global biosimilars market will starve investment needed for next generation