R&D Industry Finds Biosimilar Interchangeability Statement By EU Regulators ‘Concerning’

A joint statement from the European Medicines Agency and Heads of Medicines Agencies on biosimilar interchangeability is “concerning,” says Europe’s R&D-based industry federation, EFPIA.

Interchangeable
Biosimilars and reference products are interchangeable, say the EMA and HMA • Source: Shutterstock

A statement from the European Medicines Agency and the EU’s Heads of Medicines Agencies asserting that approved biosimilars and their reference products are interchangeable is concerning, says EFPIA, Europe’s R&D-based pharmaceutical industry lobby group. Although it will have no immediate impact, the statement could influence policies in the EU member states, which have different approaches when it comes to switching such products, say lawyers.

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