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The European Medicines Agency (EMA) declares: Biosimilar swaps are coming!

 Last Update: 2022-10-01
 Source: Internet
 Author: User

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On 19 September, experts from the EU Biosimilars Working Group (BMWP) and Heads of Pharmaceutical Agencies (HMAs) drafted a joint statement confirming that biosimilars are approved by the European Union (EU) and are interchangeable with their reference formulations or equivalents, which have been endorsed by
the Committee on Pharmaceuticals for Human Use (CHMP) and the Working Group on Biologics (BWP).

The joint statement states that a biosimilar approved by the EU is interchangeable, which means that the biosimilar can be used in place of its reference formulation, or that a biosimilar can be substituted
for another biosimilar of the same reference formulation.

May be used in place of its reference formulation, or a biosimilar may be replaced
by another biosimilar of the same reference formulation.

Several EU member states have already begun to implement the interchange of biosimilars, and this joint statement clarifies the EU's position to help more patients access biodrugs
within the EU.

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