Mylan and Biocon’s new biosimilar trastuzumab accepted for EU review

Mylan and Biocon have announced that their proposed biosimilar version of trastuzumab has been accepted for European regulatory review.

The European Medicines Agency has accepted Mylan's marketing authorisation application for the new biosimilar, which is intended for use in the treatment of certain HER2-positive breast and gastric cancers

Analytical, functional and pre-clinical data was used to support the application, as well as results from pharmacokinetics and confirmatory efficacy and safety trials showing the drug's bioequivalence to the reference product.

This is the second biosimilar submission developed by Mylan and Biocon to be accepted for review in Europe, following the validation of their application for a proposed biosimilar version of pegfilgrastim last month.

Rajiv Malik, president of Mylan, said: "Europe represents a key market for more affordable versions of these important products, as governments across the region strive to reduce healthcare costs."

Trastuzumab is one of six biologic products being co-developed by Mylan and Biocon for the global marketplace.

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