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Biocon withdraws application for trastuzumab biosimilar from EMA

Read time: 1 mins
Last updated: 19th Aug 2017
Published: 19th Aug 2017
Source: Pharmawand

The European Medicines Agency has found issues with the Biocon product plant in Bangalore. It told Mylan and Biocon that a follow-up inspection would be in order before the trastuzumab biosimilar and a biosimilar of Amgen�s Neulasta will be considered for approval .Biocon Ltd. said it will withdraw its application for EU approval of its biosimilar version of Roche's blockbuster cancer drug Herceptin, after the European Medicines Agency informed the company it would need to re-inspect a drug product facility.

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