Biocon’s Bengaluru Biosimilars Plant Cleared For EU
Company Expands Production Capacity For Pegfilgrastim And Trastuzumab
Biocon is actively expanding its biosimilars manufacturing capacity with an aim to further penetrate EU markets after receiving a GMP approval for a key manufacturing site. The company has ramped up production for trastuzumab and pegfilgrastim, while awaiting approval for bevacizumab.
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The May meeting of the European Medicines Agency’s drug evaluation committee, the CHMP, is under way. Decisions are due on whether eight marketing approval applications should be approved for marketing in the EU.
Despite having biosimilars of insulin glargine and etanercept that are expected to launch in the US and Europe respectively midway through this year, a biosimilar bevacizumab candidate filed in both regions, an in-development Botox rival still being considered and several other biosimilars already on the market around the world, Mylan insists that its biosimilars journey is just beginning.
Biocon has reported FDA clearance for its Malaysian insulin facility, while Lupin and Xellia have also received plant approvals. Meanwhile, Alembic has seen mixed fortunes, receiving both Form 483 observations and an EIR.