U.S. FDA accepts Biologics License Application for Mylan | Pharma Magazine

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U.S. FDA accepts Biologics License Application for Mylan

Biocon Ltd announced that the U.S.Food and Drug Administration has accepted Mylan’s biologics license application for MYL- 1401O.

Dr Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said,”This is a major milestone for the Mylan and Biocon collaboration and this development positions both the companies to be able to address the need of U.S. patients for a high-quality biosimilar to treat certain HER2-positive breast cancers, in the near future.”

“The FDA acceptance marks an important step toward increasing access to this treatment option for patients in the U.S and are are committed to bringing this product to market and look forward to working with FDA over the next months, says Mylan President Rajiv Malik.

If approved, MYL-1401O has potential to be the first Biosimilar Trastuzumab in the U.S.

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