Mylan Pharma has received USFDA approval for its biologics licence application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim. The proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. The milestone builds on the acceptance of regulatory filings for proposed biosimilar Pegfilgrastim in Europe, Australia and Canada. Once approved, proposed biosimilar Pegfilgrastim will complement Mylan’s broad oncology portfolio focused on expanding access to more affordable treatments for multiple types of cancer. The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is October 9, 2017. Once approved, the proposed biosimilar Pegfilgrastim will provide a high quality alternative to branded Pegfilgrastim (Neulasta) for cancer patients during cytotoxic chemotherapy. It may be noted, Biocon has co-exclusive commercialisation rights with Mylan for the product in the rest of the world.
Company Profile : Mylan Pharmaceuticals Pvt Ltd
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