Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), has been accepted by the U.S. Food and Drug Administration.
"We're proud of the FDA acceptance of our BLA for proposed biosimilar pegfilgrastim,” Mylan President Rajiv Malik said in a statement. “This is the second BLA accepted for review by FDA as part of the Mylan and Biocon partnership within the past two months. The milestone builds upon the acceptance of regulatory filings for proposed biosimilar pegfilgrastim in Europe, Australia and Canada and reinforces our dedication and commitment to establishing a global platform for this product.”
Malik noted that, once approved, the proposed drug will add to the company’s expansive oncology portfolio that delivers affordable treatment options for various cancers.
"We are extremely pleased with the regulatory progress of our biosimilars in the U.S. The FDA's acceptance for review of our second BLA for a proposed biosimilar developed by Biocon and Mylan is an outcome of our strong R&D and manufacturing capabilities,” Dr. Arun Chandavarkar, CEO and joint managing director of Biocon, said. “Once approved, our proposed biosimilar pegfilgrastim will provide a high quality alternative to branded pegfilgrastim (Neulasta) for cancer patients during cytotoxic chemotherapy. It will expand our oncology portfolio and further enable us to fulfil our promise of making cancer-care affordable and accessible for patients across the globe."
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