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Mylan, Biocon's biosimilar of Amgen's Neulasta rejected by US FDA


According to Market Intelligence, December 2022


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Mylan, Biocon's biosimilar of Amgen's Neulasta rejected by US FDA

Mylan NV and Biocon Ltd.'s biosimilar of Amgen Inc.'s Neulasta failed to win the approval of the U.S. Food and Drug Administration, which is seeking information on a manufacturing facility.

Neulasta fights infections in cancer patients by helping the growth of new white blood cells.

The agency issued a complete response letter for the biologics license application for MYL-1401H, which is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan.

Biocon said the letter relates to a pending update of the application with certain manufacturing-related data from requalification activities after modifications at the facility. The letter did not raise any questions on biosimilarity, clinical data or immunogenicity.

The company does not expect the complete response letter to impact the commercial launch timing of the drug in the U.S. and said it was committed to working with the FDA to resolve the issues.

According to FiercePharma, the regulator criticized company's Bangalore plant in a Form 483. The form was issued after an inspection found problems across entire range of processes at the facility.

In August, Biocon pulled its European marketing applications for proposed biosimilar versions of Roche Holding AG's breast cancer drug Herceptin and Amgen's Neulasta.