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FDA Issues Complete Response Letter for Pegfilgrastim Biosimilar

Jason Harris
Published: Tuesday, Oct 10, 2017

Biocon has announced that the FDA has issued a complete response letter (CRL) for Mylan’s biologics License Application (BLA) for MYL-1401H, a proposed biosimilar for Amgen’s pegfilgrastim (Neulasta).

In June, the agency issued a CRL for a BLA for CHS-1701, a pegfilgrastim biosimilar from Coherus BioSciences, requesting a reanalysis of a subset of subject samples with a revised immunogenicity assay and additional information on the manufacturing process.
Waller CF, Blakeley C, Pennella E. Phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H vs EU-neulasta® in the prophylaxis of chemotherapy-induced neutropenia. Ann Oncol. 2016;27(suppl_6):1433O.

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