FDA accepts Mylan's BLA for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim).- Mylan + Biocon Ltd
Mylan N.V. and Biocon Ltd. announced that the FDA has accepted Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim), for filing through the 351(k) pathway.The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer. The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is 9 October, 2017.
Comment: Amgen has sued Apotex claiming infringement of two patents, one of which expired in October 2015. A court upheld the validity of the other patent, No. 8,952,138, in a July ruling. That patent, which expires in 2031, covers improved redox chemistry-based methodologies for efficiently refolding cysteine-containing proteins expressed in non-mammalian cells at high protein concentrations.
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