Mylan, Biocon Get CRL for Manufacturing for Biosimilar of Amgen’s Neulasta
The US Food and Drug Administration has issued a Complete Response Letter (CRL) to Mylan and Biocon, a Bangalore, India-based pharmaceutical company, for their biologics license application (BLA) for MYL-1401H, a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim), a drug to stimulate white-blood cell production after chemotherapy. Neulasta had 2016 global sales of $3.9 billion.
The CRL relates to the pending update of the BLA with certain chemistry, manufacturing, and controls data from facility requalification activities post recent plant modifications. The CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data, or immunogenicity.
MYL-1401H is a part of the biosimilars portfolio being developed jointly by Mylan and Biocon. Biocon is partnered with Mylan for the development, manufacturing, supply, and commercialization of up to six proposed biosimilars, which includes trastuzumab, pegfilgrastim, and insulin analogs. Trastuzumab is the active ingredient in the reference product, Roche’s Herceptin, a drug for treating HER2-positive breast and gastric cancers. It had 2016 global sales of CHF 6.78 billion ($7.03 billion). Pegfilgrastim is the active ingredient in Amgen’s Neulasta, a leukocyte factor for treating neutropenia, or low white blood cell count, in patients with certain types of non-myeloid cancers. Neulasta is one of Amgen’s top-selling drugs with 2016 sales of $3.9 billion. The companies are also developing a biosimilar of Sanofi’s Lantus (insulin glargine), which had 2016 sales of EUR 5.71 billion ($6.54 billion).
Biocon said it does not expect the CRL to impact the time of commercial launch for the product.