FDA Issues CRL to Mylan and Biocon's Neulasta Biosimilar

The FDA issued a complete response letter to Mylan and Biocon for their proposed biosimilar for pegfilgrastim, also known as Amgen's Neulasta.

According to Biocon, the CRL relates to the pending update of the jointly developed BLA with certain data related to facility requalification following recent plant modifications.

The letter did not raise any questions regarding biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity, Biocon said.

The company does not expect the rejection to impact the commercial launch timing of the biosimilar in the U.S. Biocon said it is planning to work with the FDA  to resolve the issues.