Biocon confident of resolving issues with USFDA over biosimilar ‘pegfilgrastim’

While the company is set to launch proposed biosimilar, Pegfilgrastim in the United States market, the US Food and Drug Administration has issued Complete Response Letter (CRL) to it seeking more data on the cancer drug


Bengaluru: The U.S. Food and Drug Administration (US-FDA) has issued a Complete Response Letter (CRL) for Mylan´s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar pegfilgrastim.

Pegfilgrastim is a biosimilar of Amgen’s chemotherapy drug Neulasta. This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan. It is one of the six biologic products co-developed by the companies, as part of an exclusive partnership.

Meanwhile, its reaction to the USFDA’s letter seeking more data, the Biocon mentioned that the CRL relates to the pending update of the BLA with certain CMC 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,” it said.

The company appears to be confident of submitting the required data on time so that the launch of the product doesn’t get delayed.

“We do not expect this CRL to impact the commercial launch timing of biosimilar pegfilgrastim in the US. We are committed to working with the agency to resolve the issues stated in the CRL,” read the statement from Biocon.