The agency issued a ‘complete response letter’. Such letters are issued when an FDA review an FDA review finds that an application for a new drug cannot be approved ‘in its present form’.
The clarifications were related to its manufacturing facility.
The FDA sought “CMC (Chemistry, Manufacturing and Controls) data from facility requalification activities post recent plant modifications,” Biocon said.
The regulator’s response related to Mylan’s request for approval of MYL-1401H as a biosimilar for pegfilgrastim, which is used to stimulate the production of white blood cells in chemotherapy patients.
The product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan.
Biocon said FDA’s questions did not address the efficacy or safety of the drug, and that it expects the compound to be launched in time.
“The CRL (letter) did not raise any questions on biosimilarity, pharmacokinetic or pharmacodynamic data, clinical data or immunogenicity,” it said.
“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 expeditiously,” it added.
Biosimilars are drugs that are “highly similar” to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.
Biological products, or biologics, are medical products. Many biologics are made from a variety of natural sources (human, animal or microorganism). Like drugs, some biologics are intended to treat diseases and medical conditions.