FDA rebuff not expected to delay Neulasta biosimilar launch

India’s Biocon and Netherlands-incorporated Mylan have suffered a setback in their bid for US FDA approval for MYL-1401H, the firms’ jointly-developed Neulasta (pegfilgrastim) biosimilar.

The US Food and Drug Administration issued a complete response letter (CRL), citing a need for: “Data from facility requalification activities,” following recent modifications to a manufacturing plant.

Biocon said: “The CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity.”

“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.”