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Biocon and Mylan’s pegfilgrastim is a biosimilar of Amgen’s chemotherapy drug Neulasta. Photo: Hemant Mishra/Mint (Hemant Mishra/Mint)
Biocon and Mylan’s pegfilgrastim is a biosimilar of Amgen’s chemotherapy drug Neulasta. Photo: Hemant Mishra/Mint (Hemant Mishra/Mint)

USFDA seeks more data on Biocon-Mylan’s biosimilar

USFDA issues complete response letter for Biocon and Mylan’s application for biosimilar pegfilgrastim seeking certain data before the product gets an approval

Mumbai: The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Biocon Ltd and Mylan N.V.’s application for biosimilar pegfilgrastim seeking certain data before the product gets an approval.

Biocon and Mylan’s pegfilgrastim is a biosimilar of Amgen’s chemotherapy drug Neulasta. It is one of the six biologic products co-developed by the companies, as part of an exclusive partnership.

The US FDA issues complete response letters to communicate to a company that its application to market a drug will not be approved in its present form.

In the CRL, the regulator has sought certain data on chemistry, manufacturing and controls from facility requalification activities post recent plant modifications, Biocon said in an exchange filing on Tuesday.

“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," Biocon said.

On Tuesday, shares of Biocon closed at Rs368.75, up 7.24%, on the BSE, while benchmark Sensex index rose 0.24% to close at 31,924.41 points.

On 31 August, the US FDA had extended target action date for Biocon and Mylan’s biosimilar trastuzumab application to 3 December in order to review some information submitted to the agency. Target action dates are the FDA’s internal deadlines for action on all applications.

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