Stocks

Biocon soars over 7% as USFDA issues CRL for proposed biosimilar

Our Bureau Chennai | Updated on January 08, 2018 Published on October 10, 2017

Biocon shares jumped over 7 per cent on Tuesday as the USFDA has issued a complete response letter for Mylan's biologics licence application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim, indicated for use in the treatment of cancer.

The company, however said it does not expect this CRL to impact the commercial launch timing of biosimilar Pegfilgrastim in the US. This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan.

The company shares ended higher by 7.24 per cent at Rs 368.75 on the BSE. On the NSE, the stock closed up by 7.09 per cent at Rs 368.60.

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 Food and Drug Administration has issued a complete response letter (CRL) for Mylan’s biologics license application (BLA) for MYL-1401H, a proposed biosimilar pegfilgrastim,” Biocon said in a regulatory filing.

It further said: “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.''

“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,” the company added.

Published on October 10, 2017
null
This article is closed for comments.
Please Email the Editor