Trastuzumab approval is a milestone: Biocon

Trastuzumab approval is a milestone: Biocon

Mylan and Biocon announced that US Food and Drug Administration (FDA) have approved Mylan's Ogivri, a biosimilar to Herceptin, co-developed with Biocon. The FDA has approved a biosimilar to Herceptin, termed Ogivri, which is utilized for the treatment of breast and stomach cancers that overexpress the HER2 gene.

FDA then issued a Form 483 at the Bengaluru site and the target action date for FDA approval was pushed back to December, but Biocon and Mylan said the delay would not impact commercialization. Companies making a biosimilar - Mylan and Biocon, in the case of Ogivri - can do so when the patent to the original product expires.

Ogivri's clearance is based on a review of evidence that included extensive structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates its biosimilarity to Herceptin (trastuzumab).

We expect Biocon's share of profit to be significant and also expect a large contribution from biosimilars going ahead, said Mazumdar Shaw.

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Meanwhile, in the EU, Mylan withdrew its application for the Herceptin biosimilar, though just yesterday, the companies said that the European Medicines Agency has since re-accepted its application.

"This approval represents a landmark achievement for the Biocon-Mylan collaboration and is an important endorsement of our development and manufacturing capabilities in the area of monoclonal antibodies", said Arun Chandavarkar, chief executive officer and joint managing director of Biocon.

"It will allow us to bring this important biosimilar - the first of its kind - to market in the USA, expanding cancer-patient access to more affordable treatment".

First approved in the U.S. in 1998, Herceptin had USA sales of more than $2 billion for the 12 months ending 30 September 2017, according to IQVIA.

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