Health Care

FDA Okays First Biosimilar For Treatment Of Certain Breast And Stomach Cancers

FDA Okays First Biosimilar For Treatment Of Certain Breast And Stomach Cancers

In a big positive for Biocon and a huge milestone for Indian pharma companies, the US Food and Drug Administration (US FDA) has approved cancer drug Trastuzumab used to treat breast and metastatic stomach cancer.

Biocon rose 15%, closing at Rs 514, and the USFDA development sparked a revision of target price for its shares across brokerages.

A biosimilar is a almost identical but lower-priced version of the treatment on which it is based. Citi said Biocon is most leveraged among its Indian peers to global biosimilar and should deliver meaningful upside over the long term.

"The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs", Commissioner Scott Gottlieb said. Companies making a biosimilar - Mylan and Biocon, in the case of Ogivri - can do so when the patent to the original product expires.

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The FDA's approval of Ogivri 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 Ogivri is biosimilar to Herceptin.

Mylan has become the first pharma company to win USA approval for a biosimilar of Roche's big-selling cancer antibody Herceptin. After this review, Ogivri was approved as a biosimilar and not as an interchangeable product.

Like Herceptin, the labeling for Ogivri (trastuzumab-dkst) contains a Boxed Warning to alert healthcare professionals and patients on increased risks of heart disease, infusions reactions, lung damage and harm to a developing fetus.

Mylan and Biocon already have approval for the Herceptin biosimilar in more than a dozen countries around the world, including India, and have also submitted their version for approval in Europe, Canada and Australia, among other markets.