Biocon surgest 15% on USFDA approval

Mylan and Biocon are among a host of biosim developers that are working to grab a piece of Roche’s global cancer fortunes

Biocon surged 14% to Rs 510, also its all-time high on the BSE in early morning trade, after the company said it has secured a regulatory approval to market a biosimilar for anti- cancer drug Herceptin in the US.

The biosimilar - developed by Mylan and Biocon and called Ogivri (trastuzumab-dkst) - has been approved by the FDA for HER2-positive breast or metastatic stomach cancer, the same indications as Herceptin which brought in nearly $7bn in sales previous year, around $2.5bn of that total from the U.S. market. Mylan and Biocon's biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India. Mylan is a global leader in the development and manufacturing of complex products, including biosimilar medicines, with a portfolio of 16 biosimilar and insulin analog products.

Scott Gottlieb, FDA Commissioner (MD, USA), concluded: "The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs".

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).

After this review, Ogivri was approved as a biosimilar and not as an interchangeable product.

But Ogivri also shares Herceptin's side effects, which can include heart disease (cardiomyopathy), infusion reactions, and lung damage, and it may also harm a developing fetus.

"We are extremely pleased with the acceptance of our [marketing authorization application in Europe]", Rajiv Malik, Mylan's president, said in a press release.

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