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FDA approves first biosimilar for treatment of certain breast, stomach cancers

05 December 2017
FDA approves first biosimilar for treatment of certain breast, stomach cancers

Shares of Biocon today surged as much as 14 per cent in morning trade after the biotechnology major said it has received regulatory approval to market a biosimilar of cancer drug Herceptin in the United States.

The drug, co-developed by U.S. drug maker Mylan, is the first biosimilar Trastuzumab to get a marketing approval in United States markets. Companies making a biosimilar - Mylan and Biocon, in the case of Ogivri - can do so when the patent to the original product expires. 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.

To gain approval, the FDA reviewed evidence of Ogivri including: animal study data, structural and functional characterization, pharmacokinetic and pharmacodynamics data and clinical safety data. "We're committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs".

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's biosimilar for Herceptin is also under review by regulatory authorities in Australia, Canada, Europe and several additional markets, the statement said.

Mylan CEO Heather Bresch said: "The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the United States healthcare system".

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