US FDA approves Mylan-Biocon's biosimilar for cancer drug Herceptin

FDA Approves Eighth Biosimilar, First for Cancer Drug Herceptin

The FDA said Mylan's drug Ogivri, which was co-developed with Biocon, was the first biosimilar approved in the United States to treat breast or stomach cancer. A biosimilar is a product, derived from a living organism, that is highly similar to a product already approved by the FDA with no meaningful difference in safety, purity or potency. "This is especially important when it comes to diseases like cancer, that have a high cost burden for patients", said FDA Commissioner Scott Gottlieb.

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 is the first US/EU biosimilar approval for the partnership, allaying concerns over compliance with manufacturing standards, potentially paving the way for Biocon's biosimiliar of chemotherapy drug Neulasta in Q1 2018, according to Kotak Securities analysts. Trastuzumab-dkst was approved as a biosimilar, not as an interchangeable product. This was first ever biosimilar made by an India drug maker to get a US FDA nod.

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Biocon was the pick of the week as the company's partner Mylan got the US FDA's approval to market cancer biosimilar Trastuzumab in the US market.

Mylan said in a statement Ogivri is the first biosimilar in its collaboration with Biocon to get USA approval, and while it has kept quiet about its commercialisation plans some analysts have suggested it will start making revenues from the drug in 2019 - the year in which Roche's U.S. patent on Herceptin expires.

"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.