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


Shares of Biocon rallied 15% after the drug regulator, USFDA approves Mylan and Biocon's co-developed product, Ogivri, the first biosimilar for Trastuzumab for treatment of HER2-Positive breast and gastric cancers.

"The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs".

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Gottlieb added that the FDA is "committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs".

Mylan and Biocon announced that the European Medicines Agency (EMA) has accepted a resubmitted application for their Herceptin biosimilar, as well as one for their copy of Amgen's chemo drug, Neulasta. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

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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).

Mylan said in a statement Ogivri is the first biosimilar in its collaboration with Biocon to get U.S. 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 United States patent on Herceptin expires. This was first ever biosimilar made by an India drug maker to get a US FDA nod.

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Shares of Biocon settled with gains of 15 per cent on the bourses, after the company said it has received regulatory approval to market a biosimilar of cancer drug Herceptin in the USA, following which the market capitalisation of the company improved by Rs 4,020 crore.