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ibusinesslines.com July 23, 2018


FDA Approves Ogivri, Biosimilar to Herceptin, to Treat HER2

05 December 2017, 02:18 | Melissa Porter

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

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

Mylan N.V. (MYL) and Biocon Ltd. said that the U.S. Food and Drug Administration has approved Mylan's Ogivri or trastuzumab-dkst, a biosimilar to Herceptin or trastuzumab, co-developed with Biocon.

"It will allow us to bring this important biosimilar - the first of its kind - to market in the USA, expanding cancer-patient access to more affordable treatment".

The agency's commissioner, Scott Gottlieb, said that biosimilar approvals help "to promote competition that can lower health care costs".

The biosimilar's approval was based on a review of evidence including extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data. "We're committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs".


Shares of Biocon hit a one-year high in Monday's trade as the markets cheered after the USFDA validated its biosimilar cancer drug Trastuzumab and approved it for the USA market on Friday night.

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.

Mylan and Biocon's biosimilar for Herceptin also is under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It will allow us to bring this important biosimilar, expanding cancer-patient access to more affordable treatment.

"We are extremely pleased with the acceptance of our [marketing authorization application in Europe]", Rajiv Malik, Mylan's president, said in a press release. Ogivri is one of many biosimilars in our robust pipeline that we look forward to introducing in the coming years as part of our ongoing commitment to increasing access to important medicines for patients.



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