Mylan has become the first pharma company to win U.S. approval for a biosimilar of Roche's big-selling cancer antibody Herceptin.
Amgen/Allergan, Pfizer, and Samsung Bioepsis are also developing biosimilar Herceptin products for the USA and worldwide markets, but analysts have suggested that Roche's brand will not see a dramatic reduction in sales after the rivals launch, in part because use of the drug in combination with newer HER2 drug Perjeta (pertuzumab) is on the rise.
The US Food and Drug Administration (FDA) on Friday approved Mylan N.V. and Biocon Ltd's biosimilar for Roche's drug Herceptin, used in the treatment of breast and metastatic stomach cancer.
Ogivri is already approved in 19 countries around the world, and Mylan and Biocon are now working with regulatory authorities in Australia, Canada, and Europe for approval for the Herceptin biosimilar. Ogivri has been approved as a biosimilar, not as an interchangeable product, the regulator said. "We now look forward to moving ahead with the rest of the regulatory review process in Europe and to bringing these important treatment options to cancer patients". "We are proud to receive FDA approval of Ogivri".
"We are extremely pleased with the acceptance of our [marketing authorization application in Europe]", Rajiv Malik, Mylan's president, said in a press release. It strengthens our resolve to focus on developing affordable biologics that can make cancer care both more effective and more equitable around the world.
"Biocon and Mylan have a shared commitment to enhance access to cutting-edge bio-therapeutics and this approval will enable us to provide an affordable alternative for cancer care that will address the unmet needs of patients in the USA", Biocon CMD Kiran Mazumdar-Shaw said. Dr Arun Chandavarkar, CEO & Joint MD, Biocon, added that the 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. It is approved in 19 countries, including India.
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