Biocon and Mylan have received the US FDA approval Ogivri. This Mylan’s biosimilar to Herceptin or trastuzumab was co-developed with Biocon. Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-over-expressing breast cancer and metastatic stomach cancer.
Ogivri is the first FDA-approved biosimilar to Herceptin. It is also the first biosimilar from Mylan and Biocon’s joint portfolio approved in the US. Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of its ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year. This milestone secured a clear pathway to commercialize Mylan’s biosimilar to Herceptin in various markets globally, stated the company release.
According to, CEO, Mylan said the approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the US healthcare system. It will allow us to bring this important biosimilar, expanding cancer-patient access to more affordable treatment. 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.
“We are proud to receive FDA approval of Ogivri. Bringing such complex products to the market not only requires sound and robust science and a talented research and development team, but also the ability to manage legal and regulatory complexities and invest significantly in manufacturing capabilities, said Rajiv Malik, president, Mylan.
“This latest approval, among our other many accomplishments around the globe, not only continues to highlight Mylan’s ability to differentiate itself from its peers, but also underscores why we have become a preferred partner of choice,” he added.
The US FDA approval for our biosimilar trastuzumab is indeed a crowning moment that puts us in an exclusive league of global biosimilar players. It strengthens our resolve to focus on developing affordable biologics that can make cancer care both more effective and more equitable around the world. It is an important milestone in our journey of developing advanced therapies that have the potential to benefit billions of patients, said Kiran Mazumdar-Shaw, CMD Biocon.
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.
Mylan and Biocon's biosimilar for Herceptin also is under review in Australia, Canada, Europe and several additional markets. It is approved in 19 countries, including India.
Biocon, mylan, us fda nod, ogivri, biosimilar, trastuzumab, her2-positive breast, gastric cancers
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