Mylan N.V. and Biocon Ltd announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Ogivri (trastuzumab-dkst), abiosimilar to Herceptin(trastuzumab), 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-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S. Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan’s 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 Herceptinin various markets globally.
Mylan is a global leader in the development and manufacturing of complex products, including biosimilar medicines, with a portfolio of 16 biosimilar and insulin analog products – one of the industry’s largest and most diverse portfolios.
Mylan CEO Heather Bresch commented: “The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.S. healthcare system. It will allow us to bring this important biosimilar – the first of its kind – to market in the U.S., expanding cancer-patient access to more affordable treatment.”
Mylan President Rajiv Malik added: “ 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.
“This latest approval,amongour 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.”
Kiran Mazumdar-Shaw, CMD Biocon,said: “The U.S. FDA’s 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.”
Dr. Arun Chandavarkar, CEO & Joint MD, Biocon, added: “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.”.