PITTSBURGH and BENGALURU, India — Mylan N.V. has received Food and Drug Administration approval for Ogivri (trastuzumab-dkst), a biosimilar oncology drug co-developed with Biocon Ltd.

Mylan said Friday that Ogivri is a biosimilar of Herceptin (trastuzumab) from Genentech, indicated for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

Ogivri is the first FDA-approved Herceptin biosimilar and the first biosimilar from Mylan and Biocon’s joint portfolio approved in the United States, according to Mylan.

Heather Bresch

Mylan added that it expects to potentially be the first company to offer a Herceptin biosimilar, based on its ability to secure global licenses for its trastuzumab product from Genentech and its parent company Roche earlier this year. Mylan said the milestone secured a clear pathway to commercialize its biosimilar of Herceptin in various markets globally.

“The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.S. health care system,” Mylan chief executive officer Heather Bresch said in a statement. “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. As one of the nation’s leading suppliers of cancer medicines, Mylan is excited to add to our portfolio a product representing a new generation of targeted therapies that have radically changed the way the disease is treated.”

In the United States, an estimated 250,000 new cases of women’s breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed this year. About 20% to 25% of primary breast cancers are HER2-positive.

“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,” commented Bicon CEO Arun Chandavarkar. “I sincerely acknowledge the contribution of every member of our teams who made this happen. This is the first biosimilar trastuzumab to be approved by the U.S. FDA and opens the door to a high-quality, more affordable option for the treatment of eligible cancer patients in the U.S.”

Herceptin had U.S. sales of more than $2 billion for the 12 months ended Sept. 30, according to IQVIA data reported by Mylan.

Mylan added that the Herceptin biosimilar also is under review by regulatory authorities in Australia, Canada, Europe and several additional markets. The medication is already approved in 19 countries, including India, where Biocon is based, providing wider access to this more affordable biologic for cancer patients.