Mylan, Biocon launch Herceptin biosimilar Ogivri

Mylan and Biocon are introducing Ogivri (trastuzumab-dkst), a biosimilar to Genentech’s Herceptin (trastuzumab). Ogivri is available in 420 mg multidose vials and 150 mg single-dose vials.

Ogivri was the first biosimilar trastuzumab approved by the Food and Drug Administration and unanimously recommended by the FDA Oncologic Drugs Advisory Committee.

Ogivri is approved for all indications of Herceptin including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

“As one of the largest suppliers of oncology medicines in the United States, we are proud to offer Ogivri, biosimilar trastuzumab, in both the 420mg and 150mg strengths and help increase more affordable access to this important treatment option for breast and gastric cancer patients," Mylan President Rajiv Malik said. "With regulatory approval for our biosimilar trastuzumab in more than 80 countries worldwide, we are bringing vast global biosimilars experience to the United States and look forward to continuing our work with all stakeholders in the healthcare system to reduce costs, improve access and advance care. With Ogivri, Fulphila and our generic oncology portfolio, Mylan is uniquely positioned to provide a broad range of treatment options for oncology patients,”