Biocon and Mylan nab FDA approval for Herceptin biosim

Dec 03, 2019

Biocon and Mylan have now launched Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab) in the United States following approval from the U.S Food and Drug Administration. Ogivri is available in a 420mg multi-dose vial and a 150mg single-dose vial in order to provide patient dosing and treatment flexibility.

Ogivri was the first biosimilar trastuzumab approved by the FDA 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.

Two supplemental Biologics License Applications were recently approved by the FDA, expanding themanufacturing capability for Ogivri, as well as Mylan and Biocon’s first U.S. biosimilar, Fulphila, a biosimilar to Neulasta.

"The U.S. launch of Ogivri, the biosimilar trastuzumab co-developed by Biocon Biologics and Mylan, marks a significant milestone in our biosimilars journey," said Christiane Hamacher, CEO, Biocon Biologics. "It is an important endorsement of our science, development and manufacturing capabilities in the area of monoclonal antibodies. The introduction of both 420mg multi-use vials and 150mg single-use vials of a high quality biosimilar trastuzumab with robust long-term efficacy and safety data will offer greater choice and value to patients, prescribers and payors in the U.S."

FDA approval of Ogivri was based on data demonstrating that Ogivri is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency.

Ogivri is the second biosimilar to be offered by Mylan through the Mylan-Biocon Biologics partnership in the U.S. and the second FDA-approved biosimilar through this collaboration to support cancer patients.

Read the full Biocon release