Mylan N.V.and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan´s OgivriTM (trastuzumabdkst), a biosimilar to Herceptin® (trastuzumab), co-developed with Biocon. OgivriTM 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).
OgivriTM 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 Herceptin in various markets globally.
FDA approval was based on robust data from structural and functional characterization using multiple orthogonal techniques, nonclinical studies and pharmacokinetic evaluation in healthy subjects and patients and a safety, efficacy and immunogenicity study in relevant patient populations, which compared OgivriTM to Herceptin. The data demonstrated that OgivriTM is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. The FDA´s decision follows the unanimous vote by the FDA Oncologic Drugs Advisory Committee (ODAC) in July 2017 recommending approval of Mylan´s biosimilar to Herceptin.
