WASHINGTON — The FDA granted a first-ever approval on Friday for a biosimilar for the HER2 receptor inhibitor trastuzumab (Herceptin).
To be sold as Ogivri and carrying the generic name trastuzumab-dkst, the biosimilar received approval for treatment of HER2-positive breast cancer and metastatic HER2-positive stomach cancer (gastric or gastroesophageal junction adenocarinoma). The approval followed unanimous endorsement in July by an FDA advisory committee.
“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower healthcare costs,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “This is especially important when it comes to diseases like cancer, that have a high cost burden for patients. We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”
Evidence supporting the approval application included “extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data, and other clinical safety and effectiveness data that demonstrates Ogivri is biosimilar to Hercepin,” according to the FDA statement. The agency emphasized that Ogivri received approval as a biosimilar, not as a product that is interchangeable with branded trastuzumab.
Supporting evidence included data from a single clinical trial comparing the biosimilar to branded trastuzumab approved for use in Europe (EU-trastuzumab). The FDA advisory committee agreed with the assessment that comparative analytic and pharmacokinetic data showed no substantive differences between the biosimilar, EU-trastuzumab, and the branded trastuzumab approved for marketing in the United States.
As is true of branded trastuzumab in the U.S., labeling for the biosimilar will include a boxed warning about increased risks of cardiomyopathy, infusion reaction, pulmonary toxicity, and embryo-fetal toxicity associated with use of the biosimilar product.
Mylan GmbH will market Ogivri. Herceptin, manufactured by Genentech, had been the only approved formulation of trastuzumab in the U.S. since 1998.