Mylan’s Ogivri Approved as Biosimilar to Herceptin
- By BSTQ Staff
Mylan’s Ogivri (trastuzumab-dkst) has been approved by the U.S. Food and Drug Administration as a biosimilar to Genentech’s Herceptin (trastuzumab) for the treatment of patients with HER2-overexpressing breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Approval was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, and clinical studies, including clinical immunogenicity between Ogivri and Herceptin, which demonstrated Ogivri is highly similar to Herceptin and there are no clinically meaningful differences between the products.
References
- FDA Approves Ogivri as a Biosimilar to Herceptin. U.S. Food and Drug Administration press release, Dec. 1, 2017. Accessed at www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm587404.htm.
