Ogivri Approved as First Biosimilar to Herceptin
December 1, 2017 – The U.S. FDA has approved Ogivri™ (trastuzumab-dkst), manufactured by Mylan in conjunction with Biocon, as the first biosimilar to Roche’s Herceptin® (trastuzumab). Ogivri is indicated to treat patients who have HER2-overexpressing breast or metastatic stomach cancer (either gastric or gastroesophageal junction adenocarcinoma).
Recommended dosing with Ogivri is based on indication; the drug is administered via intravenous (IV) infusion. A monoclonal antibody, Ogivri works by attaching to HER2 receptors of cancer cells and inhibiting cell growth. Like Herceptin, it carries a black box warning cautioning that its use may be associated with cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.
Biosimilars must demonstrate comparable safety and efficacy to their reference product to receive FDA approval. However, unlike generics, they are not automatically interchangeable with their reference product. Ogivri is only the second biosimilar for the treatment of cancer to be approved for use in the United States.
Due to a licensing agreement between Mylan and Roche, Ogivri is not expected to launch until 2019.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.