Mvasi Approved as Biosimilar to Avastin
September 14, 2017 – The U.S. FDA has approved Mvasi™ (bevacizumab-awwb), manufactured by Allergan and Amgen, for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, and cervical cancer. Although considered a biosimilar to Genentech’s Avastin® (bevacizumab), Mvasi does not currently share Avastin’s indications for treatment of ovarian, fallopian tube, or primary peritoneal cancer, as they are currently protected by Orphan Drug Exclusivity.
Dosage of Mvasi varies based on the indication. The drug will be available as a 100mg/4mL or 400mg/16mL solution in single dose vials for IV infusion. It is not considered a generic to Avastin, and cannot be automatically interchanged.
Mvasi is the seventh biosimilar to be approved for use in the United States so far by the FDA. Launch for Mvasi will likely be delayed until July 2019, when an Avastin patent is set to expire.
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.