Biosimilar Regulatory Approval Updates

Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD).  Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab.  According to the press release, RANIVISIO (ranibizumab) will be the first ophthalmology biosimilar of LUCENTIS to be commercialized in Europe.

On August 19, 2022, Celltrion Healthcare announced that the European Commission has approved VEGZELMA, a biosimilar bevacizumab, for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer.  According to Celltrion, the efficacy and safety profile of VEGZELMA was similar to the EU-approved reference product AVASTIN®. The approval follows the recommendation for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2022.  In September 2021, Celltrion also filed for approval of VEGZELMA with FDA, and according to Celltrion, approval is expected during the third quarter of 2022.

On July 21, 2022, Sandoz announced that the FDA has accepted for review its Supplemental Biologics License Application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar HYRIMOZ® (adalimumab-adaz).  According to Sandoz, the application includes the indications of the reference product HUMIRA® (adalimumab) not protected by orphan exclusivity.  As we previously reported, the European Medicines Agency (EMA) also recently accepted, on June 24, 2022, Sandoz’s application for its proposed high-concentration HYRIMOZ®.