Big Molecule Watch
June 5, 2024

European Biosimilar Regulatory Update

In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab.

On May 22, Sandoz announced that it received marketing authorization from the European Commission for its WYOST® and JUBBONTI® denosumab biosimilars.  According to Sandoz, these two drug products are the first and only biosimilar versions of Amgen’s XGEVA® and PROLIA® in Europe.  WYOST® is approved for the treatment of cancer-related bone disease while JUBBONTI® is approved to treat osteoporosis.  Sandoz’s denosumab biosimilar products were approved by the FDA in March 2024.

On May 24, Celltrion announced that it received marketing authorization for OMLYCLO®, an omalizumab biosimilar product referencing Genentech’s XOLAIR®.  OMLYCLO® is approved for the treatment of allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps.  According to Celltrion, OMLYCLO® is the first omalizumab biosimilar for the treatment of allergic diseases to be approved by the European Commission.  In the United States, Celltrion submitted its BLA to the FDA for its omalizumab biosimilar in March 2024.

On May 28, Outlook Therapeutics announced that it received marketing authorization for LYTENAVA (bevacizumab gamma).  According to Outlook Therapeutics, LYTENAVA is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the European Union.  Outlook Therapeutics anticipates launching LYTENAVA in the first calendar quarter of 2025 and is currently evaluating an ongoing non-inferiority study to determine whether the data would be sufficient for Outlook Therapeutics to resubmit a BLA to the U.S. FDA.

On June 3, Bio-Thera Solution announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for AVZIZI® (bevacizumab), a biosimilar referencing Genentech’s AVASTIN®.  The CHMP’s positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization for the product.  AVZIZI® was approved by the FDA in December 2023.

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