Blog Big Molecule Watch February 16, 2022

International Biosimilar Approval and Launch Updates

Earlier this month, Samsung Bioepis Co. Ltd. announced that Health Canada approved ONTRUZANT (also known as SB3), a biosimilar referencing Herceptin (Trastuzumab), for the treatment of adults with Early Breast Cancer, Metastatic Breast Cancer and metastatic gastric cancer. ONTRUZANT is Samsung Bioepis’ fifth biosimilar approved for the use in Canada following BRENZYS (etanercept) in August 2016, RENFLEXIS (infliximab) in December 2017, HADLIMA (adalimumab) in May 2018, AYBINTIO (bevacizumab) in November 2021.

Last week, Selexis SA and Generium JSC announced that GENOLAR, Generium’s biosimilar of omalizumab, is now commercially available in Russia for the treatment of persistent atopic bronchial asthma and resistant chronic idiopathic urticaria. According to the press release, GENOLAR is the third Selexis biosimilar to reach the market under commercial license agreements between Generium and Selexis.

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