International Biosimilar Approval and Launch Updates

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On November 25, 2021, Japan-based Mochida Pharmaceutical Co. announced that its adalimumab biosimilar, Adalimumab BS MA, had been launched in Japan following the listing of the drug on the National Health Insurance. According to the press release, Adalimumab BS MA is the first adalimumab biosimilar to Humira currently distributed in Japan.

On December 1, 2021, TOT BIOPHARM announced that its self-developed Pusintin® (TAB008, bevacizumab injection) was approved by the National Medical Products Administration for marketing in mainland China (i.e., excluding Hong Kong, Macau and Taiwan regions) for the treatment of patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer and patients with metastatic colorectal cancer.

On December 3, 2021 Shanghai Henlius Biotech, Inc. announced that it had received approval for its bevacizumab biosimilar (Hanbeitai), from the National Medical Products Administration. According to the press release, Hanbeitai is indicated for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer. Hanbeitai is Henlius Biotech’s fourth monoclonal antibody biosimilar approved in China, following approval of its rituximab, trastuzumab, and adalimumab biosimilars.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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