Blog Big Molecule Watch August 21, 2020

Global Biosimilars Approval and Launch Updates

Shanghai Henlius Biotech, Inc. announced on August 14, 2020 the approval of its trastuzumab biosimilar HLX02 by the National Medical Products Administration (NMPA).  This same product was approved by the European Commission on July 27th.  According to the press release, this is the the first China-developed mAb biosimilar to be approved both in China and in the EU.  Trastuzamab is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.

Sandoz Canada Inc. announced on August 19, 2020 that it reached a negotiated agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) and launched ZIEXTENZO  (pegfilgrastim) and RIXIMYO (rituximab) in Canadian hospitals and pharmacies. This follows the recent approval of the two biosimilars by Health Canada.  ZIEXTENZO is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic agents. RIXIMYO is approved for the treatment of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL), as well as the autoimmune disease rheumatoid arthritis (RA).

Samsung Bioepis Co., Ltd. announced yesterday that the European Commission (EC) granted marketing authorization for AYBINTIO (bevacizumab) for the treatment of metastatic carcinoma of the colon or rectum (mCRC), metastatic breast cancer (mBC), non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer (mRCC), epithelial ovarian, fallopian tube and primary peritoneal cancer and cervical cancer.  AYBINTIO is Samsung Bioepis’s fifth biosimilar approved for use in Europe.

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