Blog Big Molecule Watch June 09, 2020

Biosimilars Approvals: Nepexto Receives European Marketing Authorization, Ziextenzo and Riximyo Receive Health Canada Approval

Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product.  The marketing authorization follows a positive opinion from the Committee for Medicinal Products for Human Use earlier this year based on preclinical and clinical studies demonstrating bioequivalence to the reference product, Enbrel.

Today, Sandoz Canada announced that Health Canada has approved the launch of Ziextenzo (pegfilgrastim), and Riximyo (rituximab) in Canada.  According to the announcement, Sandoz Canada received a Notice of Compliance from Health Canada on April 21, 2020 for the use of Ziextenzo to reduce the incidence of febrile neutropenia, a decrease in while blood cells resulting from chemotherapy.  Likewise, Riximyo was approved on April 28, 2020 for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis.

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