Sandoz receives positive CHMP opinion for proposed biosimilar infliximab

Holzkirchen, Germany, March 23, 2018Sandoz, a Novartis division and the global leader in biosimilars, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of infliximab, a proposed biosimilar to reference medicine infliximab** *.

The CHMP opinion recommends the proposed Sandoz biosimilar infliximab for the treatment of all indications of its reference medicine across gastroenterology, rheumatology and dermatology.

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  1. Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and dermatology

    Positive opinion is based on a comprehensive clinical and non-clinical data package that is expected to confirm that Sandoz biosimilar infliximab matches the reference medicine

    This recommendation marks the third CHMP positive opinion granted for a Sandoz biosimilar in 12 months, following Erelzi® and Rixathon®; Sandoz is on track to launch several biosimilars of major oncology and immunology biologics by 2020

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