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.

Liz

Liz

Kære Gæster! Jeg hedder Liz og har kronisk polyartrit selv siden barndommen og taler fra erfaring. I øvrigt arbejder jeg inden for mit fagområde som grafisk designer inden for reumatologi. I min fritid elsker jeg fotografering. Jeg ønsker dig meget læselyst. Besøg min Spinal Muskelatrofi Blog ######## Kära Gäster! Mitt namn är Liz och jag har kronisk polyartrit sedan barndomen och talar från erfarenhet. Samtidigt jag jobbar också som grafisk designer formgivare inom reumatologi. På min fritid älskar jag fotografering. Besök min Spinal Muskelatrofi Blogg

En mening om “Sandoz receives positive CHMP opinion for proposed biosimilar infliximab

  • Liz
    april 11, 2018 kl. 12:05 am
    Permalink

    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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