February 12, 2016
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Sandoz attains European rights to biosimilar to infliximab from Pfizer

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Sandoz, a Novartis company, announced it has acquired the rights to Pfizer’s biosimilar to infliximab to develop and commercialize across the 28 countries comprising the European Economic Area, according to a company press release.

“Infliximab is one of the most important biologic therapy options for people living with severe autoimmune diseases such as rheumatoid arthritis,” Richard Francis, division head and CEO of Sandoz, said in the release. “We intend to complete the development and registration of PF-06438179 and make it available to patients across Europe as part of our robust portfolio of immunology treatments.”

Sandoz will complete the clinical studies of the infliximab (Remicade, Janssen) biosimilar and submit the paperwork to the European Medicines Agency for regulatory review and approval. The deal follows Pfizer’s agreement with the European Commission to divest the biosimilar. Currently, Sandoz owns the rights to two additional tumor necrosis factor alpha inhibitor biosimilars, adalimumab (Humira, AbbVie) and etanercept (Enbrel, Amgen).

In the Europe and the United States, infliximab is approved to treat rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease and ulcerative colitis. The biosimilar to infliximab is currently involved in the REFLECTIONS clinical trial of patients with RA in combination with methotrexate.

Reference: http://www.sandoz.com/