Sandoz acquires Pfizer’s biosimilar infliximab in EEA

February 15, 2016 11:07 AM

Sandoz, a Novartis company, announced that it has acquired from Pfizer the rights for the development and commercialization of biosimilar infliximab in the 28 countries that form the European Economic Area (EEA).

Infliximab is a tumor necrosis factor alpha (TNF-alfa) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis (RA) and psoriasis.

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

Under the terms of the deal, Sandoz plans to complete the clinical study program and submit the biosimilar infliximab to the European Medicines Agency (EMA) for regulatory approval. Included in the program is a global phase III trial – REFLECTIONS (B537-02) investigating the safety and efficacy of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate. Sandoz acquired the rights to infliximab, following Pfizer’s commitments to the European Commission in connection with the acquisition of Hospira, Inc. to divest the program.

Sandoz has a biosimilar pipeline with programs in various stages of development and regulatory filing including biosimilars adalimumab and etanercept that are also anti TNF-alfa medicines. The company already announced five regulatory filings, which include biosimilar etanercept filed with both the EMA and the US FDA.

* Pfizer retains commercialization and manufacturing rights to infliximab in all countries outside of the EEA.

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