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Sandoz reveals plans to complete a Phase III development program for Pfizer’s infliximab and file for registration in the EU.
On Feb. 12, 2016 Sandoz announced that the company had acquired the rights for development and commercialization of Pfizer’s biosimilar infliximab (PF-06438179) in the European Economic Area (EEA). Infliximab is a tumor necrosis factor alpha (TNF-α) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis (RA) and psoriasis. Sandoz acquired the rights to the biosimilar following Pfizer’s commitment to the European Commission to divest the program as part of a condition of Pfizer’s acquisition of Hospira, Inc.
In August 2015, the European Commission (EC) said that it would approve a merger between Pfizer and Hospira on the condition that Pfizer divest its biosimilar infliximab and selected sterile injectables. The EC said that the company could have “overlapping interests” in biosimilars to infliximab unless the divestiture occurred. Hospira’s Inflectra, an infliximab biosimilar, is already on the market in Europe. The commission said if Pfizer decided not to continue development of its own infliximab biosimilar following the Hospira acquisition, there would be fewer competitors for the product in the market.
Under the terms of the deal, Sandoz plans to complete the clinical study program and submit the biosimilar to the European Medicines Agency (EMA) for regulatory approval and registration with the European Commission. 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 alone.