Date: 2016-02-12
Type of information: Product acquisition
Compound: PF-06438179 (biosimilar version of Remicade® (infliximab))
Company: Sandoz (Switzerland) Pfizer (USA - NY)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Dermatological diseases
Type agreement: product acquisition
Action mechanism: monoclonal antibody/biosimilar. Infliximab is a tumor necrosis factor alpha (TNF-alpha) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis (RA) and psoriasis.
Disease: rheumatoid arthritis, psoriasis
Details:
- • On February 12, 2016, Sandoz announced that it has acquired from Pfizer the rights for the development and commercialization of PF-06438179 (biosimilar infliximab) in the 28 countries that form the European Economic Area (EEA). Pfizer retains commercialization and manufacturing rights to infliximab in all countries outside of the EEA. 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 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.
- Sandoz acquired the rights to infliximab, following Pfizer’s commitments to the European Commission in connection with the acquisition of Hospira to divest the program. Sandoz has a leading biosimilar pipeline with programs in various stages of development and regulatory filing including biosimilars adalimumab and etanercept that, like infliximab, are anti-tumor necrosis factor alpha (TNF-alpha) medicines. The company plans to make 10 regulatory filings over a three year period (2015-2017) having already announced five, which include biosimilar etanercept filed with both the EMA and the FDA.
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