Sandoz, a company owned by Novartis, announced last week that it has procured the rights to develop and commercialize PF_06438179 (infliximab) from Pfizer.
These rights will cover the 28 countries that make up the European Economic Area (EEA). Sandoz is a worldwide leader in biosimilars. Infliximab is a biosimilar that inhibits the tumor necrosis factor alpha (TNF-alpha). It is used to treat a variety of autoimmune diseases, which includes rheumatoid arthritis (RA) and psoriasis.
For patients with autoimmune diseases such as RA, Sandoz sees infliximab as a vital treatment option. The company plans to complete the development and registration of the biosimilar so it will be made readily accessible to patients who suffer from these autoimmune diseases all across Europe.
The terms of the purchase state that Sandoz will finish a clinical study program before submitting infliximab to the European Medicines Agency (EMA) for approval and registration with the European Commission. The clinical study program will include the global phase III trial, REFLECTIONS (B537-02), which will explore the combining of infliximab with methotrexate to see if it is safe and effective in patients with RA who have had negative responses to methotrexate.