Sandoz strengthens its biosimilars portfolio with acquisition of Pfizer's biosimilar infliximab in EEA

Deal strengthens Novartis immunology portfolio which includes investigational biosimilars adalimumab, etanercept and rituximab.

"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 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 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 is committed to increasing patient access to high-quality biosimilars. It is the pioneer and global market leader in biosimilars and was the first to launch biosimilars in the United States, Europe and Japan. 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 3-year period (2015–2017) having already announced five, which include biosimilar etanercept filed with both the EMA and the FDA. As part of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its deep experience and capabilities in development, manufacturing and commercialization.