Top-line results for PF-06438179 (biosimilar infliximab) demonstrate equivalent efficacy to reference product
Sep 16, 2016
Sandoz, a Novartis division, the pioneer and global leader in biosimilars acquired the rights from Pfizer for the development, commercialization and manufacture of PF-06438179 in the 28 countries that form the European Economic Area (EEA)* in February 2016 where it is known as GP1111.
The confirmatory study (REFLECTIONS B537-02), evaluating the efficacy, safety and immunogenicity of PF-06438179 (biosimilar infliximab) to reference product Remicade® (infliximab), met its primary endpoint.
Results demonstrate equivalent efficacy as measured by the American College of Rheumatology 20 (ACR20) response at Week 14.
Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the worldwide Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached more than 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.