Lupin's joint venture (JV) YL Biologics (YLB) has successfully completed global Phase III clinical trial of its investigational Etanercept biosimilar (YLB113). The Phase III study of YLB113 was a multinational randomized double-blind controlled trial of 52 weeks duration which included more than 500 patients with rheumatoid arthritis (RA) in 11 countries. It compared YLB113's efficacy and safety directly against Enbrel (of Amgen/Pfizer) which has a global market of $11 billion (IQVIA MAT Q3 2017), and is a widely successful biologic agent globally used for the treatment of multiple autoimmune disorders including RA. YLB is a joint venture between the company and Yoshindo in Japan.
The primary endpoint was an equivalent improvement in the rheumatoid arthritis, as measured by American College of Rheumatology 20 (ACR20) response rate. The ACR20 response rate of YLB113 has been found to be within a pre-defined equivalence margin that is expected by most advanced regulatory agencies for marketing authorization. In addition, safety and immunogenicity (antibody formation) of YLB113 was also found to be similar to Enbrel indicating therapeutic equivalence.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.