YLB’s phase III clinical trial of Etanercept biosimilar meets positive outcome

The study was a multinational randomised double-blind controlled trial of 52 weeks duration which included more than 500 patients with rheumatoid arthritis in 11 countries

YL Biologics (YLB) has announced that a global phase III clinical trial of its investigational Etanercept biosimilar (YLB113) has met with successful outcome. YLB is the joint venture of Lupin and Yoshindo in Japan. The phase III study of YLB113 was a multinational randomised 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 US $11 billion (IQVIA MAT Q3 2017), and is a widely successful biologic agent globally used for the treatment of multiple autoimmune disorders including RA. The study was conducted at 110 rheumatology clinics across Japan, Europe and India. This study included over 260 Japanese patients from 62 rheumatology clinics, a scale that is distinct for a global RA trial in Japan.

The primary endpoint was an equivalent improvement in the RA, 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 authorisation. In addition, safety and immunogenicity (antibody formation) of YLB113 was also found to be similar to Enbrel indicating therapeutic equivalence.

“We are excited by the positive results from the phase III trial. This helps us put together a robust regulatory dossier intended for global regulatory filings for YLB113. We currently have multiple high value biosimilar candidates in our late-stage global development pipeline. We remain committed to advancing our biotech R&D capabilities so that more patients across the world can access affordable, high-quality biosimilars” said Nilesh Gupta, MD Lupin Limited. Dr Toshihiko Hibino, President of YLB expressed his satisfaction in achieving this important milestone that will recognise YLBs efforts in commercialising its first biosimilar for a crippling disease like Rheumatoid Arthritis in Japan. “We believe that it is our joint responsibility with our parent companies to subsidise the cost of RA treatment by offering a clinically equivalent biosimilar Etanercept to the Japanese patients”, he said. YLB is in the process of compiling a regulatory dossier for submission to PMDA for its marketing authorisation.