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Lupin-Yoshindo joint venture company YL Biologics succeeds rheumatoid arthritis drug trials


YL Biologics, a joint venture between Lupin and Yoshindo, has announced that its phase-III clinical studies on a biosimilar version of Etanercept (YLB113) has met with a successful outcome.

By Team ABLE

YL Biologics, a joint venture between Lupin and Yoshindo, has announced that its phase-III clinical studies on a biosimilar version of Etanercept (YLB113) has met with a successful outcome.

Lupin has said in a statement that the 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, 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 which included over 260 Japanese patients from 62 rheumatology clinics, a scale that is distinct for a global RA trial in Japan.

“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,” said Nilesh Gupta, MD of Lupin Limited.