Japan-based Yoshindo and Lupin joint venture (JV) YL Biologics (YLB) has reported positive results from a Phase lll clinical trial evaluating the efficacy and safety of YLB113 in comparison with Enbrel to treat patients with rheumatoid arthritis (RA).
The multinational, randomised, double-blind controlled trial was conducted over a period of 52 weeks and enrolled more than 500 RA patients in 11 countries.
A total of 110 rheumatology clinics were chosen to conduct the trial throughout Japan, India, and Europe.
The trial successfully met its primary endpoint, which included an equivalent improvement in RA, as measured by American College of Rheumatology 20 (ACR20) response rate.
The ACR20 response rate of YLB113 was found to be within a pre-defined equivalence margin, which is in line with most of the regulatory agencies for marketing authorisation.
Furthermore, safety and immunogenicity of YLB113 was also found to be similar to Enbrel indicating therapeutic equivalence.
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Lupin MD Nilesh Gupta said: “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.”
YLB is currently preparing a regulatory dossier for submission to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for obtaining marketing authorisation for YLB113, which is an etanercept biosimilar currently under development by YLB.
Enbrel has been developed by Amgen/Pfizer and is a successful biologic agent globally used for treatment of multiple autoimmune disorders, including RA.