YL Biologics Announces Positive Phase 3 Results for Proposed Etanercept Biosimilar

YL Biologics, a partnership forged between Lupin Pharmaceuticals and Yoshindo Inc to develop and market biosimilar therapies, has announced the successful completion of a global, phase 3 clinical trial of its proposed etanercept biosimilar, YLB113.

The multi-national, randomized, double-blind, 52-week, controlled trial of YLB113 was conducted in more than 500 patients with rheumatoid arthritis (RA) at 110 centers in 11 countries. The trial compared the safety and efficacy of the proposed biosimilar with that of the reference etanercept, Enbrel.

The study’s primary endpoint was equivalent improvement in RA, measured by American College of Rheumatology (ACR) criteria for 20% improvement (ACR20), at week 24. YL Biologics reports that the proportion of patients achieving ACR20 fell within a pre-defined equivalence margin used by most advanced regulatory agencies in granting marketing authorizations. The safety and immunogenicity of YLB113 were also similar to those of the reference Enbrel.

Secondary endpoints for the trial included ACR50 and ACR70 (50% and 70% improvement, respectively) at weeks 4, 8, 12, and 24, as well as improvement in disease activity score using 28 tender and swollen joint counts.

Lupin representative Nilesh Gupta, MD, said in a statement, “We are excited by the positive results from the phase 3 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 [research and development] capabilities so that more patients across the world can access affordable, high-quality biosimilars.”

Earlier this year, Lupin announced that it plans to file regulatory applications for the biosimilar etanercept in the first quarter of 2019 in Europe and in the third quarter of the 2020 fiscal year in the United States.

The company is also developing 6 additional biosimilars, including ranibizumab (referencing Lucentis), which is in phase 1 clinical development. Its remaining biosimilar candidates—pegfilgrastim (Neulasta), filgrastim (Neupogen), denosumab (Xgeva, Prolia), pertuzumab (Perjeta), and afliberept (Eylea)—are all in early stages of development.