Lupin pharmaceuticals has entered into an agreement with Nichi-Iko for the distribution, promotion, and sale of its proposed biosimilar etanercept, YLB113, in Japan.
Lupin pharmaceuticals announced this week that it has entered into an agreement with Nichi-Iko for the distribution, promotion, and sale of its proposed biosimilar etanercept, YLB113, in Japan.
The proposed biosimilar, which is awaiting Japanese regulatory approval, was developed by YL Biologics in a joint venture between a subsidiary of Lupin, Lupin Atlantis Holdings SA, and Yoshindo. In March, YLB113 was submitted for regulatory approval to the Pharmaceuticals and Medicals Device Agency (PMDA) in Japan following conclusion of a phase 3 study.
The study was a 52-week, multinational, randomized, double-blind, controlled trial that included more than 500 patient with rheumatoid arthritis (RA) in 11 countries. The trial sought to determine the efficacy and safety of YLB113 compared directly with the reference etanercept product, Enbrel.
Researchers found that the safety and immunogenicity of YLB113 were similar to those of the reference product. In addition, the study achieved its primary endpoint of equivalent improvement in RA, as measured by the American College of Rheumatology’s criteria for 20% improvement, or ACR20.
“The successful commercialization of our first biosimilar will help our foray into the fast-growing biologics space and also provide patients in Japan access to a high quality, affordable alternative,” said Nilesh Gupta, managing director of Lupin Limited in a statement.
If it receives regulatory approval, the product will be launched in Japan by Nichi-Iko.
In addition to filing the potential biosimilar for approval in Japan, Lupin has also submitted a marketing authorization application for YLB113 to the European Medicine’s Agency for the treatment of RA, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis.