Lupin and YL Biologics Receive Japanese Approval for Etanercept Biosimilar

Lupin and YL Biologics announced today that they have received approval to manufacture and sell YLB113, a biosimilar etanercept product, in Japan. The product will be Lupin’s first biosimilar to come to the Japanese market.

Cyrus Karkaria, PhD, president of Lupin, said in a statement that “the successful filing and eventual approval of YLB113 is a major step in the fight against [autoimmune] diseases, and will allow access to an effective, affordable equivalent. After significant investment in our biotechnology [research and development] division over the years, this is the first biosimilar for regulated markets developed in-house at Lupin and the first etanercept biosimilar developed by an Indian pharmaceutical player. It is an important achievement for us that sets the tone for future biosimilar development.”

Lupin submitted its application for the etanercept biosimilar to Japanese authorities in 2018 for all indications of the reference product. The application included data from a global phase 3 clinical trial of the drug, in comparison with the reference Enbrel, conducted at 110 centers in 11 countries.

The study’s primary endpoint was equivalent improvement in rheumatoid arthritis, measured by American College of Rheumatology (ACR) criteria for 20% improvement (ACR20), at week 24. YL Biologics reported in February 2018 that the proportion of patients achieving ACR20 fell within a prespecified 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.

In addition to Japan, Lupin is targeting other major regulatory territories with its biosimilar etanercept; the drug maker announced in May 2018 that it has submitted a marketing authorization application for the biosimilar to the European Medicines Agency. In 2018, Lupin said that it would submit the biosimilar for US regulatory approval in the third quarter of 2020.