Lupin: Japanese regulator gives approval for Etanercept

Lupin Limited's, through its Japanese subsidiary Kyowa Pharmaceutical, has received an approval to manufacture and sell their biosimilar Etanercept in Japan, said a company release on Friday. The drug is used to treat Rheumatoid Arthritis and Juvenile Idiopathic Arthritis.

YL Biologics Limited and Lupin's Japanese subsidiary Kyowa Pharmaceutical Industry have received the approval for biosimilar Etanercept in the Japanese market. YL Biologics is also a joint venture between Lupin’s subsidiary Lupin Atlantis Holdings SA (LAHSA) and Japan-based Yoshindo Inc. 

The approval pertains to treating moderate to severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis following successful completion of a Phase III study of Etanercept (YLB113) by YL Biologics. The study was a randomized double-blind controlled trial with 500 patients across 11 countries that lasted for 52 weeks comparing YLB113’s efficacy against Enbrel. Based on its results YLB and Lupin's subsidiary, Kyowa Pharmaceutical submitted an NDA to the Japanese drug regulator Pharmaceutical and Medical Devices Agency (PMDA) in March 2018.

The biosimilar is part of Lupin's move to evolve a complex generic portfolio.

On Tuesday, at 14:23 hours, the stock of Lupin was quoting Rs. 735.00 per share, up by 0.81 per cent on BSE, while the benchmark index BSE Sensex was pretty positive up by 189 points or 0.50 per cent at 37,998.81.