Lupin, YL Biologics gets PMDA approval for Etanercept biosimilar in Japan

"YL Biologics Ltd, a joint venture between Lupin's subsidiary Lupin Atlantis Holdings SA (LAHSA) and Yoshindo Inc in Japan, and Lupin (through its Japanese subsidiary, Kyowa Pharmaceutical Industry Co Ltd) have received an approval to manufacture and sell their biosimilar Etanercept in Japan," Lupin said in a regulatory filing.

New Delhi: Drug major Lupin Ltd recently said its Japanese subsidiary and YL Biologics have received an approval to manufacture and sell their biosimilar Etanercept in Japan. Pharmaceutical and Medical Devices Agency (PMDA) in Japan approved the product following an NDA submission by Lupin and YLB after the results of this Phase III study.

Biosimilar Etanercept is indicated to treat moderate to severe rheumatoid arthritis (RA) and juvenile idiopathic arthritis.

"YL Biologics Ltd, a joint venture between Lupin's subsidiary Lupin Atlantis Holdings SA (LAHSA) and Yoshindo Inc in Japan, and Lupin (through its Japanese subsidiary, Kyowa Pharmaceutical Industry Co Ltd) have received an approval to manufacture and sell their biosimilar Etanercept in Japan," Lupin said in a regulatory filing.

In February 2018, YL Biologics had announced the completion of the global phase III study of their biosimilar Etanercept.

Also Read: Lupin gets USFDA nod to Sildenafil tablets to treat erectile dysfunction

Based on the results of this Phase III study, YL Biologics (YLB) and Lupin (through Kyowa Pharmaceutical Industry) submitted a New Drug Application (NDA) to the Pharmaceutical and Medical Devices Agency (PMDA) in Japan in March 2018.

"We now look forward to bringing this important product to Japanese patients. We have a carefully selected, high-value pipeline of biosimilars going forward and are committed to advancing research and development in this space," Lupin Managing Director Nilesh Gupta said.

This is part of our overall move to evolve our complex generic portfolio and offer better access to affordable and high-quality products for patients across the world, he added.