Lupin and YL Biologics’ Etanercept Biosimilar (YLB113) Receive PMDA’s Approval for Moderate-to-Severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis (JIA) in Japan

Lupin and YL Biologics’ Etanercept Biosimilar (YLB113) Receive PMDA’s Approval for Moderate-to-Severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis (JIA) in Japan

Shots:

  • The approval is based on global P-III trial results assessing etanercept biosimilar (YLB113) vs Enbrel in 500 patients with RA across 11 countries including Japan, EU and India, evaluating its efficacy and safety
  • In Mar,2018 Lupin ad YLB filled NDA based on above study results to Pharmaceutical and Medical Devices Agency (PMDA) in Japan
  • YLB113 is a biosimilar of Amgen’s Enbrel, targeted globally for severe autoimmune disorders including RA & JIA. Lupin also has two oncology biosimilars Lupifil (filgrastim) and Lupifil-P (peg-filgrastim)

Click here to read full press release/ article | Ref: Lupin | Image: VirtualStudio