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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

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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

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  • 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


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