Samsung Biogen Launches Imraldi (adalimumab, biosimilar) in EU for 14 Autoimmune Conditions

 Samsung Biogen Launches Imraldi (adalimumab, biosimilar) in EU for 14 Autoimmune Conditions

Samsung Biogen Launches Imraldi (adalimumab, biosimilar) in EU for 14 Autoimmune Conditions

Shots:

  • The EU approval is based on two head-to-head P-I study for PK biosimilarity & P-III evaluating efficacy and safety assessing Imraldi vs Humira (40mg/0.8 ml) in patients with moderate-to-severe RA
  • P-III study results: ACR20 @24wks (72.5% vs 72.0%); with comparable efficacy, safety & immunogenicity. Humira’s biosimilar is approved and indicated in RA, juvenile idiopathic arthritis, axSpA, PsA, psoriasis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, CD & UC in EU
  • In 2017, Biogen was first company in EU with three approved biosimilars i.e Benepalitm (etanercept, Enbrel), Flixabitm (infliximab, Remicade) & Imraldi as anti-TNF biologic treatments in 25 and 14 countries respectively

Click here to read full press release/ article | Ref: Biogen | Image: Market Watch

Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on shiwani@pharmashots.com

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