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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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