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

Ref: Biogen | Image: Biogen