Samsung Bioepis and Organon’s Hadlima (biosimilar, adalimumab) Receive Health Canada’s Approval
- Health Canada has approved Hadlima, a high-concentration, citrate-free adalimumab biosimilar referencing Humira for RA, polyarticular JIA, AS, PsA, Crohn’s disease, UC, hidradenitis suppurativa, PsO, uveitis. Hadlima HC was developed through a commercialization agreement b/w Samsung Bioepis & Organon
- The approval was based on the P-I trial evaluating PK, safety & tolerability of the new SB5 formulation (40mg/0.4mL) vs prior SB5 formulation (40mg/0.8mL) in healthy male patients
- The study showed PK equivalence b/w new SB5 & prior SB5 formulation & both formulations were well tolerated with similar safety profiles. Hadlima will also be commercialized by Organon in 2023
Ref: Globenewswire | Image: Samsung Bioepis
Related News:- Samsung Bioepis and Organon’s Hadlima (biosimilar, adalimumab) Receive the US FDA’s Approval for Chronic Autoimmune Diseases
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