South Korea’s biosimilar leader Celltrion presented positive top-line efficacy and safety results for CT-P17, the first biosimilar with high concentration and citrate-free formulation of reference Humira (adalimumab) at the American College of Rheumatology (ACR) Convergence 2020 held on Nov. 6-7, the company said on Sunday.

Data from a Phase 1 study showed comparable pharmacokinetics (PK) and safety data for CT-P17 versus adalimumab in rheumatoid arthritis (RA). The company also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS).

In a Phase 3 study designed to evaluate the equivalence of CT-P17 to adalimumab in terms of efficacy, PK and overall safety over 24 weeks in patients with active moderate-to-severe RA, CT-P17 demonstrated comparable efficacy, PK and safety.

The EU-approved and US-licensed adalimumab is a blockbuster biologic with sales of $19.16 billion worldwide last year. Celltrion completed a BLA submission in Europe for CT-P17 in March based on its comparable data for Humira’s entire indications including RA, ulcerative colitis and psoriasis.

By Park Yoon-gyun and Minu Kim

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