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Celltrion’s Humira biosimilar is comparable in treating rheumatoid arthritis

pharmafile | November 4, 2020 | News story | Research and Development Humira, biosimilar, celltrion, rheumatoid arthritis 

Celltrion has revealed new Phase 3 data demonstrating that its high concentration (100mg/mL) and citrate-free biosimilar CT-P17 proved comparable to its reference product, AbbVie’s best-selling Humira (adalimumab), in the treatment of rheumatoid arthritis (RA).

Revealed at the American College of Rheumatology (ACR) Convergence 2020, the findings compared Celltrion’s product to Humira in terms of efficacy, safety and pharmacokinetics. In the trial, 648 moderate-to-severe RA patients were randomly given either Celltrion or AbbVie’s drug fortnightly for 24 weeks.

It was found that both drugs generated the same proportion of ACR20 responses at 82.7% each, representing an improvement of at least 20% in patient symptoms. “Similar” rates were observed in the secondary goals of ACR20/50/70 response, average DAS28, clinical disease activity index and simplified disease activity index, and EULAR response.

“These Phase 3 results show a comparable PK, efficacy and safety profile between CT-P17 and the reference adalimumab, building on evidence demonstrating that CT-P17 is equivalent to reference adalimumab for the treatment of rheumatoid arthritis”, said Professor Edward Keystone, Senior Consultant Rheumatologist at Mount Sinai Hospital in Canada.  “These promising study results support the use of CT-P17, the first adalimumab biosimilar with high concentration and citrate-free formulation as an alternative option for eligible patients with rheumatoid arthritis.”

Matt Fellows

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