Phase III trial of CHS 0214 (etanercept biosimilar) meets primary endpoint in rheumatoid arthritis- Coherus BioSciences and Baxalta

Coherus BioSciences and Baxalta have announced that CHS 0214, a proposed biosimilar of Enbrel (etanercept), met its primary endpoint in a confirmatory, double-blind, randomised, controlled, two-part clinical study. This ongoing study is evaluating the efficacy and safety of CHS-0214 compared to etanercept in patients with moderate-to-severe rheumatoid arthritis that is inadequately controlled with methotrexate alone. The study continues as planned until Week 52. The primary efficacy endpoint was the proportion of subjects achieving ACR20 (20% improvement according to the American College of Rheumatology criteria) at Week 24. The primary endpoint was within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to etanercept. There were no clinically meaningful differences in the safety and immunogenicity profiles of the two products.

This rheumatoid arthritis study is the second of two large Phase III confirmatory trials intended for inclusion in global marketing applications for CHS-0214. Results for the first Phase III study in patients with chronic plaque psoriasis were released in November 2015 and showed that this first study also met its primary endpoints.

Comment: Coherus joins a growing list of companies focusing on developing biosimilars of etanercept, with Biocon/Mylan, Celltrion, Mycenax, Samsung/Biogen Idec and Sandoz all having biosimilar versions in clinical development. India-based generics’ manufacturer Cipla also launched its ‘similar biologic’ product Etacept in April 2013, the first ‘similar biologic’ of etanercept in India. A ‘similar biotherapeutic product’ Etanar has also been approved in Colombia.