Etanercept is a soluble TNF receptor fusion protein that abrogates the pro-inflammatory effects of TNF signalling.
As a biosimilar medicine, Benepali was shown to be comparable to the reference etanercept product, Enbrel, in terms of quality, biological activity, structural characteristics, safety and efficacy.
Clinical equivalence of Benepali to Enbrel was demonstrated in a double-blind, phase III study in 596 patients with moderate to severe active rheumatoid arthritis despite methotrexate therapy. Participants were randomised to receive Enbrel or Benepali 50mg once weekly for up to 52 weeks.
Analysis of the per-protocol population showed an ACR20 response rate at 24 weeks (primary endpoint) of 78.1% in the Benepali arm and 80.3% in the Enbrel arm, meeting the predefined criterion for therapeutic equivalence. The safety profile of Benepali was comparable to that of Enbrel.
"For more than 15 years anti-TNF therapies have revolutionized the care and outlook for patients living with chronic inflammatory diseases such as RA. However, access to these highly-effective treatments has been restricted by high costs," said Professor Peter Taylor, Norman Collisson Professor of Musculoskeletal Sciences, Kennedy Institute of Rheumatology, University of Oxford.
"The development of biosimilar drugs is a welcome solution to help alleviate some challenges with access. The newly-approved treatment Benepali has similar quality, efficacy, and a comparable safety and immunogenicity profile to Enbrel."
Biosimilar medicines should be prescribed by brand, according to MHRA advice.