Etanercept biosimilar confers the same disease activity as that of the originator in rheumatoid arthritis patients

According to a study published in Rheumatology, patients with rheumatoid arthritis (RA) who use an etanercept biosimilar exhibit the same disease activity and survival rates as patients who received the originator.

 Dr. Kearsley-Fleet and colleagues examined data from the British Society for Rheumatology Biologics Registry for RA to investigate the efficacy of the original etanercept compared to a biosimilar in patients with RA. Etanercept was initiated in 1806 biologic-naive RA patients, with 797 patients using the biosimilar and 1009 using the original medication. Data were collected on patient characteristics, disease activity and severity assessments, patient-reported outcomes, and functional ability scores. The patients were followed up for three years, and data were gathered every six months. The percentage of patients achieving DAS for 28-joints (DAS28) remission and a European Alliance of Associations for Rheumatology response at 6 and 12 months was comparable between the two therapies. About 19% of originator patients switched to an etanercept biosimilar during follow-up. Individuals receiving the original medication were equally likely as those on the biosimilar to continue their therapy, with 71% of patients on the originator and 76% on the biosimilar still receiving treatment after a year.

In 2017, a study was conducted to identify the characteristics of patients with rheumatoid arthritis (RA) who were prescribed biosimilars as their initial biologic therapy in the UK. The study aimed to evaluate the early usage of biosimilars and assess their effectiveness in patients with active disease. The study recruited 417 patients, of which 138 started biosimilar as the first biologic, 242 switched from a different biologic, and 37 switched directly from the original product. After a median (IQR) follow-up of 6.7 (3.0-9.5) years, patients who switched from the originator medication did so, and most of them had mild disease activity (median DAS28 2.7 (IQR 2.0-3.9)). The primary reason for switching was the cost for 33% of patients, while “trust policy” was mentioned in 63% of the 30 free-text comments. Data from 41 patients’ six-month follow-ups were available, and 18% (6/34) of patients showed a decline in their DAS28 score of >1.2 after six months. Among these, three patients on Remsima patients and one on Inflectra reported medication hypersensitivity events (rash, itching, hyperpigmentation).

These findings are encouraging and offer hope for improved access to biologic therapies for patients with rheumatoid arthritis. The evidence indicates that biosimilars are comparable to the original biologic medications in terms of efficacy and safety, offering potential cost savings. However, further research and evaluation are needed to confirm biosimilars’ long-term safety and effectiveness and identify any potential concerns or issues that may arise with their use.


  1. Kearsley-Fleet L, Rokad A, Tsoi MF, Zhao SS, Lunt M, Watson KD, BSRBR-RA Contributors Group, Hyrich KL. Etanercept originator versus etanercept biosimilar for the treatment of rheumatoid arthritis as a first biologic: results from the BSRBR-RA. Rheumatology. 2023 Mar 21:kead127.
  2. De Cock D, Watson K, Hyrich KL, BSRBR-RA Control Centre Consortium. FRI0196 Biosimilars in the UK: early real world data from the British society for rheumatology biologics registers for rheumatoid arthritis.