Patients with rheumatoid arthritis (RA) who switched from adalimumab (Humira) to its biosimilar, adalimumab-adbm (Cyltezo), saw no clinically meaningful difference in efficacy, safety or immunogenicity, according to the results of a 48-week Phase III clinical trial
The trial data was presented at the American College of Rheumatology / Association of Rheumatology Health Professionals Annual Meeting in San Diego, California by Boehringer Ingelheim, the manufacturers of Cyltezo.
The study, which aimed to assess equivalence in efficacy between the two drugs, comprised 645 patients aged 18 to 80 years with moderate-to-severely active RA on stable treatment with methotrexate. The patients were randomised to receive either adalimumab or its biosimilar, adalimumab-adbm, at 40mg every two weeks for 48 weeks.
At week 24, those patients receiving adalimumab were re-randomised to switch to the biosimilar or continue with adalimumab until week 48.
At week 48, it was found that adalimumab and its biosimilar had similar efficacy, safety and immunogenicity. In addition, those patients who switched at week 24 showed no difference to those who had continued with adalimumab.
“These data are an important addition to the robust body of evidence demonstrating Cyltezo is biosimilar to Humira,” said Karsten Kissel, head of global medical affairs biosimilars at Boehringer Ingelheim.
“Biosimilars have potential cost benefits to the healthcare system and support affordable access to important biologic medicines for patients living with chronic inflammatory diseases like RA,” he added.
In the European Union, adalimumab-adbm recently received positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency for multiple chronic inflammatory diseases in adults, including moderate to severely active RA; psoriatic arthritis; moderate to severely active Crohn’s disease; and moderate to severely active ulcerative colitis.
It is not currently commercially available in the United States.
 Cohen S, Alonso-Ruiz A, Klimiuk P et al. Biosimilar candidate BI 695501 and adalimumab reference product have similar efficacy and safety in patients with moderately-to-severely active rheumatoid arthritis (RA): 1-year results from phase III study. Abstract present at ACR, San Diego, 3–4 November 2017.