Phase 3 Data Suggest Humira Biosimilar Safe, Effective

Boehringer Ingelheim recently announced findings from the 1-year phase 3 VOLTAIRE-RA clinical trial, which compared adalimumab-adbm (Cyltezo) against adalimumab (Humira) in patients with rheumatoid arthritis (RA).

These results were presented at the American College of Rheumatology (ACR) Annual Meeting.

The data showed that adalimumab-adbm was equivalent to its reference product and had no meaningful differences in safety and immunogenicity among patients with RA, according to a press release.

Notably, switching data also suggests that the biosimilar is safe and effective.

“These data are an important addition to the robust body of evidence demonstrating Cyltezo is biosimilar to Humira,” said Karsten Kissel, MD, 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.”

Included in the clinical trial were 645 patients with moderate-to-severe RA who were receiving treatment with methotrexate. Patients were randomized to receive adalimumab-adbm or adalimumab 40-mg every 2 weeks for 48 weeks.

The primary objective of the study was to evaluate the efficacy of both drugs, measured by the number of patients achieving ACR20 criteria at weeks 12 and 24, according to Boehringer.

At week 24, patients treated with the reference product were randomized to continue therapy or switch to the biosimilar until week 48.

The authors also investigated other efficacy measures, safety, and immunogenicity of the treatments, according to the release.

Overall, the results suggest that switching to adalimumab-adbm from reference adalimumab may be safe and effective for patients with RA, according to Boehringer Ingelheim.

The biosimilar is currently approved to treat RA, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. However, Boehringer reports that the drug had yet to hit the market due to patent litigation with adalimumab’s manufacturer.

“In addition to the 48-week efficacy results, the adalimumab biosimilar Cyltezo showed equivalent safety and immunogenicity to Humira,” said Stanley B. Cohen, MD, Metroplex Clinical Research Center, Presbyterian Hospital, Dallas, Texas. “Consistent results were also demonstrated when patients were switched to Cyltezo from the reference prod