BI Announces 1-Year Data on Adalimumab Biosimilar, Cyltezo

At this week’s American College of Rheumatology 2017 Annual Meeting, Boehringer Ingelheim (BI) announced 1-year data from the VOLTAIRE-RA trial, which showed that BI’s newly approved adalimumab biosimilar (Cyltezo) showed no clinically meaningful differences in safety, efficacy, or immunogenicity from the reference adalimumab (Humira) in patients who had moderate to severe rheumatoid arthritis (RA).

The study included 645 patients, aged 18 to 80 years, whose RA was stable on treatment with methotrexate. Patients were randomized to receive either the reference adalimumab or the biosimilar at 40 mg every 2 weeks for 48 weeks.

At week 24, patients taking the reference drug (n = 148) were re-randomized to either switch to the biosimilar or remain on the reference until week 48. The 48-week data showed that the biosimilar is equivalent, with no clinically meaningful differences in efficacy, safety, or immunogenicity from the reference, including in patients who switched to the biosimilar at week 24.

“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 BI. “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.”

The VOLTAIRE clinical program also includes studies in patients with plaque psoriasis and Crohn’s disease, and includes VOLTAIRE-X, an interchangeability study with US-sourced Humira, as well as VOLTAIRE-AI, a study assessing delivery of the biosimilar in an auto-injector device.

BI’s biosimilar is not yet commercially available in the United States; BI is engaged in ongoing litigation with AbbVie, maker of Humira, over patents covering adalimumab. Once the patent dispute has been resolved, BI will join Amgen in bringing a biosimilar adalimumab to market; Amgen announced in September that it had reached a settlement with AbbVie, allowing it to begin marketing its biosimilar product in the United States in January 2023.