Boehringer Ingelheim has revealed one-year data from VOLTAIRE-RA, a pivotal phase 3 clinical trial evaluating Cyltezo (adalimumab-adbm) with reference product Humira.
The 48-week data showed that Cyltezo is equivalent, with no clinically meaningful differences in efficacy, safety and immunogenicity to Humira in people with moderately-to-severely active rheumatoid arthritis (RA), including in patients who switched from Humira to Cyltezo at week 24.1
“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.”
“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 product.”
These data will be presented at the American College of Rheumatology / Association of Rheumatology Health Professionals Annual Meeting in San Diego, California.
In the EU, Cyltezo recently received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for multiple chronic inflammatory diseases including, in adults:
Moderate to severely active rheumatoid arthritis
Moderate to severely active Crohn’s disease
Severe active ankylosing spondylitis
Moderate to severely active ulcerative colitis
Severe axial spondyloarthritis without radiographic evidence of AS
Moderate to severe chronic plaque psoriasis
Moderate to severe hidradenitis suppurativa
Non-infectious intermediate, posterior and panuveitis.
The CHMP also recommended approval of Cyltezo for the treatment of paediatric inflammatory diseases, including moderate to severe Crohn’s disease (age six and older), severe chronic plaque psoriasis (age four and older), enthesitis-related arthritis (age six and older) and polyarticular juvenile idiopathic arthritis (age two and older).
Cyltezo is not commercially available in Europe or the U.S. at this time. In any event Boehringer Ingelheim does not intend to launch Cyltezo in the EU before expiration of the respective SPC for adalimumab in October 2018. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie in the U.S.