This week, Boehringer Ingelheim announced results from a 16-week phase 3 study that confirmed biosimilar adalimumab-adbm (to be sold as Cyltezo) was clinically equivalent to the reference product, Humira.
This week, Boehringer Ingelheim (BI) announced results from a 16-week phase 3 study that confirmed biosimilar adalimumab-adbm (to be marketed as Cyltezo) was clinically equivalent to the reference product, Humira.
The phase 3 study enrolled 318 patients between 18 and 78 years of age with moderate-to-severe chronic plaque psoriasis who were biologic naïve. Researchers randomized the patients to receive adalimumab-abdm or the reference product at 80 mg on day 1, 40 mg on day 7, and 40 mg every other week thereafter.
The primary endpoint, which was achieved, measured the number of patients who achieved a 75% reduction in the Psoriasis Area and Severity Index (PASI) score at week 16. Additionally, the trial confirmed that there were no clinically meaningful differences in efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis.
“The phase 3 study builds on recent evidence that demonstrates Cyltezo is equivalent to Humira for the treatment of moderately to severely active rheumatoid arthritis. these data reinforce the robust body of evidence that Boehringer Ingelheim is collecting to provide safe and effective treatment options that will contribute to the quality and sustainability of healthcare systems,” Key Tetzlaff, vice president and Medical Head of Therapeutic Area Biosimilars at BI, said in a statement.
Adalimumab-adbm, which was approved by the FDA last year, has yet to become commercially available in the United States as BI is currently engaged in patent litigation with reference product developer, AbbVie. Additionally, BI is currently conducting a clinical trial looking to demonstrate interchangeability between adalimumab-adbm and the reference product. This is the first interchangeability study of its kind in the United States, as the FDA has yet to finalize the guidelines around demonstrating and achieving an interchangeability designation. A final guidance is expected to be issued on or before May 2019.
Additional data from the 24-week study are expected to be presented next year.