“This phase III study builds on recent evidence that demonstrates Cyltezo^® is equivalent to Humira^® for the treatment of moderately-to-severely active rheumatoid arthritis,” said Key Tetzlaff, vice president and medical head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “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.”

In the phase III study (NCT 02850965), 318 patients between 18 and 78 years of age with moderate-to-severe chronic plaque psoriasis, who had not previously received treatment with one or more biologic, were randomized to receive Cyltezo^® or Humira^® at 80 mg on day 1, 40 mg on day 7 and 40 mg every other week thereafter. The primary endpoint, which measured the proportion of patients achieving a 75 percent reduction in PASI (Psoriasis Area and Severity Index) at week 16, was met. The 24-week data from this study are expected to be presented next year.

This is the first study in the U.S. to investigate an interchangeability designation for an adalimumab biosimilar.