Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

Biosimilar Cyltezo Demonstrates Clinical Equivalence to Humira

By Boehringer Ingelheim Pharmaceuticals | September 14, 2018

Boehringer Ingelheim announced results from a phase III study, confirming that Cyltezo is equivalent to Humira, with no clinically meaningful differences in efficacy, safety, and immunogenicity in people with moderate-to-severe chronic plaque psoriasis.1 The 16-week data was presented at the European Association of Dermatology and Venereology Annual Meeting (EADV 2018) in Paris.

“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 Kay 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.

These clinical data in the psoriasis population continue to build on the strong existing analytical, pharmacological, non-clinical similarity data as well as the clinically similar data in the rheumatoid arthritis population, which were used to support the approval of Cyltezo by the U.S. FDA. In addition, Boehringer Ingelheim is conducting a clinical trial to demonstrate the interchangeability between Cyltezo and Humira.

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

Citrate-free Cyltezo is not commercially available in the U.S. at this time. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie in the U.S.

Reference

1 Menter A, et al. Biosimilar BI 695501 and Adalimumab Reference Product have Similar Efficacy and Safety in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: 16-week Results from a Phase III Study. Abstract presented at European Association of Dermatology and Venereology Annual Meeting (EADV 2018), Paris, September 12-16 2018.  

(Source: Boehringer Ingelheim Pharmaceuticals, Inc.)


Filed Under: Drug Discovery

 

Related Articles Read More >

Diversity
Making diversity in clinical research more than a talking point
psychedelic medicine discussed at SXSW
5 headwinds and 5 tailwinds for psychedelic medicine
lab microscope
Accelerating R&D with FAIR data
Kallyope
Kallyope’s focus on the gut-brain axis yields a diverse portfolio

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Medtech100 Index
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50