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Boehringer Ingelheim. (9/12/18). "Press Release: Biosimilar Cyltezo Demonstrates Clinical Equivalence to Humira in Patients with Moderate-to-Severe Plaque Psoriasis". Ingelheim.

Organisations Organisation Boehringer Ingelheim (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product Cyltezo™ (biosimilar adalimumab-adbm to Humira)
  Product 2 Humira®
     


> Data show that Cyltezo© (adalimumab- adbm) and Humira®* have similar efficacy, safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis1

> At week 16, the study met the primary endpoint, demonstrating clinical equivalence to Humira®1

> Data will be presented at the European Association of Dermatology and Venereology Annual Meeting (EADV 2018)


Boehringer Ingelheim today 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 will be 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 randomised 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% 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 European Commission and the U.S. Food and Drug Administration (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.


About Plaque Psoriasis

Plaque psoriasis is an autoimmune disease characterised by dry, red skin lesions which are covered in silver scales.2 Plaque psoriasis is the most common form of psoriasis, accounting for approximately 80% of all reported cases.3 Worldwide, plaque psoriasis affects approximately 125 million people,4 including almost 14 million Europeans.5 Common sites of the disease include elbows, knees, scalp and lower back, but affected areas can appear anywhere on the body.6

About Boehringer Ingelheim in Biologics and Biosimilars
Boehringer Ingelheim is one of the largest manufacturer of biologic medicines in the world. As a pioneer in biologics with more than 35 years of experience, the company has manufactured more than 25 biologic medicines for global markets, this includes monoclonal antibodies in immunology and oncology, interferons, and other targeted medicines that are routinely used to treat many patients across a broad range of therapeutic areas.

Boehringer Ingelheim further builds on its commitment to immunology and oncology to develop biosimilars as high quality, safe, and effective treatment options to patients with autoimmune diseases and cancer.

Boehringer Ingelheim has ongoing clinical trials for Cyltezo® including VOLTAIRE-X, an interchangeability study with the U.S.-marketed formulation of Humira®, 40mg/0.8mL.

All public information on our clinical trials is available on: http://clinicaltrials.gov/ (link is external).


Boehringer Ingelheim

Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales.

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.boehringer-ingelheim.com.


Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
Footnotes


* HUMIRA® is a registered trademark of AbbVie Biotechnology Ltd.


References

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.

2 National Psoriasis Foundation, ‘About Psoriasis’. Available at: https://www.psoriasis.org/about-psoriasis. Accessed August 2018.

3 American Academy of Dermatology, ‘Psoriasis’. Available at: https://www.aad.org/media/stats/conditions/psoriasis. Accessed August 2018.

4 International Federation of Psoriasis Associations. World Psoriasis Day. Available at: https://ifpa-pso.com/our-actions/world-psoriasis-day/. Accessed August 2018.

5 Ortonne JP and Prinz JC. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. European Journal of Dermatology. 2004; 14(1):41-45.

6 NHS Choices, ‘Psoriasis’. Available at: http://www.nhs.uk/Conditions/Psoriasis/Pages/Introduction.aspx. Accessed August 2018.


Media Contact

Dr Julia Faaß
Media & PR
Phone +49 6132 77 95614
Fax +49 6132 77 6601
Binger Strasse 173
55216 Ingelheim am Rhein
GERMANY

   
Record changed: 2018-09-21

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