VOLTAIRE-X phase III data in patients with moderate-to-severe chronic plaque psoriasis support interchangeability application

- VOLTAIRE-X data showed that switching several times between Cyltezo® (adalimumab-adbm) and Humira® (adalimumab) resulted in similar pharmacokinetics, efficacy, immunogenicity, and safety in people with moderate-to-severe chronic plaque psoriasis

- At week 32, the study met the primary endpoint, supporting Cyltezo's® application as an interchangeable biosimilar to Humira® adalimumab reference product (RP)

- Data will be presented at the American Academy of Dermatology 2021

News provided by

Boehringer Ingelheim Pharmaceuticals, Inc.

Apr 23, 2021, 10:00 ET

RIDGEFIELD, Conn., April 23, 2021 /PRNewswire/ -- Boehringer Ingelheim today announced results from a phase III, randomized study that concluded that switching several times from Humira® (adalimumab) to Cyltezo® (adalimumab-adbm) produced similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity, and safety in people with moderate-to-severe chronic plaque psoriasis. The 32-week data will be presented at the American Academy of Dermatology 2021 virtual meeting experience.

"We are proud to present the results from Voltaire-X, a landmark study that supports Boehringer Ingelheim's application for interchangeability between Cyltezo® and Humira®," said Thomas Seck, Senior Vice President, Medicine and Regulatory Affairs at Boehringer Ingelheim. "This first-of-its-kind switching study further reinforces our goal to broaden access to biosimilar treatment options while contributing to the quality and sustainability of healthcare systems."

A biosimilar is a biological medicine that is developed to be highly similar to an approved reference biologic, with no clinically meaningful differences in terms of quality, safety, potency and purity. To be designated as an interchangeable product by the U.S. Food and Drug Administration (FDA), a biosimilar must also be "expected to produce the same clinical result as the reference product in any given patient" and "not present greater risks in terms of safety or diminished efficacy from alternating or switching" between the interchangeable candidate and reference product. A biosimilar with an interchangeable designation can be substituted by a pharmacist for the reference product without involving the prescriber, consistent with state law.

VOLTAIRE-X (NCT 03210259), a phase III, interchangeability study with the U.S.-marketed, original formulation of Humira®, 40mg/0.8mL, randomized 238 patients to assess the following:

Pharmacokinetic similarity between patients with moderate-to-severe chronic plaque psoriasis receiving Humira® continuously versus those who switched several times between Cyltezo® and Humira®
Comparison of the efficacy, immunogenicity, and safety profiles between patients receiving Humira® continuously versus those who switched several times between Cyltezo® and Humira®

Patients with moderate-to-severe chronic plaque psoriasis received Humira® and were then randomized to 'switching' or 'continuous' treatment. Baseline characteristics were generally balanced between groups. The data supports Cyltezo's® application for designation as an interchangeable biosimilar to Humira®, based on outcomes between the switching and continuous treatment groups, in pharmacokinetics, efficacy, immunogenicity, and safety.

These results continue to build on the existing analytical, pharmacological, non-clinical similarity data as well as the clinical data in Crohn's Disease and in the rheumatoid arthritis population, which were used to support the approval of Cyltezo® by the FDA in 2017.

Boehringer Ingelheim has submitted a supplemental biologics license application (sBLA) for Cyltezo® for designation as an interchangeable biosimilar to Humira®. The action date is scheduled for the 4th quarter of 2021.

Cyltezo® is not commercially available in the U.S. at this time, but its commercial license will begin on July 1, 2023.

About Boehringer Ingelheim in Biologics and Biosimilars

Boehringer Ingelheim is one of the largest producers of biologic medicines in the world, producing biologic medicines to support our diverse pipeline, as well as other companies' biopharmaceuticals on a contract basis. As a pioneer in biologics with more than 35 years of experience, the company's global biopharmaceutical business has received U.S. regulatory approvals for more than 35 complex biologic medicines in therapeutic areas that include oncology, immunology and rheumatology. More than 70 percent of the world's 20 leading pharmaceutical companies trust Boehringer Ingelheim to manufacture their proprietary biologic medicines on their behalf. For more information about Boehringer Ingelheim's Biopharma and manufacturing capabilities, please click here: https://www.boehringer-ingelheim.us/biopharma/biosimilars.

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

All public information on our clinical trials is available on: http://clinicaltrials.gov/.

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

About Cyltezo®

Cyltezo® was approved by the U.S. Food and Drug Administration (FDA) in August 2017 for the treatment of multiple chronic inflammatory diseases including rheumatoid arthritis, psoriasis and Crohn's disease.

Please see full Prescribing Information, including Medication Guide.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, with around 52,000 employees, we create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2020, Boehringer Ingelheim achieved net sales of around 22.33 billion USD (19.57 billion EUR). Our significant investment of over 4.2 billion USD (3.7 billion EUR) in 2020 (18.9% of net sales) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.