Boehringer Ingelheim starts clinical study on interchangeability between its adalimumab biosimilar candidate and U.S.-formulated Humira®

- First patient enrolled into VOLTAIRE-X; an interchangeability study designed to assess whether BI 695501 is interchangeable with Humira®

- First study in the U.S. to investigate an interchangeability designation for an adalimumab biosimilar candidate

- BI 695501 is currently under review by regulatory authorities

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Boehringer Ingelheim Pharmaceuticals, Inc.

Jul 27, 2017, 09:56 ET

RIDGEFIELD, Conn., July 27, 2017 /PRNewswire/ -- Boehringer Ingelheim announced today that the first patient has been enrolled into its VOLTAIRE-X interchangeability study. The goal of the study is to demonstrate that BI 695501 is interchangeable with the U.S.-marketed formulation of Humira^®* 40 mg/0.8 ml. This is the first study in the U.S. to investigate an interchangeability designation for an adalimumab biosimilar candidate.

The study will compare the pharmacokinetics and clinical outcomes between patients receiving Humira^® continuously, versus those who switch repeatedly between Humira^® and BI 695501, Boehringer Ingelheim's adalimumab biosimilar candidate. The study will also assess safety, immunogenicity and efficacy.

"We are pleased that the first patient has now been enrolled in VOLTAIRE-X, and look forward to continued recruitment and patient follow-up," said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. "The initiation of this study reinforces our commitment to improving the lives of patients suffering from serious chronic or life-threatening diseases through biosimilars. With biosimilars, we will have the opportunity to expand treatment options while at the same time providing value to the healthcare system."

The VOLTAIRE-X study (NCT03210259), is being conducted in 240 patients with moderate-to-severe chronic plaque psoriasis. Results from the study are expected in the second half of 2019.

BI 695501 has been accepted for regulatory review by the European Medicines Agency and the U.S. Food and Drug Administration. Phase III results demonstrating clinical equivalence of BI 695501 to Humira^® in people living with rheumatoid arthritis were recently presented at the annual European Congress of Rheumatology.

About Interchangeability
As per the U.S. Food and Drug Administration, an interchangeable biologic is a biosimilar that produces the same clinical result as its reference product in any given patient. Interchangeability is a designation by the FDA that means a biosimilar may be substituted by a pharmacist for the reference product without the intervention of the healthcare provider who wrote the prescription, subject to individual state law. More than half of the U.S. have either passed or are considering state laws regarding automatic substitution of biologics.

About Plaque Psoriasis
Plaque psoriasis is an autoimmune disease characterised by dry, red skin lesions which are covered in silver scales. Accounting for approximately 80% of cases it is the most common form of psoriasis. Common sites of the disease include elbows, knees, scalp and lower back, but affected areas can appear anywhere on the body.

About Boehringer Ingelheim in Biologics and Biosimilars
Boehringer Ingelheim is one of the largest producers 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. For more information about Boehringer Ingelheim's Biopharma and manufacturing capabilities, please click here https://www.boehringer-ingelheim.us/our-focus/biopharma/fremont

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 currently has two biosimilar monoclonal antibodies in late stage development: BI 695501, adalimumab biosimilar candidate to Humira^® and BI 695502, bevacizumab biosimilar candidate to Avastin^®.* All public information on our clinical trials is available on: http://clinicaltrials.gov/.

*Humira^® is a registered trademark of AbbVie, Inc. and Avastin^® is a registered trademark of Genentech, Inc. (USA).

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and about 50,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.

For more information please visit https://www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.