Boehringer Ingelheim announces resolution of Cyltezo® patent litigation

Ridgefield, Conn., May 14, 2019 – Boehringer Ingelheim today announced the resolution of all intellectual property-related litigation with AbbVie concerning Cyltezo® (adalimumab-adbm) and the reference medicine Humira® (adalimumab).

“We are proud of the role we play in raising public awareness of biosimilars and being able to stimulate competition to bring more affordable treatment options to U.S. patients,” said Sheila Denton, Senior Vice President and U.S. General Counsel, Legal & Government Affairs/Public Policy at Boehringer Ingelheim. “This resolution provides clarity regarding the availability of Cyltezo® and allows us to focus on serving patients who need to manage their chronic disease.”

The license period for Cyltezo®' will begin on July 1, 2023, a date that places Boehringer Ingelheim among the first companies to bring an alternative treatment option to Humira® to U.S. patients. Boehringer Ingelheim will pay royalties to AbbVie for licensing its Humira® patents once Cyltezo® is launched. The settlement relates to the U.S. only and specific terms are confidential between the companies.

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/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.

Boehringer Ingelheim has ongoing clinical trials for Cyltezo® including VOLTAIRE-X (NCT 03210259), 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/.

*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
Improving the health of humans and animals 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 2018, Boehringer Ingelheim achieved net sales of around 17.5 billion euros. R&D expenditure of almost 3.2 billion euros corresponded to 18.1 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 humankind and the environment.

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