Boehringer Ingelheim Biosimilar Candidate To Humira® Accepted For EMA And FDA Regulatory Review

• BI 695501 EMA and FDA applications are first biosimilar regulatory filings for Boehringer Ingelheim
• Applications are supported by a comprehensive data package comprised of analytical, pre-clinical & clinical development studies

Ridgefield, CT /PRNewswire/ - Boehringer Ingelheim announced today that BI 695501, its adalimumab biosimilar candidate to Humira®^*, has been accepted for regulatory review by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

"The acceptance of our regulatory filings by the FDA and EMA is a critical milestone as we explore innovative ways for biosimilars to expand overall treatment options and seek to improve the lives of patients with chronic and life-threatening diseases," said Martina Flammer, Vice President, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. "If approved, we believe BI 695501 can offer a high quality, economically sustainable treatment option to patients with inflammatory diseases in the U.S."

Boehringer Ingelheim is seeking approval for BI 695501 as a biosimilar to Humira® in the European Union and the United States. Adalimumab is a monoclonal antibody that blocks TNF-α, an important mediator of inflammation in the human body. Adalimumab is approved as a biologic medicine under the brand name Humira® in many countries for the treatment of multiple chronic inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease, and psoriasis. These disorders collectively affect the lives of 5-10% of the world population including 23.5 million people in the U.S. and approximately 36.3 million people in Europe.

Top-line results from the completed Phase III study for BI 695501 in patients with active rheumatoid arthritis were announced on October 26, 2016.

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 oncology and immunology, 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 oncology and immunology to develop biosimilars as high quality, safe, and effective treatment options to patients with cancer and autoimmune diseases.

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/.

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.

^*Humira® is a registered trademark of AbbVie Biotechnology Ltd. in the EU/U.S. and Avastin® is a registered trademark of Genentech, Inc. (U.S.).