Boehringer Ingelheim bevacizumab biosimilar candidate demonstrates bioequivalence to Avastin®
RIDGEFIELD, Conn., Nov. 16, 2016 /PRNewswire/ -- Boehringer Ingelheim today announced new data from the Phase I INVICTAN®-1 study, which show that BI 695502, its bevacizumab biosimilar candidate, is bioequivalent to U.S.-licensed and EU-approved Avastin®.* Avastin® is an angiogenesis inhibitor that is used to treat a variety of cancers.
BI 695502 met all the pre-defined primary and secondary endpoints in the INVICTAN®-1 study. These data were presented in a poster at the American Association of Pharmaceutical Scientists Annual Meeting in Denver, CO, November 13 – 17.
"This study is an important milestone for Boehringer Ingelheim, and supports our commitment to improving the lives of patients with cancer by exploring innovative ways for biosimilars to contribute to the long-term sustainability of the U.S. healthcare system," said Martina Flammer, Vice President, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. "We look forward to evaluating BI 695502 in our ongoing Phase III study to establish its safety and efficacy as compared to Avastin."
About BI 695502 and INVICTAN®BI 695502, a bevacizumab biosimilar candidate to Avastin®, is a monoclonal antibody that may slow or stop the growth of certain tumor types by preventing the growth of blood vessels that supply the tumor.
INVICTAN®-1 (NCT01608087) is a randomized, blinded, single-dose, parallel-arm Phase I clinical study, evaluating bioequivalence (how a drug is absorbed, distributed, metabolized and excreted in the body) of BI 695502 to Avastin®. The study enrolled 91 healthy male individuals who were randomized evenly across treatment groups. BI 695502 was well-tolerated in this study, with no clinically relevant differences in safety or immunogenicity evaluations between the BI 695502 and bevacizumab treatment groups.
INVICTAN®-2 (NCT02272413) is a randomized, double-blind Phase III study, evaluating efficacy and safety of BI 695502 plus chemotherapy versus Avastin® plus chemotherapy in patients with advanced non-squamous non-small cell lung cancer.
About Boehringer Ingelheim in Biologics and BiosimilarsBoehringer 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 clinical 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/.
*Avastin® is a registered trademark of Genentech, Inc. (USA) and Humira® is a registered trademark of AbbVie, Inc.
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 more than 47,000 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.
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SOURCE Boehringer Ingelheim Pharmaceuticals