Boehringer Ingelheim Announces Completed Enrollment of Phase III Clinical Trial for Biosimilar Candidate to Adalimumab
- Phase III clinical trial for BI695501, a biosimilar candidate for AbbVie’s Humira®, fully enrolled
- Recently announced Phase I trial results show pharmacokinetic bioequivalence of BI695501 to U.S.-licensed and EU-approved adalimumab reference products1A
- First scientific data presentation for a Boehringer Ingelheim biosimilar compound at the ACR/ARHP Annual Meeting
Ingelheim, Germany, November 10, 2015 — Boehringer Ingelheim today announced it has completed enrollment for the pivotal Phase III trial (NCT02137226) of BI695501, a biosimilar candidate to adalimumab (AbbVie’s Humira®). This announcement was made following recent results from a Phase I trial that demonstrated pharmacokinetic bioequivalence with both the U.S.-licensed and EU-approved reference products.1A These Phase I data for BI695501 were discussed today at the American College of Rheumatology / Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in San Francisco.
Vice President and
Head, Clinical
Development and
Medical Affairs
Biosimilars,
Boehringer Ingelheim
The Phase III clinical trial is a randomized, double-blind, parallel arm, multiple dose, active comparator trial in patients2A who have been diagnosed with moderate to severe rheumatoid arthritis and are currently being treated with methotrexate.2B Each participant is randomized to receive either BI695501 or the U.S.-licensed reference product every two weeks for 48 weeks.2C
“We are excited to reach this important milestone for BI695501, which brings us closer to our goal of delivering new options to patients through our investigational biosimilars portfolio,” said Sandeep Athalye, MD, Vice President and Head, Clinical Development and Medical Affairs Biosimilars, Boehringer Ingelheim. “Our long-term commitment is to become a global leader in biosimilars, thereby supporting access to biologic medicines around the world.”
Results for the completed Phase I study for adalimumab were announced on October 28.
About Boehringer Ingelheim in Biologics
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 brought more than 20 biologic medicines to patients around the world.3 Boehringer Ingelheim is committed to becoming a global leader in biosimilars and increasing the availability of high quality biologics.
About Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is a chronic inflammatory autoimmune disease affecting synovial joint lining; causing pain, stiffness, swelling and limited motion and function of joints.4 In many patients, the progressive destruction of joints may ultimately result in disability. Three times as many women are affected by RA compared to men. RA affects approximately 23.7 million people worldwide5 and 1.6 million people in the United States.6,7 It can develop at any time during adulthood, but it usually occurs between 40 and 70 years of age.8
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.
For more information please visit www.boehringer-ingelheim.com
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Referências
- Wynn C et al. BI 695501, a proposed biosimilar for adalimumab, shows bioequivalence to adalimumab reference products in a randomized, double-blind phase I study in healthy subjects. Abstract accepted at the 2015 American Association of Pharmaceutical Scientists Annual Meeting; Oct 25-29, 2015; Orlando, Florida. Abstract W4286. Available at https://annual.aapsmeeting.org/poster/member/43254. Accessed October 2015.
- BI695501 compared to adalimumab in patients with active rheumatoid arthritis. Clincialtrials.gov web site. Available at: https://clinicaltrials.gov/ct2/show/NCT02137226?term=695501&rank=2. Accessed October 2015.
- Boehringer Ingelheim. (January 2015). Producing Value: Global Contract Manufacturing Excellence [Brochure].
- Medline Plus, “Rheumatoid Arthritis” Accessed 11 October 2011. Available at http://www.nlm.nih.gov/medlineplus/ency/article/000431.htm
- World Health Organization, “The Global Burden of Disease, 2004 Update.” Accessed 13 March 2012. Available at http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf?ua=1
- Sacks, J., Lou, Y., Helmick, C. Prevalence of Specific Types of Arthritis and Other Rheumatic Conditions in the Ambulatory Health Care System in the United States 2001-2005. Arthritis Care and Research. 2010. 62(4): 460- 464.
- Howden, L., Meyer, J., 2010 U.S. Census Bureau results --- U.S. Census Bureau, 2010 Census Summary File.
- Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001; 358:903-911.