Boehringer Ingelheim’s Biosimilar Candidate Demonstrated Pharmacokinetic Bioequivalence to Adalimumab

  • Phase I trial evaluated pharmacokinetic and safety similarity of Boehringer Ingelheim adalimumab compound to both U.S.-licensed and EU-approved reference products, AbbVie’s Humira®1A
  • Phase I clinical trial results for Boehringer Ingelheim’s adalimumab compound shared at AAPS Annual Meeting
  • First scientific data presentation for a Boehringer Ingelheim biosimilar compound at the AAPS Annual Meeting

BRACKNELL, England--()--Boehringer Ingelheim today announced results from a Phase I study (NCT02045979) of its biosimilar candidate (BI695501) for adalimumab (AbbVie’s Humira®), that demonstrated pharmacokinetic bioequivalence with both the U.S.-licensed and EU-approved reference products.1A

“Boehringer Ingelheim is a pioneer in biotechnology with a long-standing history of more than 35 years; as a logical next step biosimilars are an important new area of focus for us.”

These data were presented in a poster at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting.

Professor Klaus Dugi, Medical Director, Boehringer Ingelheim UK & Ireland said,

“This is an important step towards our ultimate goal of providing new biosimilar therapeutic options to health care providers and patients.”

“Boehringer Ingelheim is a pioneer in biotechnology with a long-standing history of more than 35 years; as a logical next step biosimilars are an important new area of focus for us.”

The Phase I trial was a randomized, double-blind, single dose, parallel-arm study in healthy individuals: 1B

  • 327 healthy males between the ages of 18 and 55 participated
  • Each participant was randomized to receive one subcutaneous dose (40mg/0.8mL) of either BI695501, U.S.-licensed or EU-approved adalimumab 1C

The study found that safety, tolerability and immunogenicity were comparable among the treatment groups.1D

ENDS

About Boehringer Ingelheim in 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 brought more than 20 biologic medicines to patients around the world.1 Boehringer Ingelheim is committed to becoming a global leader in biosimilars and increasing the availability of high quality biologics.

About 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

1 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 health subjects. Abstract accepted at the 2015 American Association of Pharmaceutical Scientists Annual Meeting; Oct 25-29, 2015; Orlando, Florida. Abstract W4286. https://annual.aapsmeeting.org/poster/member/43254. Accessed October 3, 2015.

2 Boehringer Ingelheim. (January 2015). Producing Value: Global Contract Manufacturing Excellence [Brochure].

Contacts

Boehringer Ingelheim Pharmaceuticals, Inc.
Corporate Affairs Manager
Jonathan Fox
Phone: +44 (1344) 74-1675
Email: jonathan.fox@boehringer-ingelheim.com

Release Summary

Boehringer Ingelheim’s Biosimilar Candidate Demonstrated Pharmacokinetic Bioequivalence to Adalimumab