Biopharmaceutical specialist Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) has completed its phase I trial for a biosimilar version of adalimumab.
The phase I trial studied the safety and pharmacokinetics of Boehringer Ingelheim’s biosimilar (BI 695501) compared to Abbott Laboratories blockbuster arthritis and psoriasis treatment Humira (adalimumab). The trial was a randomized, open label, parallel arm, single dose, active comparator trial and consisted of three groups of patients, one of which received the biosimilar and two of which received Humira. All patients received one subcutaneous injection of either BI 695501 or 40 mg of Humira via a prefilled syringe.
The purpose of the trial was to investigate the pharmacokinetics, safety and tolerability of Boehringer Ingelheim’s biosimilar (BI 695501) and to establish pharmacokinetic equivalence of the biosimilar to Humira (adalimumab) in healthy subjects.
The primary evaluation of the drugs was based on the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity and the maximum measured concentration of the analyte in plasma, both measured over 72 days.
The safety and pharmacokinetics study was carried out in New Zealand and included healthy male adults aged 18 to 55 years. The study started in December 2011 and was expected to be completed in July 2012. According to ClinicalTrials.gov, the study is now completed, however, as yet Boehringer Ingelheim has announced no results.
Germany-based Boehringer Ingelheim announced back in September 2011 that it would create a dedicated division for the development and commercialization of biosimilars [1] and has also started a phase III trial for a biosimilar of Roche’s blockbuster cancer and arthritis treatment Rituxan (rituximab) [2].
Related articles
Boehringer Ingelheim starts biosimilar rituximab trial
Boehringer Ingelheim acquires Amgen biotech site
Reference
1. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim joins other Big Pharma going into biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 12]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-joins-other-Big-Pharma-going-into-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim starts biosimilar rituximab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Oct 12]. Available from: www.gabionline.net/Biosimilars/Research/Boehringer-Ingelheim-starts-biosimilar-rituximab-trial
Permission granted to reproduce for personal and educational use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Source: Boehringer Ingelheim, ClinicalTrials.gov
2
Post your comment