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Boehringer Ingelheim completes biosimilar adalimumab trial

Biosimilars/Research | Posted 12/10/2012 2 Post your comment

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].

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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

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Source: Boehringer Ingelheim, ClinicalTrials.gov

Comments (2)

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Posted 06/06/2013 by Dr Michelle D, GaBI Online Editorial Office

Response to ‘Boehringer Ingelheim completes biosimilar adalimumab trial’

Dear Dr Appel,
I would suspect that it’s done in this way so the trial can support both EU and US submissions, as the regulators normally request that the reference product is authorized in that country/region and the clinical trial(s) is carried out in that same country/region. I would hope that the two groups would give the same results – we will only see when the results are published.
Thank you and regards,
Michelle

Posted 12/10/2012 by Alan M Appel, PhD

Boehringer Ingelheim completes biosimilar adalimumab trial

Thanks so much for your newsletter in general and for this posting in particular. :-)

In reading this posting, you noted that the study had 2 identically dose adalimumab treatment groups, which seemed intriguing to me.

But, of course, as per clintrials.gov, you are correct !!!

The clintrials site lists 1 adalimumab group is from EU and one is from US.

Do you have any insight as to why the study was carried out in that way?

Do we know the source of the adalimumab preparations, apart from 1 being EU and 1 from US ?

Presumably BI will report the results for each adalimumab group separately--otherwise why would they list the treatment separately ? But shouldn't both groups give the same results?

I appreciate that the author is only reporting here and not directly associated with the trial.

But I hope you can answer at least a few of my questions !!!

For reference, the clintrials link I used for the trial is found below:
http://clinicaltrials.gov/ct2/show/NCT01505491?term=BI+695501&rank=1

All the best,

Alan M Appel, PhD