Positive phase I results for adalimumab biosimilar

Biosimilares/Investigación | Posted 06/11/2015 post-comment0 Post your comment

In an announcement on 28 October 2015, biopharmaceutical specialist Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) claimed that results from a phase I study of its adalimumab biosimilar (BI 695501) had ‘demonstrated pharmacokinetic bioequivalence’ to Humira (adalimumab).

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The phase I trial (NCT02045979) studied the pharmacokinetics, safety and tolerability of Boehringer Ingelheim’s biosimilar (BI 695501) compared to Abbott Laboratories’ blockbuster arthritis and psoriasis treatment Humira (adalimumab). The trial was a randomized, double-blind, 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 (sourced from either the US or the EU). All patients received one subcutaneous injection of 40 mg/0.8 mL of either BI 695501 or Humira via a pre-filled syringe.

The study was carried out in Belgium and New Zealand and included 327 healthy male adults aged 18 to 55 years. The study started in January 2014 and was completed in June 2015.

The results of the study were presented at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting held in Orlando, USA on 25–29 October 2015.

The primary evaluation of the drugs was based on the area under the concentration time curve from time zero to infinity (AUC0-∞), the AUC time zero to last measurable concentration (AUC0-tz) and the maximum concentration, all measured up to Day 71.

This is Boehringer Ingelheim’s second pharmacokinetic study for its candidate adalimumab biosimilar (BI 695501). The company also completed a phase I safety and pharmacokinetics trial (NCT01505491) in July 2012 [1]. According to ClinicalTrials.gov the company is also currently carrying out a phase III trial in patients with active rheumatoid arthritis (NCT02137226), which is expected to be completed in December 2016.

Germany-based Boehringer Ingelheim created a dedicated division for the development and commercialization of biosimilars back in September 2011 [2]. However, it recently halted clinical development for its rituximab biosimilar (BI 695500) [3].

Editor's comment
It should be noted that data of the study presented in this article were published as a poster and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal. 

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Phase III results of adalimumab biosimilar demonstrate equivalence

Clinical trials for adalimumab biosimilars

1.   GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim completes biosimilar adalimumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 6]. Available from: www.gabionline.net/Biosimilars/Research/Boehringer-Ingelheim-completes-biosimilar-adalimumab-trial
2.   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 2015 Nov 6]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-joins-other-Big-Pharma-going-into-biosimilars
3.   GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim stops biosimilar rituximab development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 6]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-stops-biosimilar-rituximab-development

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Source: Boehringer Ingelheim, Clinicaltrials.gov

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