Germany-based biologicals specialist Boehringer Ingelheim (Boehringer) announced on 26 October 2016 positive results from its pivotal phase III study of its candidate adalimumab biosimilar.
The phase III trial evaluated the efficacy, safety and immunogenicity of Boehringer’s candidate adalimumab biosimilar BI 695501 versus AbbVie’s Humira (adalimumab) in patients with active rheumatoid arthritis.
The results, according to Boehringer, ‘met the clinical study primary efficacy endpoint to establish equivalence with Humira in patients with active rheumatoid arthritis’. The secondary endpoints for efficacy, safety and immunogenicity were also met, according to the company.
The randomized, double-blind, parallel arm, multiple dose, active comparator phase III study was started in January 2015 and planned to enrol 645 adults with a diagnosis of moderately to severely active rheumatoid arthritis for at least 6 months and who were receiving methotrexate treatment. It was carried out at 150 centres in Bulgaria, Chile, Estonia, Germany, Hungary, Korea, Malaysia, New Zealand, Poland, Russia, Serbia, Spain, Thailand, Ukraine and the US.
Participants were randomized to receive either BI 695501 or Humira every two weeks for 48 weeks. The primary objective of the study was to establish statistical equivalence in efficacy between BI 695501 and Humira in patients with active rheumatoid arthritis as measured by the proportion of patients meeting ACR20 (20% or greater improvement in American College of Rheumatology assessment) criteria at Week 12 and at Week 24 compared to baseline.
Secondary objectives included change from baseline in DAS28 (ESR) at Week 12 and Week 24 and the proportion of patients with drug-related adverse events (AEs) during the treatment phase.
Rival biosimilars maker Amgen gained approval from the US Food and Drug Administration (FDA) for its biosimilar adalimumab in September 2016 [1]. While Amgen and Samsung Bioepis (a Biogen and Samsung joint venture) have both submitted their marketing applications to the European Medicines Agency (EMA) for approval [2, 3].
Boehringer created a dedicated division for the development and commercialization of biosimilars back in 2011 [4]. The company has an insulin glargine biosimilar already on the market [5] and is also working on a biosimilar of bevacizumab [6]. Boehringer is also carrying out a long-term assessment of safety, efficacy, pharmacokinetics and immunogenicity of BI 695501 in patients with rheumatoid arthritis for patients who completed the original trial.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar adalimumab application submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-adalimumab-application-submitted-to-EMA
3. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis adalimumab biosimilar submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-adalimumab-biosimilar-submitted-to-EMA
4. 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 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-joins-other-Big-Pharma-going-into-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of insulin glargine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-insulin-glargine
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
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Source: Boehringer, ClinicalTrials.com
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