Germany-based biologicals specialist Boehringer Ingelheim (Boehringer) announced on 14 June 2017 positive results from its pivotal phase III study of its candidate adalimumab biosimilar.
The phase III VOLTAIRE-RA 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.
Boehringer said that the results from the randomized, double-blind, parallel arm, multiple dose, active comparator phase III study ‘confirmed that its adalimumab biosimilar candidate BI 695501 and Humira have similar efficacy, safety and immunogenicity in patients with moderately-to-severely active rheumatoid arthritis’.
The VOLTAIRE-RA trial was started in January 2015 and enrolled 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 co-primary objectives of the study were 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. These objectives were met, according to Boehringer. The 24-week results were presented at the Annual European Congress of Rheumatology (EULAR 2017), which took place on 14−17 June 2017 in Madrid, Spain.
Boehringer also announced data from the VOLTAIRE-AI study at EULAR 2017, which it says ‘demonstrated pharmacokinetic similarity of BI 695501’s pre-filled syringe and auto-injector presentations’.
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 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 and intends to present one year results ‘at a future medical congress’.
Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.
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Reference
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 Jun 23]. 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 Jun 23]. 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 Jun 23]. 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 Jun 23]. 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 Jun 23]. 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 Jun 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
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Source: Boehringer Ingelheim, EULAR
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