A phase III study of an etanercept biosimilar from Sandoz and a phase I study of a bevacizumab biosimilar from Boehringer Ingelheim have, according to the companies, shown the biosimilars to be ‘bioequivalent’ (bevacizumab) or have ‘equivalent’ safety and efficacy (etanercept) compared to their respective originator biologicals.
Boehringer Ingelheim announced on 16 November 2016 that new data from its phase I INVICTAN-1 study of its bevacizumab biosimilar, BI 695502, had ‘met all the pre-defined primary and secondary endpoints’. In addition, the results confirmed that BI 695502 was well-tolerated, with no clinically relevant differences in safety or immunogenicity evaluations between the BI 695502 and bevacizumab treatment groups. These data were presented in a poster at the American Association of Pharmaceutical Scientists Annual Meeting in Denver, USA on 13-17 November 2016.
The phase I, randomized, blinded, single-dose, parallel-arm, active comparator study enrolled 91 healthy males. Patients were randomized to receive either BI 695502 or Humira via a single intravenous infusion. The primary objective was to evaluate the bioequivalence (how a drug is absorbed, distributed, metabolized and excreted in the body) of BI 695502 to Avastin.
Boehringer Ingelheim says that the results ‘are an important step to confirm that BI 695502 is biosimilar to Avastin’. They also confirmed that they also have a phase III study (INVICTAN-2) underway to investigate the safety and efficacy of BI 695502 compared to Avastin in patients with advanced non-squamous non-small cell lung cancer.
Sandoz, which is the generics division of Novartis, announced on 18 November 2016 the publication of the results of its EGALITY study in the British Journal of Dermatology. The confirmatory clinical safety and efficacy study shows, according to Sandoz, that its etanercept biosimilar (GP2015) ‘is equivalent to the originator biological, Enbrel (etanercept), in more than 500 adult patients over 52 weeks’ [1].
The results, according to Sandoz, showed ‘no clinically meaningful differences between biosimilar etanercept and the originator product in safety and efficacy over 52 weeks’ in patients with moderate to severe chronic plaque-type psoriasis. In addition, Sandoz adds that the ‘innovative study design demonstrates switching between biosimilar etanercept and the originator product has no impact on safety and efficacy’.
The etanercept biosimilar (GP2015) was approved by the US Food and Drug Administration (FDA) in all five indications of the originator product (Enbrel) in August 2016 [2]. The FDA has designated the placeholder non-proprietary name of etanercept-szzs for the product, which will be called Erelzi. GP2015 was also submitted to the European Medicines Agency (EMA) for approval in December 2015 [3].
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References
1. Griffiths C, et al. The EGALITY study: a confirmatory, randomised, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, versus the originator product in patients with moderate to severe chronic plaque-type psoriasis. Br J Dermatol. 2016 Oct 27. doi:10.1111/bjd.15152. [Epub ahead of print]
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar etanercept Erelzi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-etanercept-Erelzi
3. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Dec 9]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-etanercept-biosimilar
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Source: Boehringer Ingelheim, ClinicalTrials.gov, Sandoz
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