US biotech company Oncobiologics announced on 12 February 2015 that ONS-3010, its adalimumab biosimilar candidate, met the primary endpoints in its first clinical study.
A three-arm single-dose pharmacokinetic study was performed in healthy volunteers to compare ONS-3010 to both US- and EU-sourced Humira (adalimumab) reference products and the two reference products to each other. All of the pharmacokinetic endpoints met the bioequivalence criteria of the geometric mean ratios within the 90% confidence interval of 80–125%. These included: maximum serum concentration (Cmax), area under the time-concentration curve from first time point extrapolated to infinity (AUC0-inf), and area under the time-concentration curve from first to last time point measured (AUC0-t).
The 80–125% rule states that two versions of a drug are generally said to be bioequivalent if the 90% confidence intervals for the ratios of the geometric means (brand-name versus generic) of the AUC and Cmax fall within 80% and 125%.
Safety and immunogenicity were similar across the three arms. An exploratory ex vivo pharmacodynamic study also showed encouraging results between ONS-3010 and the reference products on TNF-α blockade and the induction of specific inflammatory responses. This first-in-human study was conducted by the Centre for Human Drug Research (CHDR) in Leiden, The Netherlands.
AbbVie’s blockbuster arthritis and psoriasis treatment Humira (adalimumab), the world’s top selling prescription drug, earned the company more than US$12.5 billion in 2014, accounting for 63% of AbbVie’s total sales. Patents on Humira expire in the US in December 2016 and in Europe in April 2018 [1].
Oncobiologics is not the only company with adalimumab in development. At least 10 companies are reported to be working on biosimilars of adalimumab [2]. Both Amgen and Sandoz have also started phase III trials with their biosimilar adalimumab candidates [3, 4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
3. GaBI Online - Generics and Biosimilars Initiative. Amgen starts another phase III trial for biosimilar adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Biosimilars/News/Amgen-starts-another-phase-III-trial-for-biosimilar-adalimumab
4. GaBI Online - Generics and Biosimilars Initiative. Sandoz starts phase III biosimilar adalimumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 May 4]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-starts-phase-III-biosimilar-adalimumab-trial
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