Pfizer’s REFLECTIONS study will compare the pharmacokinetics of PF-06410293 and adalimumab sourced from the US and EU administered to healthy volunteers. The trial is a phase I, double-blind, randomized, parallel-group, single-dose, 3-arm study. The main objective of the study is to demonstrate equivalent pharmacokinetic properties – maximum observed serum concentration (C_max), area under the curve from time zero to last quantifiable concentration (AUC_t) and AUC from time zero extrapolated to infinity (AUC_¥) – of PF-06410293 and Humira (adalimumab) over a period of 43 days. The trial will include 210 healthy adults, aged 18–55 years, and is expected to be completed in January 2014.

Adalimumab is a human-derived, genetically engineered monoclonal antibody. The product acts to reduce excessive levels of human tumour necrosis factor (TNF) alpha, which plays an important role in abnormal inflammatory and immune responses. It therefore acts as an anti-TNF therapy, which is approved by EMA in the EU for the treatment of psoriasis, rheumatoid arthritis and Crohn’s disease.

Pfizer is also carrying out a phase II trial for its rituximab biosimilar (PF-05280586) in the US [1] and a phase I trial for its biosimilar infliximab candidate (PF-06438179) [2].

Germany-based biopharmaceutical specialist Boehringer Ingelheim Pharmaceuticals has also completed a phase I trial for a biosimilar version of adalimumab (BI 695501) [3]. While more recently South Korean BioCND Inc and China-based Genor Biopharma signed a deal on 21 May 2013 to co-develop monoclonal antibody biosimilars of both adalimumab and trastuzumab for South Korea and other emerging markets.

Abbott’s blockbuster Humira (adalimumab) had annual sales for 2012 of US$9.3 billion. The patents for the drug expire in the US in December 2016 and in Europe in April 2018 [4].

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Development of biosimilars for rheumatology [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 21]. Available from: www.gabionline.net/Biosimilars/Research/Development-of-biosimilars-for-rheumatology

2.  GaBI Online - Generics and Biosimilars Initiative. Trials to start for biosimilar infliximab and etanercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 21]. Available from: www.gabionline.net/Biosimilars/News/Trials-to-start-for-biosimilar-infliximab-and-etanercept

3.  GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim completes biosimilar adalimumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 21]. Available from: www.gabionline.net/Biosimilars/Research/Boehringer-Ingelheim-completes-biosimilar-adalimumab-trial

4.  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 2013 Jun 21]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

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