Sandoz starts phase III biosimilar adalimumab trial

Biosimilars/News | Posted 10/01/2014 post-comment0 Post your comment

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 18 December 2013 the start of a phase III clinical trial for a biosimilar version of adalimumab in patients suffering from psoriasis.

Adalimumab 2 V14A10

The drug is a biosimilar version of AbbVie’s blockbuster arthritis and psoriasis treatment Humira (adalimumab). Humira is a tumour necrosis factor (TNF) inhibiting anti-inflammatory drug. It is approved to treat rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis, Crohn’s disease and ankylosing spondylitis.

According to ClinicalTrials.gov, the Sandoz study will evaluate the efficacy, safety and immunogenicity of the company’s biosimilar adalimumab (GP2017) versus AbbVie’s Humira in patients with moderate to severe chronic plaque-type psoriasis.

The trial is a multicentre, double-blind, randomized, active controlled, parallel-group study. The main objective of the study is to demonstrate equivalent efficacy of GP2017 and Humira (adalimumab) in patients with moderate to severe chronic plaque-type psoriasis with respect to Psoriasis Area and Severity Index (PASI) 75 response rate over an initial period of 17 weeks. The trial will include 448 patients, aged 18 years and above, from Bulgaria, France, Germany, Hungary, India, Poland, Romania, Russia, Slovakia, Spain and the US, and patients will be randomized to receive GP2017 or Humira (adalimumab) solution for subcutaneous injection with an initial dose of 80 mg subcutaneously in Week 0, followed by 40 mg subcutaneously every other week, starting at Week 1 and ending at Week 33.

Results from the trial, which is expected to be completed by June 2015, are expected to support regulatory submissions in both the US and EU. The patent on Humira expires in the US in December 2016 and in Europe in April 2018 [1].

This study is the eighth phase III trial Sandoz has initiated across six biosimilar molecules. Sandoz is also currently conducting phase II and III clinical trials for a biosimilar version of Roche’s leading monoclonal antibody Rituxan/MabThera (rituximab) [2], as well as phase III trials with biosimilar filgrastim (Amgen’s Neupogen) and biosimilar pegfilgrastim (Neulasta) [3].

Sandoz already markets biosimilar somatropin (Omnitrope), biosimilar epoetin alpha (Binocrit) and biosimilar filgrastim (Zarzio) in countries across Europe and elsewhere. Omnitrope, approved under the 505(b)(2) pathway of the Hatch-Waxman Act, is also marketed in the US.

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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 2014 Jan 10]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

2.  GaBI Online - Generics and Biosimilars Initiative. Sandoz announces biosimilar rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 10]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-announces-biosimilar-rituximab

3.  GaBI Online - Generics and Biosimilars Initiative. Sandoz starts phase III trials for biosimilar filgrastim and pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 10]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-starts-phase-III-trials-for-biosimilar-filgrastim-and-pegfilgrastim

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Source: ClinicalTrial.gov, Sandoz

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