US-based biosimilars developer Coherus BioSciences (Coherus) announced on 23 June 2014 the start of a global phase III trial for a biosimilar version of etanercept.
The start of the phase III trial follows on from the announcement by Coherus in October 2013 that its etanercept biosimilar, CHS-0214, had met the primary endpoint of clinical pharmacokinetic similarity to the originator biological Enbrel (etanercept) in a confirmatory clinical study in healthy subjects [1].
The phase III trial aims to study the efficacy and safety of Coherus’s biosimilar (CHS-0214) compared to Amgen’s blockbuster arthritis treatment Enbrel (etanercept). The trial is a randomized, double-blind, parallel group, active control, multi-centre study with two groups of patients, one of which will receive the biosimilar and one of which will receive Enbrel. All patients will receive 50 mg of either CHS-0214 or Enbrel weekly for 24 weeks.
The trial will be carried out in two parts. In the first part the efficacy and safety of the biosimilar compared to Enbrel will be evaluated in subjects with rheumatoid arthritis who have had an inadequate response to treatment with methotrexate. The primary endpoint is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24.
In the second part (an open-label single arm study) patients with at least an ACR-20 response will receive CHS-0214 and continued response and safety will be evaluated.
The phase III study is expected to recruit 486 male and female subjects, diagnosed with rheumatoid arthritis for 6 months, aged 18 years and older. The study started in May 2014 and is expected to be completed in September 2015, according to ClinicalTrials.gov.
Enbrel had worldwide sales of US$8.8 billion in 2013, making it one of the top selling biologicals and a lucrative target for biosimilars developers. The patents on Enbrel are set to expire in Europe in February 2015, but will only expire in the US in November 2028 after Amgen was granted a new patent [2, 3].
Coherus is also planning another phase III trial with its biosimilar etanercept candidate (CHS-0214) in patients with chronic plaque psoriasis, according to ClinicalTrials.gov.
Coherus made an agreement with Daiichi Sankyo in May 2012 to develop and commercialize biosimilars of etanercept and rituximab in certain Asian countries including Japan [4]. Then in September 2013, Coherus made an exclusive collaboration agreement with Baxter International to develop and commercialize an etanercept biosimilar for Brazil, Canada, Europe and certain other markets [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Etanercept biosimilar has comparable pharmacokinetics to Enbrel [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/Research/Etanercept-biosimilar-has-comparable-pharmacokinetics-to-Enbrel
2. 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 Aug 14]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
3. GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028
4. GaBI Online - Generics and Biosimilars Initiative. Daiichi Sankyo and Coherus Biosciences make biosimilars deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Daiichi-Sankyo-and-Coherus-BioSciences-make-biosimilars-deal
5. GaBI Online - Generics and Biosimilars Initiative. Baxter and Coherus to collaborate on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/News/Baxter-and-Coherus-to-collaborate-on-biosimilars
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Source: ClinicalTrials.gov
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