A phase III study of an adalimumab biosimilar (CHS‑1420) from Coherus has reported that the biosimilar is ‘similar’ to AbbVie’s Humira (adalimumab), according to the company.
US-based biosimilars developer Coherus BioSciences (Coherus) claimed on 10 January 2017 that its ongoing 3-part phase III study demonstrated ‘similarity between CHS‑1420 and Humira with respect to the percentage of subjects achieving 75% improvement in Psoriasis Area and Severity Index (PASI-75) at week 12.
The 3-part, phase III, randomized, parallel-group, active-controlled, double-blind, multicentre, global study was designed to compare the efficacy and safety of CHS‑1420 versus Humira in subjects with chronic plaque psoriasis. The study planned to enrol a total of 545 psoriasis patients in a 1:1 ratio to receive either CHS‑1420 or Humira and includes 24 weeks of administration of blinded study drug followed by 23 weeks of administration of open-label CHS-1420 and a follow-up visit 8 weeks after the last dose.
Results from Part 2 of the study focused on maintenance of response through Week 24. At the start of Part 2 (Week 16), 80.3% of subjects in the CHS‑1420 group and 77.5% of subjects in the Humira group achieved PASI-75. In Part 2 (Weeks 16−24), half of the subjects who were initially treated with Humira were switched to CHS‑1420, modelling a chronic patient’s transition to a biosimilar. In Part 2, maintenance of PASI-75 was similar across the three subsequent treatment groups: CHS‑1420 followed by CHS‑1420, Humira followed by CHS‑1420, and Humira followed by Humira. CHS‑1420 and Humira were similarly well tolerated in all groups during Part 2. Preliminary anti-drug antibody results did not identify any clinically significant differences between the treatment groups.
The results, according to Coherus, demonstrated ‘similarity between CHS‑1420 and Humira’ and will be presented at a forthcoming scientific conference. Coherus expects to submit its biosimilar application in the US in the first half of 2017.
Coherus also has two other late-stage candidate biosimilars. The company submitted the application for its proposed pegfilgrastim biosimilar (CHS 1701) to the European Medicines Agency in November 2017 [1] and to the US Food and Drug Administration in October 2016 [2]. The company also claimed positive phase III results for its candidate etanercept biosimilar (CHS‑0214) in November 2015 [3]. Coherus says that it is ‘developing a robust pipeline of future products in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis’.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 10]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
2. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for pegfilgrastim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 10]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-pegfilgrastim-biosimilar-from-Coherus
3. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for etanercept biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 10]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-etanercept-biosimilar
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