Taiwanese biosimilars developer Mycenax announced on 31 December 2018 that results from the phase I study of its tocilizumab biosimilar, LusiNEX, had met its primary endpoints.
The aims of the phase I trial, which was carried out in Australia, were to study the pharmacokinetics (PKs), pharmacodynamics (PDs), safety, tolerability and immunogenicity of Mycenax’s biosimilar, LusiNEX, compared to Roche’s Actemra/RoActemra (tocilizumab). The trial is a randomized, double-blind, 3-arm, parallel-group single-dose study in healthy subjects.
A total of 190 healthy volunteer subjects were randomized to one of three treatment arms and received a single intravenous dose (4 mg/kg) of EU-licensed Actemra, US-licensed Actemra or LusiNEX.
After dosing, subjects were observed for 8 weeks to evaluate the bioequivalence of LusiNEX in terms of PK, safety and tolerability compared to the originator product, Actemra. The study’s primary endpoint was the area under concentration-time curve from time 0 (pre-dose) extrapolated to infinity (AUC0 ∞). The study’s prespecified bioequivalence margin was 80-125%.
The results demonstrated that LusiNEX met its primary endpoint in PK comparison (AUC0 ∞). The geometric mean ratio was 96.60% (90% CI, 92.33%‒101.06%) and 95.58% (91.30%‒100.07%) compared with EU and US originators, respectively. According to Mycenax, other PK parameters and the types and incidence rates of adverse events observed in the LusiNEX group were also comparable to those seen in the two originator groups.
Karen Wen, President at Mycenax Biotech, said that the company is planning to apply for scientific advice from both the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in the first quarter of 2019 in order to finalize its multinational phase III study design. The company has the goal of being granted marketing authorization for both intravenous and subcutaneous dosage forms.
To date, there are no tocilizumab biosimilars approved either in Europe or the US. However, it is an attractive candidate for biosimilar developers, as the product is associated with better drug survival and better clinical outcomes than antitumour necrosis factor therapies.
Other companies reported to be working on toclizumab biosimilars or non-originator biologicals include China-based Bio-Thera Solutions [1] and Hisun Pharmaceuticals [2], and USA-based Epirus Biopharmaceuticals [3]. Probably the closest rival is Bio-Thera Solutions, which started a phase I study of its toclizumab product, BAT1806, in July 2018.
Mycenax hopes to eventually commercialize its toclizumab biosimilar in China, the EU and the US.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Adalimumab copy biologicals accepted for review in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 8]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-copy-biologicals-accepted-for-review-in-China
2. GaBI Online - Generics and Biosimilars Initiative. Physicochemical and biological characterization study of copy biological tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 8]. Available from: www.gabionline.net/Biosimilars/Research/Physicochemical-and-biological-characterization-study-of-copy-biological-tocilizumab
3. GaBI Online - Generics and Biosimilars Initiative. Epirus expands biosimilars pipeline with Bioceros acquisition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 8]. Available from: www.gabionline.net/Pharma-News/Epirus-expands-biosimilars-pipeline-with-Bioceros-acquisition
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Source: ClinicalTrials.gov, Mycenax
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