China’s Bio-Thera Solutions announced in November 2022 that dosing has begun in a phase III clinical study for BAT2306, a proposed copy biological of arthritis anti-inflammatory treatment, Cosentyx (secukinumab). In addition, the company also recently announced a phase I clinical study to compare the pharmacokinetics and safety of BAT2606, a proposed copy biological of asthma treatment, Nucala (mepolizumab), to US-sourced and EU-sourced reference product in normal healthy volunteers.
Secukinumab is a human IgG1κ monoclonal antibody that binds to the protein interleukin (IL)-17A. In the US, secukinumab is prescribed for the following indications: 1) people 6 years of age and older with moderate to severe plaque psoriasis; 2) people 4 years of age and older with active enthesitis-related arthritis; 3) people 2 years of age and older with active psoriatic arthritis; 4) adults with active ankylosing spondylitis; and 5) adults with active non-radiographic axial spondyloarthritis and objective signs of inflammation. The reference product, Cosentyx (secukinumab) is available from Novartis. Bio-Thera’s phase III study is a randomized, double-blind, parallel group, active control study to compare the efficacy and safety of their copy biological product with Cosentyx in patients with moderate to severe plaque psoriasis. Following successful completion of the trial Bio-Thera hopes to submit approval applications to regulatory authorities around the world.
Mepolizumab is an interleukin-5 (IL-5) antagonist monoclonal antibody administered subcutaneously via syringe or autoinjector. Mepolizumab is indicated as an add-on maintenance treatment for adult and paediatric patients (aged 6 years and older) with severe asthma and with an eosinophilic phenotype, and for adult patients with chronic rhinosinusitis with nasal. It is also indicated for treatment of adult patients with eosinophilic granulomatosis with polyangiitis, and adult and paediatric patients (aged 12 years and older) with hypereosinophilic syndrome for ≥ 6 months without an identifiable non-haematologic secondary cause. The reference product Nucala (mepolizumab) is available from GSK. Following the successful completion of the phase I study, a phase III study will be initiated; and Bio-Thera will submit approval applications to regulatory authorities around the world.
Bio-Thera is developing several additional biosimilar (copy biological) products for the global market. These include, but are not limited to a bevacizumab biosimilar, BAT1706, application accepted in Europe and the US [1, 2]; a tocilizumab biosimilar, BAT1806, application accepted in China [3]; and clinical trials begin for golimumab and ustekinumab biosimilars [4, 5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 13]. Available from:
www.gabionline.net/biosimilars/news/FDA-accepts-application-for-bevacizumab-biosimilar-BAT1706
2. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 13]. Available from: www.gabionline.net/biosimilars/news/EMA-accepts-application-for-bevacizumab-biosimilar-BAT1706
3. GaBI Online - Generics and Biosimilars Initiative. China accepts Bio-Thera’s application for tocilizumab copy biological BAT1806 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 13]. Available from:
www.gabionline.net/biosimilars/news/china-accepts-bio-thera-s-application-for-tocilizumab-copy-biological-bat1806
4. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for Bio-Thera’s golimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 13]. Available from:
www.gabionline.net/biosimilars/research/clinical-trials-begin-for-bio-thera-s-golimumab-copy-biological
5. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera and Samsung Bioepis start clinical trials for ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 13]. Available from:
www.gabionline.net/biosimilars/news/bio-thera-and-samsung-bioepis-start-clinical-trials-for-ustekinumab-biosimilars
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