China-based Bio-Thera Solutions (Bio-Thera) have begun a phase III clinical trial for BAT2506, copy biological of the anti-inflammatory molecule Simponi (golimumab).
Golimumab is a monoclonal antibody that targets the inflammatory molecule tumour necrosis factor-alpha (TNF-alpha). It can be used in the treatment of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis and is sold under the brand name Simponi by originator company Janssen.
BAT2506 is a proposed biosimilar to Janssen’s Simponi (golimumab), which is currently approved as a treatment for adults with moderate to severe rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis (PsA) .
In June 2021, China’s Bio-Thera announced the start of a phase III clinical trial for its copy biological of Simponi, currently known as BAT2506. The randomized, double-blind study will compare the efficacy of BAT2506 to originator golimumab in an estimated 480 people with psoriatic arthritis.
Shengfeng Li, CEO of Bio-Thera, said, ‘Patient enrolment in our Phase III clinical trial for BAT2506 is another important achievement for Bio-Thera as it is our third proposed biosimilar to enter a global Phase 3 study’.
Bio-Thera is developing biosimilars for tocilizumab , which is also used to treat inflammatory conditions, and bevacizumab , which is used to treat various forms of cancer. Both have completed phase III trials.
The BAT2506 trial will be performed in China and Europe and is expected to complete in October 2023. Simponi’s patents expire in the US and the EU in 2024.
BAT2506 is the first subcutaneous golimumab copy biological to enter phase III trials in a number of countries and, according to analysis from GlobalData, could be the first golimumab copy biological to be approved in China and Europe. Its only major competition comes from Reliance Life Sciences, which is conducting a phase III trial in India. ‘BAT2506 is the only golimumab biosimilar to initiate a Phase III trial in multiple countries and is expected to reap the maximum benefits of early entrant market penetration’, says Prashant Khadayate, Pharma Analyst at GlobalData.
On 18 July 2020, Bio-Thera has signed a licensing agreement for its proposed golimumab copy biological BAT2506 with Russian biopharmaceutical company Pharmapark, with exclusive rights to distribute and market BAT2506 with the status of a local product in Russia as well as other Commonwealth of Independent States (CIS) countries .
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1. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera partners with Pharmapark to market golimumab biosimilar in Russia and other CIS countries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/pharma-news/Bio-Thera-partners-with-Pharmapark-to-market-golimumab-biosimilar-in-Russia-and-other-CIS-countries
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for tocilizumab biosimilar BAT1806 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/biosimilars/research/positive-phase-iii-results-for-tocilizumab-biosimilar-bat1806
3. GaBI Online - Generics and Biosimilars Initiative. Positive results for Bio-Thera’s bevacizumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 30]. Available from: www.gabionline.net/biosimilars/research/Positive-results-for-Bio-Thera-s-bevacizumab-copy-biological
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