Bio-Thera golimumab biosimilar better positioned to get first to market advantage in China and Europe, says GlobalData

China’s Bio-Thera Solutions has recently initiated a Phase III trial of its proposed golimumab biosimilar BAT2506 in China and Eastern Europe. Against this backdrop, BAT2506 is the first subcutaneous golimumab biosimilar to enter a Phase III trial in multiple countries. It has the potential to be the first golimumab biosimilar to gain approval in China and Europe following successful clinical trials, finds GlobalData, a leading data analytics and research company.

According to GlobalData’s ‘Pharmaceutical Intelligence Center’ (as of 22 June 2021), only two companies – Bio-Thera Solutions and Reliance Life Sciences – are investigating golimumab biosimilars in Phase III trials. Reliance Life Sciences is conducting a Phase III trial in India.

Prashant Khadayate, Pharma Analyst at GlobalData, comments: “Janssen Biotech’s Simponi (golimumab) generated global sales of US$3.4bn in 2020. Simponi is approved as a treatment for several autoimmune indications, including adults with moderate to severe rheumatoid arthritis, active ankylosing spondylitis and psoriatic arthritis (PsA), as well as moderate to severe ulcerative colitis (UC).”

“The overall sales potential for biologic golimumab and the small existing golimumab biosimilars late-stage pipeline can attract new biosimilar developers to target golimumab biosimilars. 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.”

Golimumab biosimilar is the third most advanced biosimilar within the immunology biosimilars portfolio of Bio-Thera Solutions. Earlier, it launched the first Humira (adalimumab) biosimilar Qletli in China in January 2020 and published positive Phase III results of tocilizumab biosimilar recently.

BAT2506’s Phase III trial (EudraCT Number: 2020-002004-39) in PsA is expected to enroll 598 subjects. The trial will be executed in China and Eastern Europe and has a target completion date of October 2023. Accordingly, Bio-Thera Solutions is expected to file for regulatory approvals in China and the European Union by Q1 2024. Simponi’s patents are set to expire in 2024 in the US and EU.

Bio-Thera Solutions has not yet disclosed any plans related to the US trials. However, the company intends to file for regulatory approval with the US FDA.

Mr Khadayate concludes: “Although Bio-Thera Solutions can attain first to market advantage, it needs strong commercialization partners in multiple markets to gain a solid first mover advantage. It has already partnered with Pharmapark LLC to commercialize BAT2506 in Russia and other Commonwealth of Independent States countries.

“Considering the limited competition within the golimumab biosimilars space, it is expected that multiple companies will be interested in partnering with Bio-Thera Solutions. It is also possible that a big player can partner with Bio-Thera Solutions, such as that seen with its partnership with Biogen for Bio-Thera Solutions’ tocilizumab biosimilar worldwide commercialization rights (except for China), which was announced in April 2021, just two months before the publication of the biosimilar’s Phase III results in June 2021.”

More Media