It has the potential to be the first golimumab biosimilar to gain approval in China and Europe following successful clinical trials, finds the data analytics and research company.
The Guangzhou, China headquartered Bio-Thera and another company, Reliance Life Sciences, are the only two firms investigating golimumab biosimilars in Phase 3 trials, say those researchers.
Reliance Life Sciences is conducting a Phase 3 study in India.
Market opportunity for golimumab biosimilars
“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,” commented Prashant Khadayate, pharma analyst at GlobalData.
BAT2506’s Phase III trial 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.
Patent expiration, regulatory filings
Simponi’s patents are set to expire in 2024 in the US and EU. Bio-Thera is expected to file for regulatory approvals in China and the EU by Q1 2024, says the data provider.
The Chinese company has not yet disclosed any plans related to the US trials. However, the company intends to file for regulatory approval with the US FDA, according to GlobalData’s report.
Although Bio-Thera can attain first to market advantage, it needs strong commercialization partners in multiple markets to reinforce that gain, say those analysts.
It has already partnered with Pharmapark LLC to commercialize BAT2506 in Russia and other Commonwealth of Independent States (CIS) 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,” added Khadayate.
The golimumab biosimilar is the third most advanced biosimilar within the immunology biosimilars portfolio of Bio-Thera. The company launched the first Humira (adalimumab) biosimilar Qletli in China in January 2020.
Partnership with Biogen
Earlier this month, it published a Phase 3 study of BAT1806, a proposed biosimilar referencing Actemra/RoActemra (tocilizumab), which indicated equivalent efficacy and a comparable safety profile in patients with moderate-to-severe rheumatoid arthritis.
And April this year saw the Chinese company enter into a commercialization and license agreement with Biogen to develop, manufacture and commercialize BAT1806.
Biogen gains exclusive regulatory, manufacturing, and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau, and Taiwan), allowing the Cambridge, Massachusetts company to expand its global biosimilars footprint.
With the Phase 3 study achieving satisfactory results, Biogen will make an upfront payment of US$30m to Bio-Thera.
The Biogen and Bio-Thera Phase 3 study used the American College of Rheumatology 20% response criteria (ARC20) as the primary endpoint, with the candidate demonstrating equivalence to the Actemra reference medicine in patients with moderate to severe rheumatoid arthritis inadequately controlled by methotrexate therapy.
“We are excited about these results and believe BAT1806 demonstrates equivalence in efficacy and pharmacokinetics as well as a comparable safety and immunogenicity profile to the reference product. Biosimilars have the potential to generate cost savings, healthcare sustainability and, if approved, BAT1806 would enable us to bring an additional therapeutic option to patients," said Ian Henshaw, head of global biosimilars at Biogen.