Bio-Thera Solutions, a biopharmaceutical company based in Guangzhou, China, has initiated the first Phase 3 study of a golimumab biosimilar in China and Eastern Europe, which is expected to enrol 598 subjects and achieve completion by October 2023. As the first golimumab biosimilar to gain approval in multiple countries, BAT2506 gives Bio-Thera Solutions early market penetration benefits. Bio-Thera has also partnered with Biogen to develop, manufacture and commercialise BAT1806, a tocilizumab biosimilar.
GlobalData reports that Guangzhou-based Bio-Thera Solutions has initiated a Phase 3 trial of BAT2506, a subcutaneous golimumab biosimilar, in China and Eastern Europe, making it the first to gain approval in these countries. Golimumab biosimilars are currently being investigated only by Bio-Thera and Reliance Life Sciences, the latter of which is conducting its Phase 3 study in India.
Market opportunity for golimumab biosimilars
“Janssen Biotech’s Simponi (golimumab) generated global sales of US$3.4 billion in 2020. Simponi is approved as a treatment for several autoimmune indications, including […] rheumatoid arthritis, active ankylosing spondylitis, […] psoriatic arthritis [and] ulcerative colitis.”
The sales potential for golimumab and its biosimilars presents a market opportunity for new biosimilar developers.
“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 entry market penetration,” stated Prashant Khadayate, pharma analyst at GlobalData.
The trial expects to enrol 598 subjects and achieve completion by October 2023.
Patent expiration, regulatory filings
Bio-Thera is expected to file for regulatory approvals in China and the EU by Q1 2024, and intends to do so with the US FDA as well, after Simponi’s patents in the US and EU expire.
According to analysts, Bio-Thera needs strong commercialisation partners to capitalise on its first to market advantage, and it has partnered with Pharmapark LLC to commercialise BAT2506 in Russia and other Commonwealth Independent States (CIS) countries.
Having launched the first Humira (adalimumab) biosimilar, Qletli, in China in January 2020, the golimumab biosimilar is the third most advanced within Bio-Thera’s immunology biosimilars portfolio.
Partnership with Biogen
Following a commercialisation and license agreement with Biogen, Bio-Thera published a Phase 3 study of BAT1806, a proposed biosimilar of Actemra/RoActemra (tocilizumab), demonstrating equivalent efficacy and safety in patients with moderate-to-severe rheumatoid arthritis. The study used the American College of Rheumatology 20% response criteria (ARC20) as the primary endpoint.
Under the agreement, Biogen gains exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries except China.
“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.