Bio-Thera Moves Golimumab Candidate Into Phase 3 Trial

Guangzhou, China–based Bio-Thera Solutions has initiated a phase 3 clinical study for its golimumab biosimilar candidate (BAT2506) referencing Simponi.

The double-blind, randomized, parallel, control study will compare the efficacy and safety of BAT2506 with the reference product in patients with psoriatic arthritis (PsA). An estimated 480 patients will be enrolled.

In the United States, Simponi is indicated for PsA, with or without methotrexate, and in moderate to severe rheumatoid arthritis in combination with methotrexate for ankylosing spondylitis and moderate to severe ulcerative colitis.

“Bio-Thera is focused on developing and commercializing a pipeline of safe, effective, and affordable biosimilars and is proud to be a step closer to bringing a Simponi biosimilar to patients around the world,” said Shengfeng Li, CEO.

In January 2021, Bio-Thera had the biologics license application (BLA) for a bevacizumab biosimilar, BAT1706, accepted for review by the FDA, and regulators in China accepted the BLA for this drug candidate in June 2020.

The company is seeking to offer the bevacizumab product for use in all indications of Genentech’s reference agent (Avastin), including advanced, metastatic, or relapsed non–small cell lung cancer and metastatic colorectal cancer.

The company is also developing biosimilar forms of the tocilizumab and ustekinumab immunosuppressants, along with mepolizumab (asthma, inflammation) and dupilumab (allergies, including eczema and asthma) biosimilars.

In April 2021, Bio-Thera said it had signed an agreement with Biogen for the commercialization of the tocilizumab biosimilar (BAT1806). The drug is an anti–interleukin-6 receptor monoclonal antibody that references Actemra and would be targeted for treatment of moderate to severe rheumatoid arthritis in adults, juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome.

BAT1806 met safety and efficacy end points in a recent phase 3 study. Biogen would gain the manufacturing and commercial rights to BAT1806 in all countries outside the China area.