Can Chinese biopharma finally break the innovation ceiling in autoimmune disease? Inside the IBI3011 playbook

Can Chinese biopharma finally break the innovation ceiling in autoimmune disease? Inside the IBI3011 playbook

For decades, China’s biopharma sector was best known for its rapid scaling of biosimilars, generics, and “fast follower” biologics. Industry watchers, both inside and outside the country, regarded Chinese firms as volume leaders but not science front-runners. This is now changing. The first-in-human dosing of IBI3011, Innovent Biologics’ anti-IL-1RAP monoclonal antibody, marks a turning point […]

Can Gotenfia finally unlock biosimilar competition for Simponi in Europe?

Can Gotenfia finally unlock biosimilar competition for Simponi in Europe?

STADA Arzneimittel AG and Bio-Thera Solutions have secured a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Gotenfia, a proposed biosimilar to the tumor necrosis factor alpha inhibitor golimumab. The product references Simponi, an originator drug widely prescribed for multiple autoimmune conditions. If approved, Gotenfia would be marketed […]