3SBio has filed a new drug application (NDA) with China's National Medical Products Administration (NMPA) for its bevacizumab biosimilar 601A in macular oedema secondary to branch retinal vein occlusion (BRVO), following a successful Phase III trial demonstrating non-inferiority to ranibizumab in best-corrected visual acuity (BCVA) improvement at 24 weeks. The recombinant humanised anti-VEGF monoclonal antibody (mAb) showed comparable efficacy in proportion of patients achieving five, ten and fifteen letter visual acuity gains at 12, 24 and 52 weeks with equivalent central retinal thickness reductions. Safety profile remained favourable with positive benefit-risk balance supporting potential approval as the first bevacizumab ophthalmic formulation in China.

Retinal vein occlusion (RVO) represents the second most common retinal vascular disease, with macular oedema occurring in 48% to 67% of cases causing significant vision impairment through fluid accumulation in the macula. Anti-VEGF therapy inhibits pathological angiogenesis and vascular permeability serving as standard care for vision preservation. 3SBio's 601A development addresses a need for cost-effective alternatives to existing VEGF inhibitors in ophthalmology while expanding treatment access in China for retinal diseases through domestic biomanufacturing capabilities.

PharmCube's NextBiopharm® database lists a total of 40 bevacizumab biosimilar programs active globally, the majority of which (31) hold market approvals. Click here to request a free trial for NextBiopharm®.