BAT2606

BAT2606 is a proposed biosimilar to mepolizumab, an interleukin‑5 (IL‑5) antagonist monoclonal antibody used as add‑on maintenance therapy in eosinophilic diseases such as severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome. BAT2606 demonstrated pharmacokinetic bioequivalence to US‑ and EU‑sourced mepolizumab (Nucala) following a single 100 mg subcutaneous dose in healthy men, with comparable safety and immunogenicity profiles and numerically lower anti‑drug antibody incidence versus the reference products. Bio‑Thera Solutions is developing BAT2606 and has conducted a randomized, double‑blind, parallel‑arm Phase 1 study (NCT05576454), with plans for a global Phase 3 to support extrapolation to all reference indications upon filing with major regulators. Mechanistically, as a mepolizumab biosimilar, BAT2606 binds IL‑5 to inhibit IL‑5 signaling, reducing eosinophil growth, activation, and survival.[1][3][2][5]

Other names

mepolizumab injection BAT2606