Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
Samsung Bioepis plans to start a global Phase 1 trial of SBE303, its first independently developed new drug candidate targeting Nectin-4. Preclinical data showed tolerability up to 40 mg/kg in monkeys.
Dr. Reddy's said the FDA accepted for review its 351(k) BLA for DRL_AB, a proposed interchangeable biosimilar to ORENCIA. The application covers an IV formulation for RA, PsA and pJIA.
Bio-Thera Solutions expands its partnership with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, through an exclusive commercialization agreement for India. The India biosimilars market is projected to grow from $184 million to $1.02 billion by 2035, driven by patent expirations and strategic partnerships.
The global antibodies market is projected to reach $667.8 billion by 2032 with a 12.9% CAGR, while high throughput antibody production services are expected to grow at 11.2% CAGR through 2033, driven by biopharmaceutical development and monoclonal antibody therapeutics demand.
The European Commission has granted marketing authorization for Gotenfia, a golimumab biosimilar to Simponi, developed by Bio-Thera and to be commercialized by STADA across the EU, EEA, UK, Switzerland and selected other countries.
