On 18 August 2026, Avalon Pharmaceutical and Bio-Thera Solutions announced that they have entered into an exclusive licensing agreement for the commercialisation of Bio-Thera’s BAT2406, biosimilar to Sanofi/Regeneron’s Dupixent® (dupilumab), in MENA.
Under the agreement, China-based Bio-Thera is responsible for the development, manufacturing and supply of BAT2406, while Saudi-based Avalon Pharma is responsible for seeking regulatory approvals and commercialisation. BAT2406 is currently in Phase I clinical trials.
Bio-Thera has also partnered with Costa-Rican-based SteinCares on BAT2406, entering an exclusive licence and commercialisation agreement in June 2025 for LATAM.
Biosimilar dupilumab is under development by multiple companies, including Samsung Bioepis (SB33 in pre-clinical development), Alvotech and Advanz (AVT19 in early development), Binnopharm and Mabwell (MOU announced December 2025 for Russia), Daewoong Pharmaceutical and Chime Biologics (agreement announced June 2026), and Formycon (FYB208 in early development).
In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection. In January 2026, Chong Kun Dang received approval from the EMA and UK MHRA for its phase 1 clinical trial protocol for CKD-706 (dupilumab).