On 13 August 2025, Shanghai Henlius and Hong Kong-headquartered EssexBio announced that China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) has accepted for review their New Drug Application (NDA) for HLX04-0, an ophthalmic preparation product based on Henlius’ biosimilar to Roche/Genentech’s Avastin® (bevacizumab). HLX04-O is intended for the treatment of wet AMD.
The companies entered into a co-development and exclusive licensing agreement in October 2020, under which EssexBio was granted an exclusive licence to develop, manufacture and commercialise HLX04 (biosimilar bevacizumab) globally.
The first and only authorised ophthalmic formulation of bevacizumab in the EU and UK, Lytenava™ (bevacizumab gamma, ONS-5010), which received EU approval in May 2024 and UK approval in July 2024, was launched in the UK and Germany in June 2025 by Outlook Therapeutics. In the US, the product is still under regulatory consideration, with Outlook Therapeutics having resubmitted its BLA to the FDA in February 2025, after receiving a complete response letter in 2023.
Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD in March 2025.