On 13 January 2026, Shanghai Henlius Biotech announced that its Biologics Licence Application (BLA) for HLX04, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) has been accepted for review by the FDA.
HLX04 has previously been approved in China (2021) and in multiple Latin American countries, including Bolivia, the Dominican Republic, and Mexico. In October 2020, Henlius entered into a co-development and exclusive licensing agreement with Hong Kong-headquartered EssexBio, under which EssexBio was granted an exclusive licence to develop, manufacture and commercialise HLX04 globally.
The first bevacizumab biosimilar approved in the US was Amgen’s Mvasi® in September 2017. There are currently five other bevacizumab biosimilars included in the FDA’s approved drugs database: Pfizer’s Zirabev® (June 2019), Amneal’s Alymsys® (April 2022), Celltrion’s Vegzelma™ (September 2022), Bio-Thera/Sandoz’s Avzivi® (December 2023), and Biocon Biologics’ Jobevne™ (April 2025).
Henlius also has an ophthalmic preparation based on HLX04 under development, which is intended for the treatment of wet AMD. In August 2025, a new drug application for Henlius’ ophthalmic bevacizumab biosimilar, HLX04-O, was accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration.