On 24 March 2026, Singapore-headquartered Prestige Biopharma announced that it is “accelerating commercialisation” of Vasforda®/HD204, biosimilar to Genentech’s Avastin® (bevacizumab), following positive results from its global Phase 3 clinical trial. The trial was conducted in patients with advanced non-squamous non-small cell lung cancer (NSCLC) and reportedly demonstrated clinical equivalence between Vasforda®/HD204 and Avastin®.
Under an agreement announced in July 2022, Prestige granted exclusive commercialisation rights for HD204 to Intas & Accord Healthcare for the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan. According to Prestige, in collaboration with Accord Healthcare, it has been preparing regulatory submissions for US and European markets, with marketing authorisation applications for HD204 expected to be submitted in H2 2026.
The first bevacizumab biosimilar approved in the US was Amgen’s Mvasi® in September 2017, with Mvasi® also being approved in Europe in January 2018. 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). More recently, on 13 January 2026, Shanghai Henlius Biotech announced that a Biologics Licence Application (BLA) for its bevacizumab biosimilar, HLX04, was accepted for review by the FDA.