Prestige posts positive Phase 3 data for Avastin biosimilar HD204
CURRENT BRIEF VERSION: Prestige Biopharma said its Phase 3 SAMSON-II trial met its primary endpoint for HD204, a proposed biosimilar to Avastin (bevacizumab), in adults with advanced non-squamous non-small cell lung cancer. In the randomized, double-blind study, 625 patients across 91 centers in 15 countries received either HD204 or Avastin plus standard chemotherapy, and the week-18 overall response rate was 48.7% with HD204 versus 46.5% with Avastin, meeting the prespecified criteria for clinical equivalence. The company said safety, pharmacokinetics, and immunogenicity were also comparable, positioning HD204 for potential regulatory filings. (prnewswire.com)
Why it matters: For veterinary professionals tracking the broader biologics market, this is another sign that biosimilar development remains active and commercially important across major therapeutic classes, including oncology. Recent human-market milestones outside bevacizumab underscore that momentum: Teva recently won FDA approval for Ponlimsi, a biosimilar to Prolia (denosumab), and also had its omalizumab biosimilar accepted for review by both the FDA and EMA, each supported by analytical and clinical packages showing comparable efficacy, safety, and immunogenicity to the reference products. Bevacizumab is already a crowded biosimilar class in human medicine: the FDA lists five approved Avastin biosimilars, including Mvasi, Zirabev, Alymsys, Vegzelma, and Avzivi. In the US, bevacizumab biosimilars had already reached about 90% market share by late 2024, and average sales price discounts in the category were about 49% in Q1 2025, underscoring how quickly competition can reshape treatment economics once another entrant arrives. (fda.gov)
What to watch: The next milestone is whether Prestige turns these topline data into regulatory submissions in the US and Europe, and how HD204 would compete in a bevacizumab market that already has deep biosimilar penetration. Broader biosimilar activity, including recent FDA approvals and filing acceptances in denosumab and omalizumab, suggests regulators and manufacturers are still pushing aggressively into established biologics categories. (prnewswire.com)