Prestige Biopharma posts positive Phase 3 data for Avastin biosimilar

Prestige Biopharma has reported positive topline Phase 3 results for HD204, its proposed biosimilar to Avastin (bevacizumab), saying the SAMSON-II study met its primary endpoint in advanced non-squamous non-small cell lung cancer. The company announced that overall response rate at week 18 demonstrated clinical equivalence between HD204 and the reference product, Avastin, adding another late-stage candidate to the established bevacizumab biosimilar field. (prnewswire.com)

The readout follows a long development path for HD204. Prestige and Intas Pharmaceuticals announced a commercialization and supply partnership for the asset in 2022, with Accord Healthcare expected to handle commercialization in a wide range of territories, including the US and Europe. At that time, the companies said US and EU filings were planned after Phase 3 development, and Prestige had already reported positive Phase 1 pharmacokinetic, safety, and immunogenicity data from the earlier SAMSON-I program. (businesswire.com)

According to Prestige, SAMSON-II enrolled 625 patients at 91 centers in 15 countries and randomized them 1:1 to HD204 or Avastin plus standard chemotherapy. The company reported week-18 overall response rates of 48.7% for HD204 and 46.5% for Avastin. The risk ratio was 1.047, with a 95% confidence interval of 0.86 to 1.27, and the risk difference was 0.022, with a 95% confidence interval of negative 0.07 to 0.11, with both measures inside the predefined equivalence range. Prestige also said secondary endpoints supported the primary analysis, with similar progression-free survival and overall survival, and no statistically significant differences between groups. Treatment-related adverse events were reported in 33.9% of the HD204 arm and 34.4% of the Avastin arm, while treatment-related serious adverse events were 5.2% and 8.3%, respectively. No new safety signals were reported. (prnewswire.com)

The underlying study has been registered on ClinicalTrials.gov as a randomized, double-blind, parallel-group Phase 3 comparison of HD204 against EU-licensed Avastin in metastatic or recurrent non-squamous NSCLC, assessing efficacy, safety, pharmacokinetics, and immunogenicity. That registration helps confirm the study design and the role of NSCLC as a standard biosimilar-sensitive setting for a bevacizumab comparison. (clinicaltrials.gov)

Prestige framed the results as support for a development model that leans heavily on analytical characterization and comparative PK work, with CEO Lisa Park saying the program shows how biosimilarity can be established with increasing precision. Independent reaction specifically to SAMSON-II appears limited so far, but the broader market context is clear: bevacizumab biosimilars are already well established in the US, where the FDA’s biosimilar product list includes several Avastin biosimilars, including Jobevne, approved in April 2025. That backdrop also fits a wider biosimilars expansion story beyond oncology. Recent industry reporting highlighted FDA approval of Teva’s denosumab biosimilar Ponlimsi for all indications of Prolia, as well as FDA and EMA acceptance of Teva’s omalizumab biosimilar filings across all approved Xolair indications, both supported by analytical and clinical data packages showing similar efficacy, safety, and immunogenicity to the reference products. In other words, HD204 is moving forward in a market where regulators and manufacturers are continuing to normalize biosimilar development across multiple specialty categories, not just cancer. (prnewswire.com)

Why it matters: This isn’t veterinary therapeutics news in a direct sense, but it is relevant to veterinary professionals who follow comparative oncology and biologics market dynamics. Human oncology continues to be the proving ground for biosimilar adoption, and each additional entrant can increase competitive pressure on pricing, contracting, and formulary access. For veterinarians, that matters less because HD204 itself is aimed at human oncology, and more because human biologics markets often shape pet parent expectations around affordability, access, and the idea that complex biologics can eventually face competition. The added signal from denosumab and omalizumab biosimilar progress is that this is not an isolated bevacizumab story; it reflects a broader regulatory and commercial environment in which biosimilars are gaining traction across specialty medicine. It’s also another reminder that biologic development, manufacturing scale, and regulatory science are moving toward lower-clinical-burden biosimilar pathways, which could influence long-term thinking in animal health, even if veterinary biosimilar frameworks remain much less mature. This last point is an inference based on the trajectory of human biosimilar regulation and market adoption. (prnewswire.com)

What to watch: The next milestones are likely a full presentation or publication of the SAMSON-II dataset, formal regulatory submissions in the US and Europe, and more detail on launch sequencing through Prestige’s partnership with Intas and Accord. The biggest practical question isn’t whether there’s room for another bevacizumab biosimilar, but whether HD204 can win share in a market where multiple Avastin biosimilars are already approved and uptake is increasingly driven by contracting, reimbursement, and channel strategy rather than novelty alone. It’s also worth watching whether the broader biosimilars momentum seen in products like denosumab and omalizumab continues, because that will help define how favorable the regulatory and commercial climate remains for late-arriving entrants such as HD204. (prnewswire.com)