Recently, Ms. Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, was invited to attend a biosimilars industry roundtable co-hosted by the U.S. Food and Drug Administration (FDA) and industry associations. The meeting brought together FDA officials, industry experts, and representatives from leading global biosimilar companies, including Sandoz, Samsung Bioepis, and Teva. During the discussion, Henlius provided an overview of the company and highlighted its achievements in the biosimilar field and engaged in in-depth exchanges with the FDA on topics including regulatory flexibility, R&D efficiency, and patient access to biosimilars.
Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius, noted: “We highly value dialogue with international regulators and industry peers, as it helps us better understand regulatory trends and contributes to the overall advancement of the sector. Looking ahead, Henlius will continue to actively participate in such international policy discussions and collaborations, accelerating the global accessibility of innovative and affordable therapies to benefit more patients worldwide.”
The United States is the world’s largest biologics market, yet high prices of originator products have long posed a significant burden on patients.1 Biosimilars have greatly improved treatment accessibility and affordability.2 In recent years, the FDA has advanced the modernization of approval pathways, including discussing the necessity of Phase 3 efficacy trials in biosimilar development and exploring the possibility of reducing or waiving certain traditional study requirements when analytical and clinical comparability is sufficient. These efforts aim to expedite approvals and bring benefits to patients sooner.
Henlius is committed to addressing unmet medical needs by working with global pharmaceutical companies and research institutions to accelerate the availability of its products and innovations worldwide. To date, six Henlius products have been approved overseas, reaching around 60 countries and regions across Asia, Europe, Latin America, North America, and Oceania. Among them, three biosimilars developed in-house—HERCESSI™ (trastuzumab), Bildyos® (denosumab-nxxp), and Bilprevda® (denosumab-nxxp)—have been approved by the FDA, while the Biologics License Application (BLA) for HLX11 (pertuzumab biosimilar) was accepted by the FDA in February 2025. In September, HLX17 (pembrolizumab biosimilar) received FDA approval to initiate a Phase 1 clinical trial.
Backed by its integrated global R&D, regulatory, and clinical development platform, as well as GMP-compliant manufacturing and quality systems, Henlius will continue to uphold a patient-centred approach. The company remains committed to deepening collaboration with international regulators and partners, bringing more quality, affordable biologics to patients worldwide and creating lasting value for global health.
【Reference】
1.Parasrampuria S, Murphy S. Comparing U.S. and International Market Size and Average Pricing for Prescription Drugs, 2017-2022: Issue Brief [Internet]. Washington (DC): Office of the Assistant Secretary for Planning and Evaluation (ASPE); 2024 Dec. Available from: https://www.ncbi.nlm.nih.gov/books/NBK611829/?utm_source=chatgpt.com
2.Association for Accessible Medicines (AAM). 2023 U.S. Generic & Biosimilar Medicines Savings Report. IQVIA, 2023. https://accessiblemeds.org/resources/reports/2023-savings-report-2
