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FDA (2019). Considerations in Demonstrating Interchangeability with a Reference Product Guidance for Industry. https://www.fda.gov/regulatory-information

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• TITLE: Preparing for Volume-Based Procurement of Biologics: A Benchmarking Study of Biosimilar Policies in the EU and USA

  AUTHORS: Conghui Liu

  KEYWORDS: Biosimilars, Regulatory Systems, Policy Benchmarking, Biologics Industry Insight

  JOURNAL NAME: Open Journal of Social Sciences, Vol.11 No.9, September 28, 2023

  ABSTRACT: Driven by the centralized procurement of biologics in China, it is forcing an urgent evolution of the regulatory policy for biosimilars to break the zero-sum game at present. By benchmarking the relatively mature regulations of biosimilars in Europe and the United States, some decisive factors influencing the quality of biosimilar registration, review and approval are found. In order to ensure the safe and effective use of biologics and interchangeable products under the promotion of the centralized procurement process, and foster the development of biotechs and biopharmas, it is essential to reform the supervision of biologics, promote an entire competition in the market, and secure clinical medication for patients.