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Biosimilars Portal: Regulation

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How the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the World Health Organization (WHO) regulate biosimilars

  • World Health Organization launches pilot procedure for prequalification of biotherapeutic products and similar biotherapeutic products - In February 2020, the WHO launched a pilot procedure for prequalification of two biotherapeutic products: rituximab and trastuzumab, to explore options to facilitate access to safe, effective and quality-assured biotherapeutic products and similar biotherapeutic products.
  • World Health Organization new Q&A on biosimilars  – in March 2019, the WHO launched a new Q&A to supplement the existing guidelines for the regulatory evaluation of biosimilar products to increase access to quality treatment.
  • European Commission/European Medicines Agency Information guide for healthcare professionals: Biosimilars in the EU - provides reference information on the science and regulation underpinning the use of biosimilar medicines (produced with input from clinical experts including ESMO)
  • European Medicines Agency page on biosimilar medicines – gives an overview of biosimilars and the work of EMA in this area
  • European Medicines Agency guidelines on biosimilars - EMA has established an extensive set of guidelines that aim to guide the course of action and support the increasing number of biosimilar applications
  • US Food and Drug Administration page on biosimilars – the page summarizes all the information put forward by the FDA to support marketing authorization applications and help stakeholders understand how biosimilars are developed and approved
  • World Health Organization guidelines on biosimilars – the page presents the guidelines of the WHO as well as related information (e.g. Q&A document) meant to increase regulatory convergence across the world 
  • World Health Organization kick-starts pilot prequalification of biotherapeutics for cancer treatment - in July 2018, the WHO launched a pilot prequalification of biotherapeutics for cancer treatment to improve the availability and affordability of expensive cancer treatments

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