IAPO Americas

Quick Guide on Biological and Biosimilar Medicines


This Quick Guide provides the reader with an introduction to biological and biosimilar medicines, why they are important, how biosimilars are different from the original biological medicine (known as the reference product) and also different from generic medicines, and what patients need to know to use them safely and effectively. It forms part of a wider Information and Advocacy Toolkit on Biological and Biosimilar Medicines for patients’ organizations which contains a Briefing Paper with more detailed information regarding these medicines, fact sheets, information on what patients’ organizations can do and links to a number of other resources.

Answering important questions

The quick guide answers important questions such as:

  • What are biological and biosimilar medicines?
  • Why are biological and biosimilar medicines important?
  • What should patients be aware of when taking biological medicines?
  • How do differences between biological and chemical medicines affect patients?
  • How are biosimilar medicines different from the reference biological medicine?
  • How are medicines approved?
  • What do patients need to know about the safety of biological medicines?
  • What information should patients report in case of an adverse event?
  • What issues should patients be aware of regarding which biological medicine they have been prescribed and received?
  • Can patients be sure that regulatory guidelines around the world will guarantee the quality, safety and efficacy of biological medicines?
  • Who can access biological medicines?
  • What information and support do patients need?


Download the full Quick Guide