Biosimilars Education for Patients | Amgen

Biosimilars Education for Patients

Amgen is committed to developing high-quality biosimilar medicines for patients. Amgen was one of the first large-scale biotechnology manufacturers, and we have developed quality biologic medicines used in the treatment of millions of patients around the world. This page will help you understand what biosimilars are, their safety and effectiveness, and the value they provide.

What is a Biosimilar?

  • A biosimilar is a biologic medicine designed to work just like another FDA-approved biologic medicine, known as the reference medicine.1
  • Biologic medicines can be made of a mix of substances, even living things like cells and tissues.2
  • Biosimilar treatment options are available for chronic diseases, including rheumatoid arthritis, inflammatory bowel disease and psoriasis, as well as certain cancers.3

A biosimilar is a biologic medicine that is highly similar to, and has no clinically meaningful differences from, an FDA-approved biologic medicine, known as the reference biologic or reference medicine.4

The FDA undertakes a comprehensive approval process to determine whether a biosimilar is approved for medical use in the United States.5 This is because, like all biologics, biosimilars are developed in living cells and require a high level of scientific expertise to create. This complexity is why biosimilars are highly similar, but not identical, to their reference biologic.9

Are Biosimilars Safe and Effective?

  • Biosimilars have no clinically meaningful differences from the reference product. This means you can expect the same safety and effectiveness from the biosimilar over the course of treatment as you would the reference product.12
  • Biosimilars have the potential to increase treatment options and to help keep treatment costs down.5

To be approved, a biosimilar must show it has no clinically meaningful differences to the reference biologic in terms of quality, safety, and its ability to produce the desired outcome in patients (also known as efficacy)5,11


 
Biosimilar Manufacturing

At Amgen, our biosimilar medicines are manufactured with the same high degree of quality as any of our biologic medicines.8 Like all biologics, testing of biosimilars is performed during the manufacturing process to assess quality.


 
Regulatory Approval of a Biosimilar

All biosimilars must meet the robust regulatory standards of the appropriate local governmental agency, such as the FDA and the EMA, before they can be approved for use. A regulator may review information from analytical, nonclinical, and clinical studies (known as totality of evidence) to make sure a biosimilar works as well as its reference medicine. Once approved, all biosimilars, like all biologics, continue to undergo comprehensive monitoring to ensure patient safety and medicine effectiveness.7


 

The Value of Biosimilars

In addition to providing the same safety and effectiveness as their reference medicines, biosimilars have the potential to lower healthcare costs by driving market competition.5,6

Amgen's Heritage and Legacy

Amgen has been a biotechnology innovator since 1980. We have been steeped in this challenging field since the early days of recombinant DNA technology, when a handful of scientists and investors came together to prove the promise of innovative biotechnology.


We have developed more than two dozen approved treatments, including biosimilars, with more than 30 medicines in various stages of clinical development.


 

Amgen's medicines have reached millions of people in the fight against serious illnesses.


 

At Amgen, our mission has always been to serve patients.


 

Additional Information

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Advocacy Resources

 

References:

  1. Future Medicine. "Similar biotherapeutic products: overview and reflections." 2012. Available at: https://www.futuremedicine.com/doi/epub/10.2217/imt.12.128
  2. Center for Biologics Evaluation and Research. "What Are 'Biologics' Questions and Answers." U.S. Food and Drug Administration, FDA, https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/what-are-biologics- questions-and-answers.
  3. European Medicine Association (EMA). "What I Need to Know About Biosimilar Medicines." 2016. Available at: https:// ec.europa.eu/docsroom/documents/26643
  4. United States Food and Drug Administration. Biosimilar development, review, and approval. 2017. Available at: https:// www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval. Accessed January 1, 2024
  5. United States Food and Drug Administration. "Biosimilar and Interchangeable Biologics." 2021. Available at: https:// www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices
  6. IQVIA Institute. "Biosimilars in the United States 2020-2024 competition, savings, and sustainability." 2020. Available at: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/iqvia-institute-biosimilars-in-the-united-states.pdf. Accessed January 1, 2024.
  7. United States Food and Drug Administration. Scientific Considerations Demonstrating Biosimilarity to a Reference Product. 2015. Available at: https://www.fda.gov/media/82647/download. Accessed January 1, 2024.
  8. Vulto Jasquez. Rheumatology. 2017;56:iv14-iv29.
  9. Sekhon, et al. Biosimilars. 2011:1;1-11.
  10. United States Food and Drug Administration. "Biosimilars and Interchangeable Products." 2021. Available at: https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products. Accessed January 1, 2024.
  11. National Cancer Institute. NCI Dictionaries. 2021.  Accessed January 1, 2024.
  12. United States Food and Drug Administration. Biosimilar Basics for Patients. 2023. Available at: https://www.fda.gov/drugs/biosimilars/biosimilar-basics-patients. Accessed March 6, 2024.