Understanding Biosimilars
UNDERSTANDING BIOLOGICS Knowing the Basics
UNDERSTANDING BIOLOGICS Knowing the Basics

The words “biologics” and "biosimilars" are being used more and more often, but what are they? Are they the same type of medicine? This section will help explain what biologic medicines are. It will also explain how they are different from other prescription medicines.

WHAT ARE BIOLOGIC MEDICINES?

Biologic medicines are made from living organisms. These can include human cells, animal cells, and microorganisms such as bacteria or yeast. Biologic medicines can be used to treat conditions such as rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions such as psoriasis, and various forms of cancer.1

HOW ARE BIOLOGIC MEDICINES DIFFERENT FROM OTHER PRESCRIPTION MEDICINES?

The more patients know about their medicines, the more in charge of their health they can be. The key points to remember are:

  • Biologic medicines are made from living organisms1
    • Many of them are used to treat serious and life-threatening conditions such as rheumatoid arthritis and cancers1
  • Biologic medicines are different from many prescription medicines because they are larger and more complex1,2,4,5
    • The size and complexity of biologics means copies can never be identical
References:
1. US FDA. Information for consumers (Biosimilars). http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241718.htm. Accessed June 24, 2016. 2. Shutterstock images. 3. Synagis (palivizumab). Prescribing information. AstraZeneca. 2016. 4. Berkowitz SA, Engen JR, Mazzeo JR, et al. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov. 2012;11:527–540. 5. Siegel J. Biosimilars in rheumatology. In: Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH, eds. Rheumatology. 6th ed. Philadelphia, PA: Elsevier Mosby; 2015:522–529. 6. National Center for Biotechnology Information. Aspirin. https://pubchem.ncbi.nlm.nih.gov/compound/aspirin#section=2D-Structure. Accessed June 3, 2016. 7. Genazzani AA, Biggio G, Caputi AP, et al. Biosimilar drugs: concerns and opportunities. Biodrugs. 2007;21:351–356. 8. Kuhlman M, Covic A. The protein science of biosimliars. Nephrol Dial Transplant. 2006;21[suppl5]:v4–v8.