Understanding Biologics Quality Is Critical
UNDERSTANDING BIOSIMILARS Knowing the Basics
UNDERSTANDING BIOSIMILARS Knowing the Basics

Both doctors and the press are starting to talk about "biosimilars." But what are they? This section will explain what biosimilars are and a little about how biosimilars work.

BIOSIMILARS: A NEW DEVELOPMENT

Biosimilars are a type of biologic medicine. They work in similar ways to an already approved biologic medicine. The biologic medicine that has already been approved by the Food and Drug Administration (FDA) is known as the originator biologic or reference product.1,2

BIOSIMILARS ARE NOT GENERICS
Generic drugs are copies of other prescription medicines
Generic drugs are made by using the same formula. Using the same formula creates a copy of the drug.3,4
Biosimilars are made by or from living cells
The living cells that are used to make biologics can cause tiny differences between batches of the medicine each time it is made. That means that the biologic medicine someone takes may not be exactly the same every time they take it. But biosimilars go through many tests to check that they act in a similar way in the body.2,5
BIOSIMILARS ARE TESTED IN CLINICAL TRIALS BEFORE THE FDA APPROVES THEM

Clinical trials prove that biosimilars are safe and effective. This clinical proof is shown to the FDA before they approve the biosimilar to be prescribed to patients.3-5

HOW BIOSIMILARS ARE SIMILAR TO ORIGINATORS

In the scientific and clinical trials the FDA requires, biosimilars prove they are similar to originators in these ways2,5:

If a doctor prescribes a biosimilar, it's important to know that patients are getting a medicine that is well tolerated and effective. The key points to remember are:

  • Biosimilars are not generics2-5
  • Biosimilars are biologic medicines that are similar to originator biologic medicines in structure, function, and clinical effect1,2
  • Biosimilars are approved by the FDA as safe and effective2,5
References:
1. US FDA. Biosimilar biological products. http://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM365448.pdf. Accessed June 24, 2016. 2. US FDA. Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf. Published April 2015. Accessed June 24, 2016. 3. US FDA. Generic drugs: questions and answers. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm. Accessed June 24, 2016. 4. 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. 5. US FDA. Scientific considerations in demonstrating biosimilarity to a reference product. http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Published April 2015. Accessed June 3, 2016.