Assessing Biosimilarity
UNDERSTANDING BIOLOGICS Introducing Biologics & Biosimilars
UNDERSTANDING BIOLOGICS Introducing Biologics & Biosimilars

Biologics include a wide range of treatments such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. They can be used to treat a variety of medical conditions for which no other treatments are available.1

BIOLOGICS ARE COMPLEX, WITH DISTINCT DIFFERENCES COMPARED WITH SMALL MOLECULES

Unlike small molecules, which are usually chemically derived and have simple, well-defined structures, biologics are typically large, complex, and less easily characterized.1,2 Some biologics consist of simple peptides and many, such as monoclonal antibodies, are much larger and more complex.3

WHAT ARE BIOSIMILARS?

Biosimilars are biologics that are highly similar to originator (also known as “reference”) biologics, notwithstanding minor differences in clinically inactive components.9

  • There are no clinically meaningful differences between a biosimilar and an originator biologic in terms of safety, purity, and potency9
BIOSIMILARS ARE NOT GENERICS
BIOSIMILARS ARE DIFFERENT

In order to support that there are no clinically meaningful differences between an originator biologic and biosimilar, the FDA requires human PK and PD studies as well as clinical immunogenicity assessment.11

If residual uncertainty about biosimilarity remains, an additional comparative clinical study or studies may be needed.11

FDA, Food and Drug Administration; PD, pharmacodynamics; PK, pharmacokinetics.
References:
1. US FDA. What are “biologics” questions and answers. http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/ucm133077.htm. Accessed June 3, 2016. 2. 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. 3. 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. 4. Shutterstock images. 5. National Center for Biotechnology Information. Aspirin. https://pubchem.ncbi.nlm.nih.gov/compound/aspirin#section=2D-Structure. Accessed June 3, 2016. 6. Synagis (palivizumab). Prescribing Information. AstraZeneca. 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 biosimilars. Nephrol Dial Transplant. 2006;21[suppl5]:v4–v8. 9. 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 3, 2016. 10. US FDA. Generic drugs: questions and answers. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm. Accessed June 3, 2016. 11. 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.