About Biosimilars

Biosimilars: An exciting new class of drugs
Overview
Benefits
Assessment
FAQ

The Opportunity to Improve Access to Therapies While Generating Significant Healthcare Savings

Biosimilars are new versions of existing biopharmaceuticals made in cellular biologic systems and are approved on the basis that they are highly similar to the reference product in terms of quality, safety, and efficacy. The term "biosimilars" is used to describe biologics developed to be highly similar to existing, branded biologics.1

Image of three chemist using a computer.

Biosimilars are not called generics because biologic drugs cannot be exactly copied. Biologics are derived from living cells or organisms and consist of relatively large and often highly complex molecular entities that may be difficult to fully characterize.2,3,4,5

Rigorously Reviewed by the FDA to Ensure Safety and Efficacy

Biosimilars follow an established development path to demonstrate and confirm that there are no clinically meaningful differences from their reference products:


Checkmark
Tested
for safety, purity, and potency
Checkmark
Confirmed
via analytical characterization and nonclinical and clinical trials
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Monitored
following market introduction


Biosimilar Affordability

$250 billion in healthcare savings may be realized by 2024 in the U.S. if 11 biologics that are the most likely candidates for biosimilars enter the market.6,7

Biosimilar Affordability graph

Discover the benefits of biosimilars. Learn more: Biosimilar FAQs.


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  1. United States Food and Drug Administration. Information for Healthcare Professionals (Biosimilars). http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241719.htm. Accessed January 26, 2017.
  2. Geigert J. The Challenge of CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics; 2013.
  3. Morrow T et al. Biotechnol Healthc. 2004;1:24-26,28-29.
  4. Haag et. al. The emergence of biosimilars: how are they different from generics and what are the implications from marketing? Presented at: European Pharmaceutical Market Research Association Meeting; June 29, 2011.
  5. Schellekens H. Biosimilar therapeutics- what do we need to consider? NDT Plus. 2009; 2(suppl 1)i27-136.
  6. Zelenetz AD, Ahmed I, Braud EL, et al. NCCN biosimilars white paper: regulatory, scientific, and patient safety perspectives. J Natl Compr Canc Netw. 2011;9(suppl 4):S1-S22.
  7. Miller S. The $250 billion potential of biosimilars. Express Scripts website. http://lab.express-scripts.com/lab/insights/industry-updates/the-$250-billion-potential-of-biosimilars. Published April 23, 2013. Accessed July 26, 2016.