Quality of Biosimilars

Biosimilars offer efficacy, safety, and purity comparable to their reference products.
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Biosimilars are rigorously tested to ensure that they meet safety and efficacy requirements established by regulatory agencies including the US Food and Drug Administration (FDA).

Biosimilars follow an established development path. A range of comparative nonclinical and clinical evaluations are completed to ensure that there are no clinically meaningful differences from their reference products1,2:

Biosimilars follow an established development path.

Data requirements vary on a case-by-case basis; however, extensive manufacturing, non-clinical pharmacology, toxicology, pharmacokinetics, pharmacodynamics, and clinical data must be generated.

Like all pharmaceuticals, biosimilars continue to be monitored and assessed after market introduction.

Invention is not the only innovation.

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  1. 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. P S4, Table 3
  2. US Department of Health and Human Services. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Guidance for Industry. April 2015. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformaton/Guidances/UCM291128.pdf Section VI.