Biosimilars Are Highly Similar to the Clinical Profile of Their Reference Biologic

When exploring treatment options for patients with chronic, debilitating neurological conditions, it is critical to feel confident in the quality and efficacy of the medicine. Biologics have been used to treat a variety of neurological conditions.1,2

Biosimilars are biologics. Biosimilars are approved by the Food and Drug Administration (FDA) based on evidence that they are highly similar to the original biologic, called the reference biologic.1

Biosimilar fundamentals

Biosimilars are large, complex molecules made from living organisms.
As the name implies, biosimilars are highly similar to their reference biologic and3,4:
  • Are made from the same living sources
  • Are administered in the same way
  • Have the same strength and dosage
  • Undergo a rigorous FDA approval process
  • Have a highly similar clinical profile with no clinically meaningful differences in safety, purity, and potency

Unlike generics, biosimilars follow a clinical development process that is tailored rather than abridged

Demonstrated safety and efficacy

FDA approval of a biosimilar is based on the totality of evidence showing that it is highly similar to the reference biologic in terms of1,3:
  • Structure and functionality
  • Anticipated benefits and safety profile
Demonstrated safety and efficacy

Biosimilars meet rigorous FDA quality standards for development

ClinicalDevelopmentPreclinicalDevelopmentClinicalTrialsPK/PDPreclinical StudiesBiological CharacterizationPhysiochemical Characterization

Tap for details

Phase III confirmatory safety and efficacy studies6
Phase I PK and PD studies4
Preclinical studies consisting of 2 types of animal studies7:
  • Animal PK/PD studies
  • Animal toxicity studies
State-of-the-art technology comparing key characteristics, such as purity, chemical identity, and bioactivity1

Generating savings and increasing access

The emergence of biosimilars is creating competition that is fueling reductions in healthcare spending and increasing access to potentially life-changing medicines.3

1.2M patients

An estimated 1.2 million patients could gain access to potentially life-changing medicines by 2025 as biosimilars become available for the 7 leading biologics.8


$183B saved

By 2025, it is projected that the US health system will save up to $183 billion through the availability of biosimilars.9

If you’re interested in learning more about biosimilars, you can access biosimilar education resources here.
Sandoz: Pioneers in biosimilar development

Sandoz: Pioneers in biosimilar development

Sandoz has a rich heritage in bringing quality biosimilars to market. Sandoz is a global leader in biosimilars and, in 2015, became the first manufacturer to bring them to patients in the United States.10
Photos used are not of actual patients or healthcare professionals.
*Additional clinical studies are conducted only when residual uncertainties remain about the demonstration of no clinically meaningful differences after conducting the comparative pharmacokinetic/pharmacodynamic studies and immunogenicity assessment. These studies are different from the role of Phase 3 efficacy and safety trials conducted to support traditional drug development.11
  1. U.S. Food & Drug Administration. Biological Product Definitions. https://www.fda.gov/media/108557/download. Accessed July 3, 2022.
  2. Timoshin N. FDA drug and biologic approvals for neurology: 2017 mid-year review. NeurologyLive Website. https://www.neurologylive.com/view/fda-drug-and-biologic-approvals-neurology-2017-midyear-review. Published August 11, 2017. Accessed July 3, 2022.
  3. U.S. Food & Drug Administration. Overview of Biosimilar Products. https://www.fda.gov/media/151058/download. Accessed July 3, 2022.
  4. U.S. Food & Drug Administration. Biosimilar Product Regulatory Review and Approval. https://www.fda.gov/media/108621/download. Accessed April 8, 2022.
  5. Grande E, Carrato A. Biosimilars: what they are and their use in oncology. Cancer Chemo Rev. 2011;6.
  6. Weise M, Bielsky MC, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012;120(26):5111‑5117
  7. Webborn P. The role of pharmacokinetic studies in drug discovery: where are we now, how did we get here and where are we going? Future Med Chem. 2014;6(11):1233‑1235.
  8. The Biosimilars Council. Biosimilars in the United States: Providing More Patients Greater Access to Lifesaving Medications. http://biosimilarscouncil.org/wp-content/uploads/2019/03/Biosimilars-Council-Patient-Access-Study.pdf. Published 2017. Accessed July 3, 2022
  9. The U.S. Generic & Biosimilar Medicines Savings Report. Association for Accessible Medicine. https://accessiblemeds.org/sites/default/files/2021-10/AAM-2021-USGeneric-Biosimilar-Medicines-SavingsReport-web.pdf. Published October 2021. Accessed July 12, 2022.
  10. FDA approves first biosimilar Zarxio (filgrastim-sndz). Sandoz Website. https://www.us.sandoz.com/news/media-releases/fda-approves-first-biosimilar-zarxiotm-filgrastimsndz. Accessed July 12, 2022.
  11. U.S. Food & Drug Administration. Biosimilar Development Process. https://www.fda.gov/files/drugs/published/Biosimilar-Development-Process.pdf. Accessed July 3, 2022.