Biosimilars: The Future of Accessible, Safe, and Efficacious Medicines

Biologics are used to treat many neurological conditions.

According to a study involving >912,000 privately-insured patients with multiple sclerosis, peripheral neuropathy, epilepsy, dementia, or Parkinson’s disease,
out-of-pocket drug costs for these neurologic conditions increased sharply between 2004 and 2016.1 The most dramatic increase was attributed to multiple sclerosis medications, where average out-of-pocket drug costs rose 20x higher over 12 years.1

Biosimilars present a more economical option and are as safe and effective as their reference biologics.2

Developed under a rigorous FDA approval process

Biosimilars are medicines that are subject to a rigorous testing process and quality manufacturing standards required for Food and Drug Administration (FDA) approval.2

Compared to the reference biologic, biosimilars are highly similar in terms of2,3:
  • Active ingredients
  • Dosage
  • Post-marketing safety monitoring requirements
Learn how biosimilars are developed to ensure there are no clinically meaningful differences from the reference biologic.3

Biosimilars have no clinically meaningful differences from their reference biologic

Starting with physiochemical testing, biosimilars undergo a multistep review process. They are approved based on the totality of evidence that ensures they are highly similar to their the reference biologic in terms of safety, purity, and potency.4
Biosimilars have no clinically meaningful differences from their reference biologic
Biosimilars have no clinically meaningful differences from their reference biologic

Why choose a biosimilar over the reference biologic

The benefits of biosimilars go beyond healthcare cost savings. Biosimilars are increasing access to quality, cost-effective, and potentially life-changing medicines for millions of patients. An estimated 1.2 million patients could gain access to potentially life-changing medicines by 2025 as biosimilars become available.5

>$282M potential savings

In 2021, US patients could have saved more than $282 million in out-of-pocket costs had they used biosimilars instead of the reference biologics.6,*

45% less out-of-pocket

Patients who took certain biosimilars paid on average up to 45% less out-of-pocket than those who took the reference biologic.7
Why choose a biosimilar over the reference biologic

Biosimilar Education

Download these helpful resources to learn more about biosimilars

Biosimilars Flashcard

An educational resource detailing Sandoz heritage in biosimilar research and development


FDA – What is a Biosimilar? 

Useful information from the FDA explaining what a biosimilar is


FDA- Biosimilar Regulatory Review and Approval

A detailed explanation of the rigorous process required to obtain FDA approval of a biosimilar


FDA – Biosimilar Development Process

An overview of the development process for a biosimilar product

Sandoz: A global leader in biosimilars

Sandoz: A global leader in biosimilars

Sandoz is committed to bringing high-quality and affordable biosimilars to market so that more patients have access to potentially life-changing medicines.
Photos used are not of actual patients or healthcare professionals.
*Based on current prices of the 9 biologic drug classes with FDA-approved biosimilars.8
  1. Callaghan B, Reynolds E, Banerjee M, et al. Out-of-pocket costs are on the rise for commonly prescribed neurologic medications. Neurology. 2019:92;e2604‑e2613.
  2. U.S. Food & Drug Administration. Overview of Biosimilar Products. Accessed July 3, 2022.
  3. U.S. Food & Drug Administration. Biosimilar Regulatory Review and Approval.’s%20strategy%20to%20control%20the%20extent%20of,all%20medications%20after%20their%20approval. Accessed July 3, 2022.
  4. U.S. Food & Drug Administration. Biosimilar Product Regulatory Review and Approval. Accessed April 8, 2022.
  5. The Biosimilars Council. Biosimilars in the United States: Providing More Patients Greater Access to Lifesaving Medications. Published 2017. Accessed July 3, 2022.
  6. Biosimilars: billions in health care savings America needs. Biosimilars Forum Website. Accessed July 3, 2022.
  7. Socal M, Ballreich J, Chyr L, Anderson G. The ERISA Industry Committee. Biosimilar medications—savings opportunities for large employers. Published March 2020. Accessed July 3, 2022.