This site is intended for U.S. health care professionals.
This site is intended for U.S. health care professionals.

Building Trust
with Biosimilars

Could biosimilars be a reliable option for your institution?

Biosimilars can be prescribed for patients with or without previous treatment history on an originator biologic.1 Learn how to make an impact by adopting with confidence.

Reference: 1. Prescribing biosimilar products. US Food and Drug Administration. Updated October 23, 2017. Accessed March 22, 2023.

What are the goals of biosimilar development?

Biologics are highly complex molecules synthesized from a living source.1 The complexity of these molecules requires a rigorous development and approval process for both originator biologics and biosimilars, with unique goals for each approval pathway.2,3

Goal of originator biologic

Demonstrate the efficacy and safety of a proposed product.3

Preclinical research

Clinical trial—Phase I

Clinical trial—Phase II

Clinical trial—Phase III

When a biologic is proposed for an established originator biologic2,3

Goal of biosimilar development:

Demonstrate no clinically meaningful differences in safety, purity, and potency from an approved reference biologic.2,3

Multifactorial analysis: structural and functional testing

Comparative human PK/PD and immunogenicity studies

Comparative clinical studies may be conducted

The FDA established this process to create an abbreviated approval pathway for biosimilars.4

Discover the building blocks of biosimilarity

FDA, US Food and Drug Administration; PD, pharmacodynamics; PK, pharmacokinetics.

References: 1. Biological product definitions. US Food and Drug Administration. Updated July 28, 2021. March 22, 2023. 2. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. US Food and Drug Administration. April 2015. Updated April 24, 2020. Accessed March 22, 2023. 3. Christi L. FDA's overview of the regulatory guidance for the development and approval of biosimilar products in the US. US Food and Drug Administration. Accessed March 22, 2023. 4. Biosimilars Action Plan. Balancing innovation and competition. US Food and Drug Administration. July 2018. Accessed March 22, 2023.