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

Biosimilars development

Before a manufacturer applies for FDA approval of a proposed biosimilar, the product must go through a rigorous development and testing process.1 This is done via a stepwise approach:

Comparative Clinical Studies to Confirm Biosimilarity

Detailed analytical studies1

To identify and compare structural and functional characteristics and to demonstrate the “highly similar” characteristics of a biosimilar product to the reference biologic.

Detailed Analytical Studies to Demonstrate the 'Highly Similar' Characteristics of a Biosimilar Product to the Reference Biologic

Comparative clinical studies (if necessary)1

To confirm biosimilarity of the product in patients in at least 1 approved indication of the reference biologic.

Detailed Analytical Studies to Demonstrate the 'Highly Similar' Characteristics of a Biosimilar Product to the Reference Biologic

Comprehensive PK/PD studies1

To evaluate PK/PD in order to assess the similarities between the biosimilar and reference product profiles.

The FDA evaluates structural and functional similarity and clinical data to confirm that there are no clinically meaningful differences in safety, purity, and potency between reference products and biosimilars.2,3

Have questions about the approval process?

Structural testing video

One-minute video describing the important steps during the structural testing phase of the rigorous biosimilar approval process.

The Structural Testing Phase of the Rigorous Biosimilar Approval Process
Learn more

Functional testing video

One-minute video describing the important steps during the functional testing phase of the rigorous biosimilar approval process.

The Functional Testing Phase of the Rigorous Biosimilar Approval Process
Learn more

Clinical testing video

One-minute video describing the important steps during the clinical testing phase of the rigorous biosimilar approval process.

The Clinical Testing Phase of the Rigorous Biosimilar Approval Process
Learn more

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

References: 1. US Food and Drug Administration. Biosimilar development, review, and approval. October 20, 2017. Accessed March 2, 2023. https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval 2. Biosimilar development process. US Food and Drug Administration. Accessed March 2, 2023. https://www.fda.gov/files/drugs/published/Biosimilar-Development-Process.pdf 3. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. US Food and Drug Administration. April 2015. Accessed May 7, 2023. https://www.fda.gov/media/82647/download