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:
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.
Comparative clinical studies (if necessary)1
To confirm biosimilarity of the product in patients in at least 1 approved indication of 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.
Functional testing video
One-minute video describing the important steps during the functional testing phase of the rigorous biosimilar approval process.
Clinical testing video
One-minute video describing the important steps during the clinical testing phase of the rigorous biosimilar approval process.