Biosimilar Development
Could biosimilars be a reliable option for your institution?
Based on a foundation of science
Before a manufacturer applies for FDA approval of a proposed biosimilar, the biosimilar 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 one approved indication of the reference biologic
A biosimilar must show that it has no clinically meaningful differences in safety, purity, and potency compared with the reference biologic.1
More biosimilars are being developed every year
Biosimilar Product Development Programs Registered With the FDA (by fiscal year)2,3,a
a As of September 2020.
For biosimilars to fulfill their potential to reduce the cost of biologic medicines, it will take the collective efforts of individual institutions and pharmacy directors leading the way through the adoption of biosimilars into their formularies.4
What steps are involved in biosimilar approval?
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.
FDA, US Food and Drug Administration.
References: 1. US Food and Drug Administration. Biosimilar development, review, and approval. October 20, 2017. Accessed April 5, 2021. https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval 2. Jenkins J. Office of New Drugs, Center for Drug Evaluation and Research. Biosimilars in the US: progress and promise. DIA Biosimilars 2016. October 27, 2016. Accessed April 5, 2021. https://wayback.archive-it.org/7993/20170405202142/https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM526935.pdf 3. US Food and Drug Administration. FDA-TRACK: Biosimilars dashboard. Updated December 7, 2020. Accessed April 5, 2021. https://www.fda.gov/about-fda/fda-track-agency-wide-program-performance/fda-track-center-drug-evaluation-research-pre-approval-safety-review-biosimilars-dashboard 4. Mulcahy AW, Hlávka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Accessed May 11, 2021. https://www.rand.org/content/dam/rand/pubs/perspectives/PE200/PE264/RAND_PE264.pdf
