Biosimilar Development

Could biosimilars be a reliable option for your institution?

Biosimilar Development

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

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

Biosimilars Go Through a Rigorous Development and Testing Process
Comparative Clinical Studies to Confirm Biosimilarity

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

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.

More Biosimilars Are Being Developed Every Year
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.

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.

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.

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.

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