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. https://www.fda.gov/media/108103/download
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
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
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. https://www.fda.gov/media/108557/download 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. https://www.fda.gov/media/82647/download 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. https://www.fda.gov/files/drugs/published/FDA%E2%80%99s-Overview-of-the-Regulatory-Guidance-for-the-Development-and-Approval-of-Biosimilar-Products-in-the-US.pdf 4. Biosimilars Action Plan. Balancing innovation and competition. US Food and Drug Administration. July 2018. Accessed March 22, 2023. https://www.fda.gov/media/114574/download