Building Trust
with Biosimilars

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
development:

Demonstrate the efficacy and safety of a proposed product.³

Preclinical research

Clinical trial—Phase I

Clinical trial—Phase II

Clinical trial—Phase III

When a biologic is proposed for an established originator biologic^2,3

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

Discover the building blocks of biosimilarity

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

Biosimilar approval is supported by a rigorous demonstration of similarity

The development and approval process for biosimilars involves comprehensive comparative testing with an approved reference product. Every step of the rigorous process helps provide evidence to support FDA approval.¹

What does
biosimilarity mean?

No clinically meaningful differences between the biosimilar and its reference biologic in terms of safety, purity and potency

How is biosimilarity measured?¹

Molecular structure

Mechanisms of action

Pharmacodynamics

Pharmacokinetic interactions

Distribution in the body

Immune responses

Overall effectiveness and safety

This rigorous demonstration helps support the reliability of biosimilarity.^1,2

Learn more about the appropriate patients for biosimilars

FDA, US Food and Drug Administration

Which patients are appropriate
for a biosimilar?

The FDA approves a biosimilar for the same use as its reference biologic, often with the same indications and mechanisms of action. The appropriate patients for biosimilars may be new patients as well as patients with a history on biologics.¹

When a biosimilar is used appropriately, patients and their prescribers may rely on there being¹:

No clinically meaningful differences between the biosimilar and its reference biologic in terms of safety, purity and potency

If a patient is considered appropriate for a biologic, they may be appropriate for a biosimilar.¹

Discover the building blocks of biosimilarity

FDA, US Food and Drug Administration

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

Make an Impact with Biosimilars

How are biosimilars developed, and who are the appropriate patients?

An FDA-approved biosimilar will have been supported by a rigorous demonstration of similarity to an originator biologic.^1,2

This process demonstrates no clinically meaningful differences between the proposed biosimilar and the reference biologic in terms of safety, purity, and potency.¹

An appropriate patient for a reference biologic may also be appropriate for its biosimilar.²

How can your institution make an impact? As more practices and institutions adopt biosimilars with confidence, the potential for increased access and decreased costs to the health care system grows.³

Additional Biosimilars Resources

Download a comprehensive roadmap for adopting biosimilars.

Biosimilars roadmap—for institutions

Roadmap for health care professionals for considering, implementing, and monitoring biosimilar adoption in an institution.

Download Learn more

Biosimilars roadmap—for physicians

Roadmap for health care professionals for considering, implementing, and monitoring biosimilar adoption in a private practice setting.

Download Learn more

FDA, US Food and Drug Administration

References: 1. 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/downloads/drugs/guidances/ucm291128.pdf 2. Prescribing biosimilar products. US Food and Drug Administration. Updated October 23, 2017. Accessed March 22, 2023. https://www.fda.gov/media/108103/download 3. Mulcahy AW, Hlávka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Published October 22, 2017. Accessed March 22, 2023. https://www.rand.org/content/dam/rand/pubs/perspectives/PE200/PE264/RAND_PE264.pdf

Building Trust with Biosimilars

What are the goals of biosimilar development?

Goal of originator biologic development:

Goal of biosimilar development:

Discover the building blocks of biosimilarity

Building Trust
with Biosimilars

Goal of originator biologic
development: