This site is intended for U.S. health care professionals.
This site is intended for U.S. health care professionals.

Adopting biosimilars

We’re here to set you and your patients up for success. That’s why we’re committed to answering any questions you have about the biosimilar transitioning process.

Need help navigating the adoption
process in your practice?

Our difference lies in understanding yours. We’re committed to building a biosimilars experience tailored to your needs, however unique they are. In the interim, these resources can help you understand how biosimilars can fit into your processes, whether you’re an institution or a private practice.

Biosimilars Roadmap - For Institutions

For institutions

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

Biosimilars Roadmap - For Physicians

For physicians

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

Spearheading implementation

Before adding any medicine onto formulary, nearly every organization relies on its pharmacy and therapeutics (P&T) committee to conduct a broad and detailed evaluation of the product, including biosimilars.

Key elements of biosimilar formulary review include:

Biosimilar Formulary Review - Clinical Parameters

Clinical parameters1

  • Indication, MOA, and dosing and administration
  • Clinical effectiveness and safety
  • Immunogenicity
Biosimilar Formulary Review - Product Characteristics

Product
characteristics1

  • Nomenclature
  • Supply chain
  • Packaging/Labeling
Biosimilar Formulary Review - Considerations

Considerations1

  • Cost/Reimbursement
  • Pharmacovigilance
  • Patient/Provider education
  • Tracking and information system implications

Understanding interchangeability

What is interchangeability?

An interchangeable product is a biosimilar that may be substituted for a reference product without the intervention of the prescribing health care provider, depending on state pharmacy laws.2

What does it mean in practice?

The “interchangeable” designation permits pharmacists to switch to an interchangeable biosimilar without the knowledge or approval of the prescriber. State laws that address substitution of biological products at the pharmacy vary; therefore, it is important for prescribers and pharmacists to understand the pharmacy practices in their state.2

Understanding the role of real-world experience with biosimilars

When considering a biosimilar, real-world experience can provide insight into its use in a real-world setting. As multiple biosimilars enter the market, pharmacist, physician, and patient education—as well as a continued emphasis on real-world experience—are important factors.

Biosimilar resources for health care system pharmacists

Advocating for Biosimilars

Interactive educational resource for pharmacists exploring the potential value biosimilars may bring to the health care system.

Confidence in Biosimilars

Interactive educational resource for pharmacists providing an overview of clinical considerations for biosimilars.

Championing Biosimilars

Interactive educational resource discussing the role health system pharmacists play in the successful implementation of biosimilars.

MOA, mechanism of action.

References: 1. Ventola CL. Evaluation of biosimilars for formulary inclusion: factors for consideration by P&T committees. P T. 2015;40(10):680-689. 2. Biosimilar and interchangeable products: foundational concepts level 1. US Food and Drug Administration. Accessed March 28, 2023. https://www.fda.gov/media/154995/download