Biosimilars are biologic medicines that are highly similar to existing licensed biologic products with no clinically meaningful differences in terms of safety and efficacy.1 Biosimilars offer prescribers and patients valuable additional options when it comes to treatments.1 To help, we've put together some resources and information for prescribers to better understand the safety, efficacy, and quality of biosimilars.
Resources for Healthcare Providers
What You Need to Know About Prescribing Biosimilars
A key clinical consideration is how and when biologics, including biosimilars, can be safely used. A clinician may choose to transition or switch the biologic medicine a patient is currently treated with for another biologic – either a different brand or a biosimilar – that is approved and available to treat the same condition.2 This is a decision made by a healthcare provider in consultation with the patient.2
How to Talk About Biosimilars With Your Patients
When prescribing a biosimilar to a patient, it is important to highlight that the regulatory review pathways for a biosimilar are based in science and ensure before approval that the biosimilar is as safe and effective as the reference product.3
Biosimilars and Interchangeability
Biosimilar interchangeability in the U.S. and EU refer to different things.
In the U.S., an "interchangeability" designation means that the biosimilar may be substituted for its reference product at the pharmacy in accordance with state laws.
An interchangeability designation does not mean that the designated biosimilar product is safer or more effective than other biosimilars.3
In the U.S., all 50 states, the District of Columbia and Puerto Rico, have laws that address pharmacy substitution of interchangeable biosimilars.5
In the EU, interchangeability relates to prescribing where a physician may elect to prescribe one medicine to a patient in place of another with the same therapeutic intent,2,4 The EMA has not taken a position on pharmacy substitution of biosimilars, as this is regulated at the EU member state level.4
RELATED LINKS
References:
- U.S. Food and Drug Administration. Biosimilars: Overview for Health Care Professionals. 2024. Available at: https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals
- U.S. Food and Drug Administration. Interchangeable Biological Products. Available at: https://www.fda.gov/media/151094/download#:~:text=access%20to%20biologics.-,Interchangeable%20Biosimilars,substituted%20for%20brand%2Dname%20drugs. Accessed March 31, 2025.
- U.S. Food and Drug Administration. Biosimilar Product Regulatory Review and Approval. 2019. Available at: https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf. Accessed March 31, 2025.
- EMA. Biosimilar medicine can be interchanged. Sept. 9, 2022. https://ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged. Accessed March 31, 2025.
- Cardinal Health. State laws for biosimilar interchangeability. Available at: https://www.cardinalhealth.com/en/product-solutions/pharmaceutical-products/biosimilars/state-regulations-for-biosimilar.html. Accessed March 31, 2025.