Defining biosimilars
What are biosimilars?
Biosimilars are biologics that are highly similar—yet not identical— to a reference product. Before a biosimilar goes to market, its manufacturer must conduct studies to show it is highly similar to the reference product. Biosimilar products go through a rigorous FDA approval process to make sure they are safe, pure, and effective. From a clinical perspective, there is no meaningful difference between a reference product and its biosimilar.
What is the difference between generics and biosimilars?
Biosimilars are not generics. Generics are exact copies of synthetic pharmaceuticals and the active ingredients must be the same as a brand name drug. Biosimilars are copies of biologics, which are medications made with living cells. They can have slight differences in clinically inactive components. The important thing to remember is there is no difference in how a biosimilar and its reference product treats your patients’ conditions.
What to know about biosimilars
For providers
As a provider, you make choices every day about what medications to recommend. A biosimilar and its reference product will provide the same clinical results for your patients. We want you to feel confident in your decision to pick biosimilars for your patients. We are here to support you with innovative solutions to help increase access to emerging therapies, like biosimilars. You can help drive long-term stability in the biosimilars market. We provide easier access to biosimilars entering the market so you can make the best choice for your patients' care.
For patients
Your patients may be uncertain about biosimilars. Yet, they trust you. You can help them understand that biosimilars are safe and effective. Patients can expect the same health outcomes if you prescribe or recommend a biosimilar instead of its reference product. Biosimilars can also save patients money as they often pay less out-of-pocket. As trusted advisors, physicians, and pharmacists should recommend biosimilar use. Start a conversation with patients to answer their questions and build their trust.
Continuing education
Biosimilars 101
Resources
AP News
FDA allows automatic ‘generic’ swap for brand-name insulin
The Center for Biosimilars
Biosimilars offer savings and access for U.S. patients
ABC Order
Biosimilar catalog
FDA
Guidance and information on biosimilars
AmerisourceBergen Insights
Podcast: Insulin biosimilars part 1
The Center for Biosimilars
Putting the U.S. biosimilar industry in perspective
Additional Insights
