March 22, 2023
Today, the U.S. Food and Drug Administration
released new educational materials for patients related to biosimilars and
interchangeable biosimilars –
two fact sheets: Biosimilars What Patients Need to
Know, Biosimilars What Patients with
Diabetes Need to Know, and an infographic: Biosimilar Basics Infographic for
Patients.
The materials for patients are also available in Spanish: Biosimilares: Lo Que los Pacientes
Deben Saber, Biosimilares: Lo Que los Pacientes con
Diabetes Deben Saber, and Conceptos Básicos Sobre los
Biosimilares.
FDA developed these materials to educate patients and increase awareness
of:
- Original biologics
(reference products), biosimilars and interchangeable products - How FDA approved
biosimilar medications are as safe and effective as the original
biologic - Additional
treatment options for patients with many illnesses such as: diabetes,
psoriasis, Crohn’s disease, ulcerative colitis, rheumatoid arthritis,
kidney conditions, macular degeneration, and cancer - How
biosimilars can provide more treatment options and potentially reduce
costs for patients
A biosimilar is a biological product (biologic) that is highly
similar to another FDA-approved biologic, called a reference product. Biosimilars
have no clinically meaningful differences from their reference product in terms
of safety, purity, and potency (safety and effectiveness). An interchangeable
product is a biosimilar that may be substituted without consulting the
prescribing doctor, because it meets additional requirements related to the
potential for automatic substitution, depending on state pharmacy laws.
For more information about biosimilars and additional resources for patients,
visit the Basics for Patients webpage.
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