What are Biologics?
Biologics are specialty drugs used to treat long-term conditions like cancer, rheumatoid arthritis, skin conditions like psoriasis, multiple sclerosis, osteoporosis, and Crohn’s
disease. They can be costly. Biologics make up only 5% of prescriptions in the U.S. but account for 51% of total drug spending as of 2024.
What are Biosimilars?
Biosimilars are medicines highly similar to an FDAapproved biologic (the “reference product”). They work the same way and have no meaningful differences in safety, effectiveness, or quality. Before FDA approval, biosimilars are tested to meet the
same standards as the original biologic. Some biosimilars are interchangeable, meaning a California pharmacist can substitute a lower-cost biosimilar, just like they do with generic drugs for brand-name medicines. For example, Humira is a widely used biologic for rheumatoid arthritis. Its biosimilar, Simlandi, works the same way and is interchangeable. On average, biosimilars cost about 50% less than the original biologic. Using a biosimilar may give you more treatment options and help lower your drug costs.
If you have questions about a biosimilar or how it may affect your treatment, talk with your healthcare provider or pharmacist. Learn more from the FDA: https://www.fda.gov/drugs/biosimilars/biosimilars-basicspatients
References:
1. U.S. Food and Drug Administration. FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs. FDA News Release. October 29, 2025.
2. “The U.S. Generic & Biosimilar Medicines Savings Report: September 2023,” Association for Accessible Medicines, September 2023.
3. U.S. Food and Drug Administration. Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. Accessed January 28, https://purplebooksearch.fda.gov/