Yesterday, the FDA released additional educational material to aid patients and caregivers in understanding how biosimilars are approved and to explain the differences between and among original biologic products and biosimilars. With more and more biosimilar products hitting the market, these educational tools are designed to make the public more aware of options that they may have for treatment to save money without worry of differences in safety or efficacy if their medications are switched. The Agency says that the awareness program is intended to provide information to educate patients in the following areas:
- Original biologics (reference products), biosimilars, and interchangeable products
- How FDA‑approved biosimilar medications are as safe and effective as the original biologics
- 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
The new educational program, titled Biosimilar Basics for Patients, is available in both Spanish and English, and can be found here. It explains what an original biologic is, why batch‑to‑batch product differences occur even in original biologics, what a biosimilar is, and what it means if a biosimilar has an interchangeable designation.
Expect the FDA to continue to provide additional educational materials regarding biosimilar medications and their place in the market in its continuous effort to update the public about the approval process and the value these medications can provide.
