Biological products, or biologics, are crucial for clinical care, offering safe and effective treatments for various disorders, including vaccines, proteins, and blood products. Biosimilars, which are highly similar to FDA-approved biologics, have an abbreviated regulatory approval pathway, fostering market competition and potentially reducing drug costs. The U.S. FDA has approved 44 biosimilars for 14 reference products treating conditions like macular degeneration, rheumatoid arthritis, and cancer. Biosimilars can be prescribed for both treatment-experienced and treatment-naïve patients. Concerns about switching stable patients from a reference product to a biosimilar prompted FDA investigators to conduct a systematic review. The focus was on safety outcome differences, including deaths, serious adverse events, study discontinuations, and immunogenicity events, between individuals who switched and those who did not.1
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References
- Research, C. F. D. E. A. (2023, December 5). Safety outcomes when “Switching” between biosimilars and reference products. U.S. Food And Drug Administration. https://www.fda.gov/drugs/news-events-human-drugs/safety-outcomes-when-switching-between-biosimilars-and-reference-products
Disclaimers
- The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
- Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
- No official support by any organization(s) has been provided or should be inferred
