Biosimilars are biologic medicines that are highly similar to existing licensed biologic products with no clinically meaningful differences in terms of safety and efficacy(1,2).
Biosimilars are manufactured in living cell lines using processes that cannot be exactly replicated from one manufacturer to the next(3). Therefore, a biosimilar, unlike a small-molecule generic, is not an exact copy of its reference product(4).
Want to learn even more about biosimilars? Read through our resources below for more information.
Developing the Totality of Evidence for Biosimilars: Regulatory Considerations for the Health Care Community
References: 1. United States Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. 2015. 2. European Medicines Agency. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. 2014. 3. Camacho LH, Frost CP, Abella E, et al. Biosimilars 101: considerations for U.S. oncologists in clinical practice. Cancer Med. 2014; 3:889-899. 4. United States Food and Drug Administration. Generic Drug Facts. 2018.