Developing a biosimilar is far more nuanced and complex than developing a generic drug(1). Biosimilars are produced through an intricate, multi-step process, using living cells(2,3).
This manufacturing information for the reference product is proprietary(4,5). The biosimilar manufacturer must therefore develop a new cell line and manufacturing parameters that result in a highly similar product(6).
Read our additional resources below for more information on the manufacturing process.
Biosimilars Hot Topic: Biologic Comparability Testing Versus Demonstration of Biosimilarity
References: 1. United States Food and Drug Administration. Generic Drug Facts. 2018. 2. Desanvicente-Celis. Immunotherapy. 2012. 1843-B-2; 1844-A-1i 3. Dranitsaris. Drugs. 2011. 1527-B-1; 1528-Figure 1 4. Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin. 2012;28:1053-1058 5. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411-419. 6. United States Food and Drug Administration. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. 2015.