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Biosimilars and biobetters have their own unique manufacturing strategies and challenges.
Both biosimilars and biobetters are biological products that are developed based on a reference product already on the market (a biologic new molecular entity [NME]). They differ from each other, however, particularly in the regulatory pathway each would take to commercialization (1,2). A biosimilar is considered highly similar to the reference product and is expected to have no clinically meaningful differences in terms of safety, purity, and potency; whereas, a biobetter is a product that is in some way an improvement over an existing biological product, such as by the use of an improved delivery system, improved formulation, or other modification that enhances efficacy and safety.
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When referring to this article, please cite it as F. Mirasol, “Biosimilars and Biobetters Strategies and Challenges,” BioPharm International Single-Use Systems eBook (June 2018).