BioPharm June eBook: Single-Use Systems

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8 BioPharm International eBook June 2018 Promotive/ Biosimilars and Biobetters Strategies and Challenges Biosimilars and biobetters have their own unique manufacturing strategies and challenges. B oth biosimilars and biobetters are biological products that are developed based on a refer- ence product already on the market (a bio- logic new molecular entity [NME]). They differ from each other, however, particularly in the regulatory pathway each would take to commercializa- tion (1,2). A biosimilar is considered highly similar to the refer- ence product and is expected to have no clinically mean- ingful 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. BIOSIMILAR VS. BIOBETTER A biosimilar commonly refers to a protein-derived medi- cine that is deliberately manufactured to be as similar as possible to the original biological product. "It should be born in mind that protein contained within biological medicines exists not as one unique species but as a population of closely related spe- cies due to various modifications to the component amino acids and often addition of varying short branched chains of sugars to one or more of these FELIZA MIRASOL Single-Use Systems Manufacturing

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