Endoscopic assessment and current topics of treatment of inflammatory bowel disease
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Resumen
Biosimilars are defined as biologic products that are highly similar to reference products, notwithstanding minor differences in clinically inactive components, with no clinically meaningful differences between the biologic product and the reference product in terms of safety profile, purity, and potency. Due to the high cost of innovator biologics, as well as an increase in the number of these products reaching patent expiry, the development of a process for approving biosimilar products has become a crucial regulatory issue in the USA. Introducing competition to decrease the costs of biologics is an important component of an overall strategy to reduce healthcare costs worldwide. In 2014, total drug expenditure in the USA grew by 12% compared to the total expenditure in 2013, and it has grown by 7-9% in 2015.