Abstract
Biologic therapies represent a drug class toward which there is continued development and production in a number of disease states. The development of an approval pathway allowing for the introduction of biosimilars into the US pharmaceutical market poses new challenges for health care systems and institutions. The potential difference in cost is a major driver for the development and use of biosimilars in practice. The manufacturing process for biosimilar compounds is complicated and requires specific detailing of each step, including development of the large-molecular component. Requirements for safe manufacturing of these therapies are crucial, as downstream effects may influence clinical efficacy and immunological properties. As these therapies enter the US marketplace, health care professionals will be asked to take prudent measures as they consider and evaluate these therapies for substitution into their formularies.
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