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Biosimilar approval is long overdue

November 13, 2014 

Generic versions of brand-name chemically based drugs are well-established in the U.S. market. However, even though the Food and Drug Administration (FDA) was given the authority in 2010 to create a pathway to approve a “generic” version of a biologic drug, more properly called a “biosimilar,” the agency has not approved a single one.

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