Biosimilar-Substitution Restrictions Head To Pa. Senate

Law360, Chicago (November 15, 2013, 8:31 PM EST) -- A Pennsylvania Senate committee on Wednesday advanced legislation that would restrict substitution of biosimilars for their brand-name counterparts, one of many comparable bills that are moving through statehouses across the country and drawing criticism from regulators and the generics industry.

The central provision of the bill, like its counterparts in other states, allows pharmacists to substitute biosimilars for a pioneer biologic only when U.S. Food and Drug Administration deems the treatments functionally interchangeable. Biosimilars, also known as follow-on biologics, serve as the generic equivalent of biologic...
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