Another Biosimilar Legislative Defeat for Amgen & Genentech

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Once again, a state legislature has defeated a controversial push by some of the largest biotechs to establish new requirements for biosimilar substitution. The latest vote took place late last week in Florida, where the legislature approved a bill that follows current substitution practices for prescription medicines, rather than a measure that would have created new barriers to substitution. The outcome is a defeat for Amgen (AMGN) and Genentech, which have been lobbying more than a dozen states in hopes of thwarting rivals from having easy entre to their lucrative markets. As noted previously, the bills propose that a biosimilar must have been deemed by the FDA to be interchangeable with the prescribed medicine for the specified indicated use, even though the FDA has not yet approved a biosimilar or decided whether a biosimilar is interchangeable with a brand-name biologic.

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