Lawmakers Question FDA’s Grasp of Biosimilars Legislation

As the FDA continues its internal deliberations over how to regulate biosimilars, the principal authors of the bill that created the approval pathway have written to the agency seeking to clarify what they see as an error in the FDA’s interpretation of the law. In a letter sent last month, Reps. Anna Eshoo (D-Calif.), Jay Inslee (D-Wash.) and Joe Barton (R-Texas) express concern that FDA officials are confused about the 12-year period of data exclusivity that was granted to manufacturers of brand biologics when President Barack Obama signed the Patient Protection and Affordable Care Act into law last year.
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