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FDA Continues to Approve Biosimilars

By Kevin E. Noonan — The prevailing attitude in many quarters is that the Biologics Price Competition and Innovation Act (BPCIA) has not facilitated approval of drugs biosimilar to reference biologic drug products with sufficient alacrity and has not reduced biologic drug prices that was the hope and justification for its enactment. For example, on February 3rd, the Federal Trade Commission and Food and Drug Administration issued a Joint Statement aimed at advancing competition in the biologic drug market. Earlier, the FDA itself had issued a Biosimilars Action Plan (BAP) providing specific goals to accelerate biosimilars competition, and the Trump…

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