FDA Biosimilar Action Plan Mostly Expands On Existing Initiatives

July 18, 2018 at 7:55 PM
FDA released a long-awaited Biosimilars Action Plan Wednesday (July 18) that promises new development tools for biosimilars makers, additional educational resources and a public hearing dedicated to biosimilar competition, among other initiatives. While the plan mostly expands on existing FDA plans, stakeholders are encouraged by the agency’s public commitment to supporting the biosimilar market. FDA Commissioner Scott Gottlieb once again took on multiple drug industry actors for thwarting biosimilar competition. “Consolidation across the supply chain has made it more attractive...


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