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Official says removing biosimilar confirmatory trial saved time and money
Summary
The speaker told conference attendees the administration eliminated a confirmatory efficacy trial for biosimilars, estimating it saved about $300 million and shortened approvals by a couple of years.
At the conference, the agency official said the administration had removed a confirmatory efficacy trial for biosimilars, which the speaker estimated "saves about $300,000,000 or so and a couple years from the approval" of biosimilar versions of expensive biologics.
The official presented that regulatory change as an example of steps taken to increase availability and reduce costs for complex medicines. No specific examples of affected biologics were named during the remarks.
The official said similar incremental regulatory and programmatic changes on the generics side are part of a broader strategy to improve access and competition.
