FDA looks to reform biosimilar approval

The U.S. Food and Drug Administration has introduced draft guidance to create a quicker and more cost-effective path for biosimilar development and approval.

Among the changes, the FDA outlined the simplification of comparative efficacy studies that often take up to three years and cost about $24 million, the removal of recommendations to perform switching studies, and the reduction of unnecessary and resource-intensive clinical trials — without sacrificing safety and effectiveness of the biosimilars.

Reforms to the biosimilar development process could provide pharmacists and patients with opportunities to access lower-cost biosimilars.

Read more: FDA

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