Trump Administration Eases Approval Process for Biosimilar Drugs

The Trump administration is proposing changes to Food and Drug Administration guidelines that would make it less expensive for drugmakers to develop biosimilar medicines, the copycat versions of off-patent biologic drugs. Under the new draft guidance, FDA would no longer require all biosimilar manufacturers to run clinical trials of their drugs as a condition of approval. Instead, the FDA says it will look at analytical studies that can show whether or not the biosimilar matches the branded drug it seeks to copy.

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