Getting into action

What FDA’s Biosimilars Action Plan does and doesn’t do

In its Biosimilars Action Plan, FDA promises to address most of the hot button regulatory issues that have slowed development of biosimilars and interchangeable biologics for the U.S. market. FDA can do little, however, to help biosimilars manufacturers cut through patent thickets or overcome commercial barriers that original biologics manufacturers are using to protect market share.

The action plan outlines FDA’s regulatory agenda, including providing more clarity on the data FDA requires to approve a biosimilar, and revising its guidance on demonstrating interchangeability (see “Sidebar: Planning for Action”).

Sidebar: Planning for action

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