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FDA finalizes guidance to spur biosimilar availability
Modern Healthcare

The Food and Drug Administration on Friday gave clear suggestions for drugmakers to make it easier for patients to obtain biosimilars, treating them similarly to generic drugs.

In the final guidance, FDA gave drugmakers some clarity on the studies they need to show their biosimilar is interchangeable with a biologic. While federal law created a pathway for interchangeability, drug companies have been seeking greater guidance from the agency. Healthcare providers have called on the Trump administration and Congress to do more to increase availability of biosimilars. Biologics can cost hundreds of thousands of dollars for chronic conditions.

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