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The Food and Drug Administration is tired of waiting.  

Of the 11 biosimilars approved by the agency, only three are available on the U.S. market.  The therapies are poised to provide patients with additional – and potentially lower-cost – options for treating rheumatoid arthritis, Crohn’s disease, cancer and other diseases.  But not unless patients can access them.

Now FDA Commissioner Scott Gottlieb, MD, has a plan to make that possible. Saying the agency won’t wait “a decade or more” for real biosimilar competition, Commissioner Gottlieb laid out his Biosimilars Action Plan on Wednesday during an address to the Brookings Institute. The plan aims to foster a more competitive biosimilars market by:



Commissioner Gottlieb alluded to specific steps such as strengthening partnerships with regulatory authorities abroad and creating a standard template for reviewing biosimilars and interchangeable products. He also reported that the FDA would work with the Federal Trade Commission to address what he called “anti-competitive behavior.”

But making biosimilars more widely available requires collaboration.  “The FDA can’t do it alone,” Commissioner Gottlieb emphasized. He acknowledged the importance of education for patients and physicians alike.

Commissioner Gottlieb also announced that the agency had finalized guidance on biosimilar labeling.  The labels, or prescribing information, guide health care providers on safe use of the medications. Despite calls for transparency, the FDA determined that labels for biosimilars will include clinical trials data from the reference biologic – not data from trials of the actual biosimilar.  FDA’s approach resembles the approach taken with FDA labels for generic versions of traditional drugs, even though biosimilars are not identical to their reference products in the same way.

The labels will also include a statement about immunogenicity, which is the tendency of biological drugs to affect patients’ immune systems, and a statement identifying the drug as a biosimilar.

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