FDA Finalizes Guidance on Interchangeability for Biologics

The FDA has issued the final guidance on how drug companies can create “interchangeable” biologics, AKA biosimilars. The final guidance on interchangeability is intended to provide clarity for developers who want to demonstrate that their biological product meets the statutory interchangeability standard set down in the Public Health Service Act (PHS Act), which means that it can be substituted for the brand version of the drug.

“Biologics provide important treatment options for patients with serious diseases like cancer, rheumatoid arthritis, diabetes and multiple sclerosis,” says Norman E. Sharpless, MD, the FDA’s acting commissioner, in a statement.

The FDA has been working to implement a Biosimilars Action Plan that includes several efforts to encourage innovation and competition among biologics and to develop lower-cost biosimilars. The guidance allows manufacturers to know what steps they need to take to show interchangeability.

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“This pathway is intended to benefit patients by making more treatment options available through biosimilar and interchangeable products, by increasing access to life-saving medications and potentially lowering health care costs through competition,” Sharpless says.

The FDA will approve the biological product as interchangeable with the reference product if the information submitted in the application or the supplement meets the applicable standard, that it is biosimilar to the brand (the reference product) and can be expected to produce the same clinical result as the reference product in patients.

Congress created an approval pathway for biological products In the Biologics Price Competition and Innovation Act of 2009 (BPCI Act. So far, only 19 biosimilar products have been approved by the FDA, many of which have not reached market.