FDA biosimilar interchangeability rule eliminated under HR 5526

What does this do?

HR 5526 eliminates the separate FDA approval step that biosimilars must currently pass to be labeled interchangeable with a brand-name biological drug. Once a biosimilar is approved as safe and sufficiently similar to the original, it is automatically considered interchangeable. The change takes effect 60 days after enactment and applies to biosimilars already on the market at that time.

Who does it affect?

Patients who take biological drugs are most directly affected, as pharmacists would be able to substitute lower-cost biosimilars without a new prescription. Brand-name biological drug manufacturers and biosimilar makers are also affected, and the FDA must update its guidance documents within 18 months.

Why does it matter?

Removing the extra approval step could increase the number of biosimilars eligible for pharmacy-level substitution, which may introduce more competition in the market for biological drugs. Existing exclusivity protections earned by biosimilar companies for being first to achieve interchangeable status remain in force until they expire.

Where does it stand?