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Insurance, rules and care

Biosimilar

A biosimilar is an FDA-approved copy of a biologic medicine, such as insulin, that is highly similar to the original with no meaningful clinical differences.

Updated Insurance, rules and care
DefinitionA biosimilar is an FDA-approved copy of a biologic medicine, such as insulin, that is highly similar to the original with no meaningful clinical differences.

What it means

Biologics are large, complex molecules, usually proteins made in living cells. Exact copies are not possible, so the FDA approves "highly similar" versions called biosimilars. Some are also approved as interchangeable, meaning a pharmacist can swap them for the brand where state law allows.

Insulin moved to the biologic pathway in 2020, and biosimilar and interchangeable insulins now exist. Dulaglutide (Trulicity), which is fused to part of an antibody, is also regulated as a biologic.

Semaglutide, tirzepatide and liraglutide are peptides of 40 amino acids or fewer, so they are regulated as drugs. Copies of them go through the generic pathway, not the biosimilar one. Calling a semaglutide product a "biosimilar" is a sign of confusion or marketing.

Biosimilars may cost less, but price depends on your plan.

Why it matters

The biosimilar and generic paths explain which GLP-1 copies are possible and when they might arrive.

Related terms

Sources

  1. FDA: Biosimilars basics for patients