PROLIA biosimilars — when can they launch?
PROLIA (DENOSUMAB) · BLA125320 · AMGEN
Where PROLIA sits in the biosimilar timeline
BPCIA reference product exclusivity for PROLIA expired in 2022. Biosimilars are eligible for FDA 351(k) approval in the US. Active biosimilar applications and approvals will appear here as they're filed.
Under the US Biologics Price Competition and Innovation Act (BPCIA), a reference biologic is protected from biosimilar competition for 12 years from FDA approval (with 4 years of data exclusivity preventing 351(k) submissions). Biosimilars enter via the abbreviated 351(k) pathway, which requires comparability — not exact identity — to the reference product.
Key dates for PROLIA
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by AMGEN) | 2010-06-01 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2014-06-01 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2022-06-01 | Past |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See PROLIA on Drug Landscape for the full patent picture.
Other AMGEN biologics
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- PROLIA drug profile — full patent estate, indications, clinical trials
- AMGEN patent portfolio
Not legal advice. BPCIA exclusivity may interact with composition-of-matter patents and patent term extensions — see the full drug profile for the consolidated picture.
Track PROLIA biosimilar entry
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