CRYSVITA biosimilars — when can they launch?
CRYSVITA (BUROSUMAB-TWZA) · BLA761068 · KYOWA KIRIN
Where CRYSVITA sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for CRYSVITA extends to 2030 (4 years from today). Biosimilars cannot be approved by the FDA before this date. Biosimilar developers begin clinical comparability studies 4-6 years before the cliff.
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 CRYSVITA
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by KYOWA KIRIN) | 2018-04-17 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2022-04-17 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2030-04-17 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See CRYSVITA on Drug Landscape for the full patent picture.
Other KYOWA KIRIN biologics
- POTELIGEO — exclusivity to 2030-08-08
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- CRYSVITA drug profile — full patent estate, indications, clinical trials
- KYOWA KIRIN 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.
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