TYENNE biosimilars — when can they launch?
TYENNE (TOCILIZUMAB-AAZG) · BLA761275 · FRESENIUS KABI USA
Where TYENNE sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for TYENNE extends to 2036 (10 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 TYENNE
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by FRESENIUS KABI USA) | 2024-03-05 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2028-03-05 | Future |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2036-03-05 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See TYENNE on Drug Landscape for the full patent picture.
Other FRESENIUS KABI USA biologics
- CHORIONIC GONADOTROPIN — exclusivity to 1985-03-05
- STIMUFEND — exclusivity to 2034-09-01
- IDACIO — exclusivity to 2036-01-05
- OTULFI — exclusivity to 2037-04-30
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- TYENNE drug profile — full patent estate, indications, clinical trials
- FRESENIUS KABI USA 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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