TRESIBA biosimilars — when can they launch?
TRESIBA (INSULIN DEGLUDEC) · BLA203314 · NOVO
Where TRESIBA sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for TRESIBA expires in 2027 (1 year from today). Biosimilar developers are typically preparing 351(k) applications 36-48 months ahead of this date. Expect first biosimilar filings to surface in this window.
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 TRESIBA
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by NOVO) | 2015-09-25 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2019-09-25 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2027-09-25 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See TRESIBA on Drug Landscape for the full patent picture.
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- TRESIBA drug profile — full patent estate, indications, clinical trials
- NOVO 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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