LYUMJEV biosimilars — when can they launch?
LYUMJEV (Insulin Lispro-aabc) · BLA761109 · ELI LILLY AND CO
Where LYUMJEV sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for LYUMJEV extends to 2032 (6 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 LYUMJEV
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by ELI LILLY AND CO) | 2020-06-15 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2024-06-15 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2032-06-15 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See LYUMJEV on Drug Landscape for the full patent picture.
Other ELI LILLY AND CO biologics
- CYRAMZA — exclusivity to 2026-04-21
- TRULICITY — exclusivity to 2026-09-18
- HUMALOG KWIKPEN — exclusivity to 2027-05-26
- BASAGLAR KWIKPEN — exclusivity to 2027-12-16
- TALTZ — exclusivity to 2028-03-22
- EMGALITY — exclusivity to 2030-09-27
- OMVOH — exclusivity to 2035-10-26
- EBGLYSS — exclusivity to 2036-09-13
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- LYUMJEV drug profile — full patent estate, indications, clinical trials
- ELI LILLY AND CO 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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