EMPLICITI biosimilars — when can they launch?
EMPLICITI (elotuzumab) · BLA761035 · BRISTOL MYERS SQUIBB
Where EMPLICITI sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for EMPLICITI expires in 2027 (2 years 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 EMPLICITI
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by BRISTOL MYERS SQUIBB) | 2015-11-30 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2019-11-30 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2027-11-30 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See EMPLICITI on Drug Landscape for the full patent picture.
Other BRISTOL MYERS SQUIBB biologics
- ORENCIA — exclusivity to 2017-12-23
- Prolia/Xgeva — exclusivity to 2023-03-25
- NULOJIX — exclusivity to 2023-06-15
- Opdivo — exclusivity to 2026-12-22
- OPDUALAG — exclusivity to 2034-03-18
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- EMPLICITI drug profile — full patent estate, indications, clinical trials
- BRISTOL MYERS SQUIBB 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 EMPLICITI biosimilar entry
Daily alerts when BPCIA exclusivity, ref-product patents, or biosimilar applications change. Free 3 watches, Pro 50.