OPDUALAG biosimilars — when can they launch?
OPDUALAG (RELATLIMAB-RMBW) · BLA761234 · BRISTOL MYERS SQUIBB
Where OPDUALAG sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for OPDUALAG extends to 2034 (8 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 OPDUALAG
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by BRISTOL MYERS SQUIBB) | 2022-03-18 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2026-03-18 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2034-03-18 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See OPDUALAG 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
- EMPLICITI — exclusivity to 2027-11-30
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- OPDUALAG 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 OPDUALAG biosimilar entry
Daily alerts when BPCIA exclusivity, ref-product patents, or biosimilar applications change. Free 3 watches, Pro 50.