ONTRUZANT biosimilars — when can they launch?
ONTRUZANT (TRASTUZUMAB-DTTB) · BLA761100 · SAMSUNG BIOEPIS CO LTD
Where ONTRUZANT sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for ONTRUZANT extends to 2031 (5 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 ONTRUZANT
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by SAMSUNG BIOEPIS CO LTD) | 2019-01-18 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2023-01-18 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2031-01-18 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See ONTRUZANT on Drug Landscape for the full patent picture.
Other SAMSUNG BIOEPIS CO LTD biologics
- RENFLEXIS — exclusivity to 2029-04-21
- ADALIMUMAB-BWWD — exclusivity to 2031-07-23
- BYOOVIZ — exclusivity to 2033-09-17
- USTEKINUMAB-TTWE — exclusivity to 2036-06-28
- EPYSQLI — exclusivity to 2036-07-19
- USTEKINUMAB-TTWE — exclusivity to 2037-04-30
- OSPOMYV — exclusivity to 2037-10-29
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- ONTRUZANT drug profile — full patent estate, indications, clinical trials
- SAMSUNG BIOEPIS CO LTD 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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