HERCEPTIN HYLECTA biosimilars — when can they launch?
HERCEPTIN HYLECTA (Trastuzumab and Hyaluronidase-oysk) · BLA761106 · GENENTECH INC
Where HERCEPTIN HYLECTA sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for HERCEPTIN HYLECTA 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 HERCEPTIN HYLECTA
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by GENENTECH INC) | 2019-02-28 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2023-02-28 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2031-02-28 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See HERCEPTIN HYLECTA on Drug Landscape for the full patent picture.
Other GENENTECH INC biologics
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- HERCEPTIN HYLECTA drug profile — full patent estate, indications, clinical trials
- GENENTECH INC 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 HERCEPTIN HYLECTA biosimilar entry
Daily alerts when BPCIA exclusivity, ref-product patents, or biosimilar applications change. Free 3 watches, Pro 50.