PHESGO biosimilars — when can they launch?
PHESGO (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) · BLA761170 · GENENTECH INC
Where PHESGO sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for PHESGO 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 PHESGO
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by GENENTECH INC) | 2020-06-29 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2024-06-29 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2032-06-29 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See PHESGO on Drug Landscape for the full patent picture.
Other GENENTECH INC biologics
- Tecentriq — exclusivity to 2028-05-18
- Ocrevus — exclusivity to 2029-03-28
- HEMLIBRA — exclusivity to 2029-11-16
- HERCEPTIN HYLECTA — exclusivity to 2031-02-28
- VABYSMO — exclusivity to 2034-01-28
- LUNSUMIO — exclusivity to 2034-12-22
- COLUMVI — exclusivity to 2035-06-15
- PIASKY — exclusivity to 2036-06-20
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- PHESGO 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.
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