POLIVY biosimilars — when can they launch?
POLIVY (POLATUZUMAB VEDOTIN) · BLA761121 · GENENTECH
Where POLIVY sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for POLIVY 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 POLIVY
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by GENENTECH) | 2019-06-10 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2023-06-10 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2031-06-10 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See POLIVY on Drug Landscape for the full patent picture.
Other GENENTECH biologics
- CATHFLO ACTIVASE — exclusivity to 1999-11-13
- PULMOZYME — exclusivity to 2005-12-30
- NUTROPIN AQ NUSPIN 10 — exclusivity to 2007-12-29
- RITUXAN — exclusivity to 2009-11-26
- HERCEPTIN — exclusivity to 2010-09-25
- TNKASE — exclusivity to 2012-06-02
- XOLAIR — exclusivity to 2015-06-20
- Avastin — exclusivity to 2016-02-26
- Actemra — exclusivity to 2022-01-08
- Perjeta — exclusivity to 2024-06-08
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- POLIVY drug profile — full patent estate, indications, clinical trials
- GENENTECH 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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