KADCYLA biosimilars — when can they launch?
KADCYLA (trastuzumab-emtansine) · BLA125427 · GENENTECH
Where KADCYLA sits in the biosimilar timeline
BPCIA reference product exclusivity for KADCYLA expired in 2025. Biosimilars are eligible for FDA 351(k) approval in the US. Active biosimilar applications and approvals will appear here as they're filed.
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 KADCYLA
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by GENENTECH) | 2013-02-22 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2017-02-22 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2025-02-22 | Past |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See KADCYLA 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
- KADCYLA 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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