AVSOLA biosimilars — when can they launch?
AVSOLA (INFLIXIMAB-AXXQ) · BLA761086 · AMGEN INC
Where AVSOLA sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for AVSOLA extends to 2031 (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 AVSOLA
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by AMGEN INC) | 2019-12-06 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2023-12-06 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2031-12-06 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See AVSOLA on Drug Landscape for the full patent picture.
Other AMGEN INC biologics
- MVASI — exclusivity to 2029-09-14
- AIMOVIG — exclusivity to 2030-05-17
- EVENITY — exclusivity to 2031-04-09
- Ilumya — exclusivity to 2031-06-13
- RIABNI — exclusivity to 2032-12-17
- REPATHA — exclusivity to 2033-02-26
- WEZLANA — exclusivity to 2035-10-31
- WEZLANA — exclusivity to 2035-10-31
- IMDELLTRA (AMG757) — exclusivity to 2036-05-16
- BKEMV — exclusivity to 2036-05-28
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- AVSOLA drug profile — full patent estate, indications, clinical trials
- AMGEN 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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