AMPHADASE biosimilars — when can they launch?
AMPHADASE (HYALURONIDASE) · BLA021665 · AMPHASTAR PHARM
Where AMPHADASE sits in the biosimilar timeline
BPCIA reference product exclusivity for AMPHADASE expired in 2016. 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 AMPHADASE
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by AMPHASTAR PHARM) | 2004-10-26 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2008-10-26 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2016-10-26 | Past |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See AMPHADASE on Drug Landscape for the full patent picture.
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- AMPHADASE drug profile — full patent estate, indications, clinical trials
- AMPHASTAR PHARM 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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