Purple Book reference family · 351(a) biologic
etuvetidigene autotemcel (waskyra)
etuvetidigene autotemcel is an FDA-licensed reference biologic from Fondazione Telethon Ets.
351(a) biologicBLA 125846 Fondazione Telethon Ets
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 125846
waskyra etuvetidigene autotemcel
Fondazione Telethon Ets
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference etuvetidigene autotemcel product.
8 mo ago
etuvetidigene autotemcel: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for etuvetidigene autotemcel.
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