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FDA Purple Book · Reference family

etuvetidigene autotemcel (waskyra)

etuvetidigene autotemcel is an FDA-licensed reference biologic from Fondazione Telethon Ets. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2025

Reference approved

Reference product

351(a)BLA 125846

waskyra etuvetidigene autotemcel

Fondazione Telethon Ets

Approved
Dec 09, 2025
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for etuvetidigene autotemcel, in chronological order.

  1. Reference approval

    Approval date of the reference etuvetidigene autotemcel product.

    6 mo ago

Frequently asked questions

Are there biosimilars approved for etuvetidigene autotemcel (waskyra)?

No 351(k) biosimilars or interchangeable biosimilars referencing etuvetidigene autotemcel are listed in the FDA Purple Book yet.

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