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FDA Purple Book · Reference family

polatuzumab vedotin-piiq (Polivy)

polatuzumab vedotin-piiq is an FDA-licensed reference biologic from Genentech, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2020

Reference approved

Reference product

351(a)BLA 761121

Polivy polatuzumab vedotin-piiq

Genentech, Inc.

Approved
Sep 18, 2020
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for polatuzumab vedotin-piiq, in chronological order.

  1. Reference approval

    Approval date of the reference polatuzumab vedotin-piiq product.

    5 yr 9 mo ago

  2. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    in 3 yr 11 mo

Frequently asked questions

Are there biosimilars approved for polatuzumab vedotin-piiq (Polivy)?

No 351(k) biosimilars or interchangeable biosimilars referencing polatuzumab vedotin-piiq are listed in the FDA Purple Book yet.

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