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FDA Purple Book · Reference family

bimekizumab-bkzx (Bimzelx)

bimekizumab-bkzx is an FDA-licensed reference biologic from UCB, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2024

Reference approved

Reference product

351(a)BLA 761151

Bimzelx bimekizumab-bkzx

UCB, Inc.

Approved
Oct 11, 2024
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for bimekizumab-bkzx, in chronological order.

  1. Reference approval

    Approval date of the reference bimekizumab-bkzx product.

    1 yr 8 mo ago

Frequently asked questions

Are there biosimilars approved for bimekizumab-bkzx (Bimzelx)?

No 351(k) biosimilars or interchangeable biosimilars referencing bimekizumab-bkzx are listed in the FDA Purple Book yet.

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