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FDA Purple Book · Reference family

brodalumab (Siliq)

brodalumab is an FDA-licensed reference biologic from Bausch Health Ireland, Limited. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2017

Reference approved

Reference product

351(a)BLA 761032

Siliq brodalumab

Bausch Health Ireland, Limited

Approved
Feb 15, 2017
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

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

  1. Reference approval

    Approval date of the reference brodalumab product.

    9 yr 5 mo ago

Frequently asked questions

Are there biosimilars approved for brodalumab (Siliq)?

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

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