Purple Book product · Reference 351(a)

Palynziq

pegvaliase-pqpz

351(a)BLA 761079RxLicensed BioMarin Pharmaceutical Inc.

View pegvaliase-pqpz family Label PDF Open on FDA Purple Book

May 24, 2018

Approved

Reference 351(a)

License type

Marketing

None

Listed patents

Palynziq (pegvaliase-pqpz) is BioMarin Pharmaceutical Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2018. No biosimilars referencing Palynziq are listed in the Purple Book yet.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
May 24, 2018
8 yr 3 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
May 24, 2025
1 yr 2 mo ago
Today

Pharmaceutical detail

Strength

2.5MG/0.5ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

1649

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.

2 additional BLA records for this product (other strengths or presentations) are in the same reference family.

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Palynziq have approved biosimilars?

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

What is Palynziq's BLA number?

Palynziq is licensed under BLA 761079, held by BioMarin Pharmaceutical Inc..

When was Palynziq approved by the FDA?

Palynziq was approved by the FDA on May 24, 2018.

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