FDA Purple Book · Reference family
peginterferon alfa-2a (Pegasys)
peginterferon alfa-2a is an FDA-licensed reference biologic from pharmaand GmbH. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2011
Reference approved
Reference product
351(a)BLA 103964
Pegasys peginterferon alfa-2a
pharmaand GmbH
- Approved
- Sep 29, 2011
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for peginterferon alfa-2a, in chronological order.
Reference approval
Approval date of the reference peginterferon alfa-2a product.
14 yr 11 mo ago
Frequently asked questions
Are there biosimilars approved for peginterferon alfa-2a (Pegasys)?
No 351(k) biosimilars or interchangeable biosimilars referencing peginterferon alfa-2a are listed in the FDA Purple Book yet.
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