FDA Purple Book · Reference family
peginterferon beta-1a (Plegridy)
peginterferon beta-1a is an FDA-licensed reference biologic from Biogen Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2014
Reference approved
Reference product
351(a)BLA 125499
Plegridy peginterferon beta-1a
Biogen Inc.
- Approved
- Aug 15, 2014
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for peginterferon beta-1a, in chronological order.
Reference approval
Approval date of the reference peginterferon beta-1a product.
12 yr ago
Frequently asked questions
Are there biosimilars approved for peginterferon beta-1a (Plegridy)?
No 351(k) biosimilars or interchangeable biosimilars referencing peginterferon beta-1a are listed in the FDA Purple Book yet.
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