FDA Purple Book · Reference family
interferon alfa-2a (Roferon-A)
interferon alfa-2a is an FDA-licensed reference biologic from Hoffmann-La Roche Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1986
Reference approved
Reference product
351(a)BLA 103145
Roferon-A interferon alfa-2a
Hoffmann-La Roche Inc.
- Approved
- Jun 04, 1986
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for interferon alfa-2a, in chronological order.
Reference approval
Approval date of the reference interferon alfa-2a product.
40 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for interferon alfa-2a (Roferon-A)?
No 351(k) biosimilars or interchangeable biosimilars referencing interferon alfa-2a are listed in the FDA Purple Book yet.
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