interferon beta-1b (Betaseron)
interferon beta-1b is an FDA-licensed reference biologic from Bayer HealthCare Pharmaceuticals Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1993
Reference approved
Reference product
Betaseron interferon beta-1b
Bayer HealthCare Pharmaceuticals Inc.
- Approved
- Jul 23, 1993
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for interferon beta-1b, in chronological order.
Reference approval
Approval date of the reference interferon beta-1b product.
33 yr 4 mo ago
Frequently asked questions
Are there biosimilars approved for interferon beta-1b (Betaseron)?
No 351(k) biosimilars or interchangeable biosimilars referencing interferon beta-1b are listed in the FDA Purple Book yet.
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