FDA Purple Book · Reference family
aducanumab-avwa (Aduhelm)
aducanumab-avwa 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
2021
Reference approved
Reference product
351(a)BLA 761178
Aduhelm aducanumab-avwa
Biogen Inc.
- Approved
- Jun 07, 2021
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for aducanumab-avwa, in chronological order.
Reference approval
Approval date of the reference aducanumab-avwa product.
5 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for aducanumab-avwa (Aduhelm)?
No 351(k) biosimilars or interchangeable biosimilars referencing aducanumab-avwa are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.