FDA Purple Book · Reference family
alglucosidase alfa (Lumizyme)
alglucosidase alfa is an FDA-licensed reference biologic from Genzyme Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2010
Reference approved
Reference product
351(a)BLA 125291
Lumizyme alglucosidase alfa
Genzyme Corporation
- Approved
- May 24, 2010
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for alglucosidase alfa, in chronological order.
Reference approval
Approval date of the reference alglucosidase alfa product.
16 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for alglucosidase alfa (Lumizyme)?
No 351(k) biosimilars or interchangeable biosimilars referencing alglucosidase alfa are listed in the FDA Purple Book yet.
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