Purple Book reference family · 351(a) biologic
pegunigalsidase alfa-iwxj (Elfabrio)
pegunigalsidase alfa-iwxj is an FDA-licensed reference biologic from Chiesi Farmaceutici S.p.A..
351(a) biologicBLA 761161 Chiesi Farmaceutici S.p.A.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2024
Reference product
Originator biologic
351(a)BLA 761161
Elfabrio pegunigalsidase alfa-iwxj
Chiesi Farmaceutici S.p.A.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference pegunigalsidase alfa-iwxj product.
2 yr 3 mo ago
pegunigalsidase alfa-iwxj: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for pegunigalsidase alfa-iwxj.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
