Purple Book reference family · 351(a) biologic
garetosmab-grts (Pasatru)
garetosmab-grts is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc..
351(a) biologicBLA 761508 Regeneron Pharmaceuticals, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2026
Reference product
Originator biologic
351(a)BLA 761508
Pasatru garetosmab-grts
Regeneron Pharmaceuticals, Inc.
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 garetosmab-grts product.
2 mo ago
garetosmab-grts: 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 garetosmab-grts.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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