Purple Book reference family · 351(a) biologic
apitegromab-mstn (Isembyld)
apitegromab-mstn is an FDA-licensed reference biologic from Scholar Rock, Inc..
351(a) biologicBLA 761463 Scholar Rock, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2026
Reference product
Originator biologic
351(a)BLA 761463
Isembyld apitegromab-mstn
Scholar Rock, 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 apitegromab-mstn product.
29 d ago
apitegromab-mstn: 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 apitegromab-mstn.
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