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Ranluspec
ranibizumab-hkdz
351(k) Interchangeable Pharmacy-substitutable
Overview
Source: Purple BookProprietary name
Ranluspec
Proper name
ranibizumab-hkdz
Licence type
351(k) Interchangeable
BLA number
761480
Applicant
Lupin Limited (Biotech Division)
Center
CDER
Presentations
4
First licensure
—
351(k) biosimilar pathway. This product was licensed as highly
similar to a reference product, with no clinically meaningful differences in
safety, purity or potency.
It also carries the interchangeable designation, so a pharmacist may substitute it for the reference product without contacting the prescriber.
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10MG/ML (0.5MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Rx | June 2, 2026 |
| 10MG/ML (0.5MG/0.05ML) | Injection | Intravitreal | Pre-Filled Syringe | Rx | June 2, 2026 |
| 6MG/ML (0.3MG/0.05ML) | Injection | Intravitreal | Single-Dose Vial | Rx | June 2, 2026 |
| 6MG/ML (0.3MG/0.05ML) | Injection | Intravitreal | Pre-Filled Syringe | Rx | June 2, 2026 |
Reference product
Source: Purple BookThis product is licensed with reference to Lucentis (ranibizumab).
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |