Ranluspec (ranibizumab-hkdz)
Biosimilar
- Region
- 🇺🇸 US
- Active substance
- ranibizumab-hkdz
- Company
- Lupin Limited
- Status
- Approved
- FDA approval
- Tue 02 Jun 2026
- Designations
- Biosimilar
- Application
- BLA761480
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Tue 02 Jun 2026🇺🇸 FDA approval
FDA approves biosimilar Ranluspec (ranibizumab-hkdz)
Lupin Limited; BLA761480; Biosimilar; injection · source
Tue 10 Feb 2026🇪🇺 EU approval (EC decision)
Ranluspec (ranibizumab) approved in the EU
Marketing authorisation to Lupin Europe GmbH; Biosimilar, Additional monitoring · source
Thu 11 Dec 2025🇪🇺 CHMP positive opinion
Ranluspec (ranibizumab): CHMP positive opinion
Lupin Europe GmbH; Biosimilar, Additional monitoring · source
Follow Ranluspec
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.