FDA approves STADA and Xbrane Lucamzi ranibizumab biosimilar for retinal diseases
The FDA has approved Lucamzi, a ranibizumab biosimilar developed by Xbrane Biopharma and commercialised through STADA, expanding treatment competition in retinal diseases.
Lucamzi (ranibizumab-blrz) has received US FDA approval as a biosimilar to Lucentis for retinal conditions including neovascular age-related macular degeneration, adding another treatment option within the established ranibizumab market.
Confirmed in STADA's announcement dated 29 October 2026, the decision strengthens the companies' US ophthalmology portfolio and introduces an additional biosimilar competitor without representing the first US approval of a ranibizumab biosimilar.
Field | Content |
Article Type | Approvals |
Regulatory Authority | U.S. Food and Drug Administration |
Regulatory Decision | Biosimilar approval |
Approval Announcement Date | 29 October 2026 |
Product Name | Lucamzi |
Nonproprietary Name | Ranibizumab-blrz |
Reference Product | Lucentis |
Product Type | Ranibizumab biosimilar |
Developer | Xbrane Biopharma |
Commercial Partner | STADA |
Therapeutic Area | Ophthalmology; retinal diseases |
Approved Indication Highlight | Neovascular age-related macular degeneration |
Other Approved Indications | Full indication list not confirmed in supplied summary |
Geography | United States |
Administration | Intravitreal administration |
Regulatory Significance | Additional FDA-approved ranibizumab biosimilar; not the first US ranibizumab biosimilar |
Regulatory Date Clarification | Approval confirmed in STADA announcement dated 29 October 2026 after an earlier publication-date discrepancy |
Commercial Launch Date | Not confirmed in supplied summary |
Pricing | Not disclosed |
What Happened | The FDA approved Lucamzi as a biosimilar to Lucentis for retinal diseases including neovascular age-related macular degeneration. |
Why It Matters | The approval expands biosimilar competition in the US retinal disease treatment market and may increase treatment choice and pricing competition. |
Commercial Context | Xbrane developed the biosimilar and STADA participates in its US commercialisation arrangements. |
Key Takeaway | Lucamzi has received FDA approval as an additional ranibizumab biosimilar for retinal diseases. |
What to Watch | US commercial launch, pricing, reimbursement, ophthalmologist adoption, supply arrangements and market share. |
Primary Source | STADA |
Primary Source URL | https://www.stada.com/blog/posts/2026/october/fda-approves-lucamzi-biosimilar-to-lucentis |
Relevant Date | 29 October 2026 |
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