Xbrane Biopharma AB has received FDA approval for Lucamzi (ranibizumab-blrz), a biosimilar to Genentech’s Lucentis (ranibizumab injection).
First up, a refresh on Xbrane.
Operating out of Hagastaden, Stockholm, the commercial-stage company is a biosimilar developer in the ophthalmic (retina) and oncology / hematology spaces for global markets (including the U.S.).
- Take a look at its current pipeline.
The basis behind its biosimilars: LEMO (LEss is MOre), a patented platform technology designed to offer "significantly higher yields” and lower production costs.
Specifically, this tech is based on the production of proteins in E. coli cells. Click here for a deeper dive.
Next, a quick recap on biosimilars.
A few key differences distinguish biosimilars from generics:
While generics are designed as exact chemical copies of their reference biologics (name-brand drug counterpart), biosimilars are highly similar (but not identical) versions of their reference biologics.
- Notably: These drugs are allowed to have minor differences, just as long as they don’t result in clinically meaningful differences in the resulting safety and efficacy.
Now to the biosimilar in question—what do we know?
Lucamzi (ranibizumab-blrz) is an interchangeable biosimilar to Lucentis, a vascular endothelial growth factor (VEGF) inhibitor that initially received U.S. regulatory clearance in 2006.
In Lucamizi’s case: It’s already commercially available in Europe (since 2023) under the name Ximluci.
As for its FDA approval: This follows an initial Biologics License Application (BLA) submission to the FDA in April 2023, two complete response letters, and a resubmission in April 2026.
So what clinical data supported approval?
Per Xbrane, two sets of clinical evidence from:
- a comprehensive comparative analytical assessment at a structural and functional level
- a phase 3 clinical study (XPLORE; NCT03805100) in which Lucamzi demonstrated “equivalent efficacy and comparable safety to the reference product in 582 patients” with wet AMD
- Check out its 12-month topline data readout
And this isn’t the first Lucentis biosimilar to receive approval, right?
Indeed not. In fact, this marks the fourth ranibizumab biosimilar to receive FDA approval—and third in less than 12 months. See below for its predecessors:
- August 2022: Formycon AG’s FYB2-1/CIMERLI
- December 2025: Formycon and Bioeq’s Nufymco (ranibizumab-leyk)
- June 2026: Lupin Limited’s Ranuspec (ranibizumab-hkdz)
Noted. So what are its indications?
While the company didn’t provide the drug’s official prescribing information (PI), it’s safe to say the biosimilar is approved for the same five indications as its reference biologic:
- Wet age-related macular degeneration (AMD)
- Diabetic macular edema (DME)
- Diabetic retinopathy (DR)
- Macular edema due to retinal vein occlusion (RVO)
- Myopic choroidal neovascularization (mCNV)
And the dosing requirements?
For that, we’ll also refer to Lucentis’s PI.
Per that, the therapeutic is packaged in a single-dose prefilled syringe and is intended for administered via an intravitreal (IVT) injection.
The dosages (per indication):
- Wet AMD: 0.5 mg (0.05 mL of 10 mg/mL solution)
- Frequency: Once a month (approximately 28 days)
- To note: Though not as effective, patients may also be treated with:
- 3 monthly doses followed by less frequent dosing with regular assessment
- 1 dose every 3 months after 4 monthly doses with regular assessment
- To note: Though not as effective, patients may also be treated with:
- Frequency: Once a month (approximately 28 days)
- Macular edema due to RVO: 0.5 mg (0.05 mL of 10 mg/mL solution)
- Frequency: Once a month (approximately 28 days)
- DME and DR: 0.3 mg (0.05 mL of 6 mg/mL solution)
- Frequency: Once a month (approximately 28 days)
- mCNV: 0.5 mg (0.05 mL of 10 mg/mL solution)
- Frequency: Initially administered once a month (approximately 28 days) for up to 3 months
- To note: Patients may be re-treated if needed
- Frequency: Initially administered once a month (approximately 28 days) for up to 3 months
Any contraindications or other precautions to be aware of?
Lucentis’s PI (see Section 4.1) notes that the IVT injection is contraindicated in patients with:
- Ocular or periocular infections
- Hypersensitivity to ranibizumab or any of the excipients in the drug
- Reactions may develop as severe intraocular inflammation (IOI)
As for warnings or precautions: endophthalmitis, retinal detachments, and intraocular pressure (IOP) increases are among the potential occurrences. See Section 5 of the PI for more details.
Any other adverse reactions?
Serious adverse reactions related to the injection procedure were noted as occurring in <0.1% of IVT injections evaluated in clinical trials used to support the name-brand drug’s approval (see Section 6 of the PI).
- Among these: endophthalmitis (as listed earlier), rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.
- Refer to that same section for more reported ocular reactions.
Noted. So when is Lumazi expected to launch?
Xbrane is currently finalizing preparations for a 2027 U.S. commercial launch in partnership with Valorum Biologics.
Per an exclusive commercial licensing agreement, Valorum will be responsible for sales, marketing and all other commercialization efforts.