FDA Clears Lucentis Biosimilar for Wet AMD

A Lucentis biosimilar gains approval for wet AMD, with a planned U.S. launch in 2027 after a European rollout.

Updated on Nov. 3, 2026 in Biotech

Screen-print poster illustration of a single plain glass vial and fine needle on a pale field, suggesting a biosimilar drug approval. — The FDA approved Lucamzi, a ranibizumab biosimilar to Genentech's Lucentis for wet macular degeneration, with a U.S. launch planned for 2027. AI Illustration. Upload story photo >

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The FDA approved Lucamzi (ranibizumab-blrz), a biosimilar to Genentech's Lucentis, for neovascular age-related macular degeneration and other serious eye conditions. Xbrane Biopharma plans a U.S. launch in 2027. The approval is a regulatory milestone; the product is not yet commercially available in the United States.

Why it matters

Biosimilars are lower-cost versions of established biologic drugs, and approval of a ranibizumab biosimilar adds competition to a therapy used to treat AMD. The same molecule has been marketed in Europe as Ximluci since 2023, giving the approval a track record outside the U.S. market.

The approval rests on a phase 3 trial of 582 patients with wet AMD, which found the biosimilar equivalent to Lucentis in effectiveness and comparable in safety. Ranibizumab is dosed as a 0.5 mg/0.05 mL single-dose vial injected into the eye. Long-term outcomes beyond the trial window were not reported in the source.

The players

Xbrane Biopharma

A biopharmaceutical company developing biosimilar versions of established biologic medicines, and the company planning the U.S. launch of Lucamzi.

Genentech

The Roche subsidiary that manufactures Lucentis, the reference ranibizumab product that Lucamzi is designed to match.

The details

Ranibizumab is an anti-VEGF therapy, a class of drugs that blocks vascular endothelial growth factor, a protein that drives abnormal blood vessel growth in the retina. A biosimilar is a biologic drug shown to be highly similar to an already-approved reference product, so it can be approved through a shorter pathway than a new drug. The drug is delivered as a direct injection into the eye, and the most common side effects include conjunctival hemorrhage, eye pain, vitreous floaters, and temporarily increased intraocular pressure.

Since 2023: the biosimilar has been available in Europe as Ximluci.
November 3, 2026: the FDA approval was reported.
2027: Xbrane plans to launch Lucamzi in the United States.

The Tech Race

Lucamzi is a biosimilar version of Lucentis, the Genentech anti-VEGF therapy that has been a standard treatment for wet AMD. Its approval adds a lower-cost competitor to the ranibizumab market, following the same biosimilar pathway used for other biologics.

Patients with wet AMD in the United States will have access to Lucamzi starting in 2027, per the planned launch. Until then, the availability and pricing of the biosimilar relative to Lucentis have not been announced.

The takeaway

Watch for Xbrane's U.S. pricing and launch announcement ahead of the planned 2027 release. The timing and terms will determine how much the biosimilar changes access for the roughly 20 million Americans living with AMD.