FDA Approves Ranluspec as Interchangeable Biosimilar to Lucentis

The FDA has granted approval for Ranluspec, an interchangeable biosimilar designed to treat various vision-threatening retinal diseases. Developed by Lupin, this new treatment serves as a biosimilar reference to Lucentis.

Ranluspec (ranibizumab-hkdz) is a recombinant humanized IgG1 monoclonal antibody fragment. It functions by inhibiting VEGF, which is critical in managing several severe ocular conditions.

Approved Applications and Delivery

The medication is indicated for the treatment of wet age-related macular degeneration and diabetic retinopathy. It is also approved for myopic choroidal neovascularization, diabetic macular edema, and macular edema following retinal vein occlusion.

To ensure flexibility in clinical settings, the FDA approved Ranluspec for delivery in both a vial and a prefilled syringe. It is available in two distinct strengths: 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL).

Did You Know? Ranluspec is the second U.S. Biosimilar released by Lupin, reflecting the company’s expansion into complex biologics.

Expanding Patient Access to Therapy

The introduction of Ranluspec is intended to broaden the availability of proven vision therapies. Vinita Gupta, CEO of Lupin, stated that this approval adds depth to the company’s biosimilars portfolio.

The regulatory landscape for these treatments is evolving. Previously, the FDA approved Nufymco (ranibizumab-leyk, Formycon) as an interchangeable biosimilar to Lucentis in December 2025.

Expert Insight: Samantha Carter notes that the “interchangeable” status of a biosimilar is a critical distinction. This designation may streamline the way clinicians transition patients between the reference product and the biosimilar, potentially increasing the adoption of these therapies in treating retinal diseases.

Potential Future Implications

With multiple interchangeable biosimilars now entering the market, there may be an increase in competition for the reference drug, Lucentis. This shift could lead to a wider variety of treatment options for patients suffering from retinal diseases.

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Healthcare providers may likely evaluate the different delivery methods, such as the prefilled syringe versus the vial, to determine the most efficient administration for their specific patient populations.

Frequently Asked Questions

What conditions is Ranluspec approved to treat?
It is indicated for wet age-related macular degeneration, diabetic retinopathy, diabetic macular edema, myopic choroidal neovascularization, and macular edema following retinal vein occlusion.

In what forms is Ranluspec available?
The medication is approved for delivery in a vial and a prefilled syringe, available in strengths of 0.3 mg and 0.5 mg.

What is the reference product for Ranluspec?
Ranluspec is an interchangeable biosimilar referencing Lucentis.

How do you think the availability of interchangeable biosimilars will impact patient access to specialized healthcare?