Ranluspec FDA approval: Cyrus Karkaria, PhD, on biosimilar access, prefilled syringes, and long-term switching confidence

Following the FDA approval of ranibizumab-hkdz (Ranluspec; Lupin Limited) as an interchangeable biosimilar referencing ranibizumab (Lucentis; Genentech), Modern Retina spoke with Cyrus Karkaria, PhD, president of Biotech Business at Lupin, about what the approval means for retinal practices and patients. Karkaria is a postdoctoral fellow from Harvard Medical School with a PhD from the University of Maryland and has more than 3 decades of biologics experience at institutions including Biogen and Celldex Therapeutics.

Ranibizumab-hkdz received FDA approval with an interchangeable biosimilar designation—a regulatory distinction that allows pharmacists to substitute the biosimilar for the reference product, ranibizumab (Lucentis; Genentech), without prescriber intervention, subject to applicable state law. The approval covers 5 indications: neovascular wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. According to Lupin, ranibizumab-hkdz is the first ranibizumab biosimilar to carry both the interchangeable designation and dual-format availability across both approved strengths. In the following Q&A, Karkaria expands on the clinical and operational implications of the approval.¹

In the following Q&A, Karkaria discusses the efficiency and safety advantages of the prefilled syringe format in high-volume intravitreal injection settings, the role biosimilar pricing can play in expanding anti-VEGF access for underserved patients, and what post-marketing evidence will be needed to support long-term confidence in switching stable patients from the reference product.

This interview was lightly edited for style and clarity.

What does the availability of ranibizumab-hkdz in both vials and pre-filled syringes mean for high-volume intravitreal injection practices—does the prefilled syringe format offer any meaningful safety or efficiency advantages?

Cyrus Karkaria, PhD: In high-volume intravitreal procedures, maintaining consistency and efficiency of delivery is paramount. The availability of ranibizumab-hkdz in both vial and pre-filled syringe formats provides flexibility, but there is a clear preference in many settings for pre-filled syringes.

The pre-filled syringe format reduces preparation steps prior to administration, which helps streamline the workflow and minimize handling. In busy clinical environments, this can translate into improved procedural efficiency and adds a layer of safety by reducing the potential for variability during preparation.

Anti-VEGF therapy adherence has long been constrained by cost. Do you expect biosimilar entry at this level to meaningfully move the needle for underserved patient populations, or are there systemic barriers that biosimilar pricing alone cannot solve?

Karkaria: Anti-VEGF therapies are highly effective in treating diabetic retinopathy by reducing abnormal blood vessel growth and reducing retinal swelling (macular edema). Administered via intravitreal injections, they help stabilize or improve vision but usually require frequent or ongoing treatment.

Expanded availability of biosimilars has the potential to improve access to anti-VEGF therapies, particularly for underserved patient populations. Pricing is an important lever, as more affordable options can support better treatment continuity in conditions where adherence is critical to clinical outcomes.

At the same time, access is influenced by a broader set of factors—including patient awareness, diagnostic patterns, healthcare infrastructure, and reimbursement pathways. Biosimilars, therefore, form an important part of the solution, but their full impact is realized when complemented by improvements across the care ecosystem.

What post-marketing data would you want to see before feeling fully confident in long-term switching between ranibizumab-hkdz and the reference product, particularly in patients who have been stable on ranibizumab (Lucentis; Genentech) for years?

Karkaria: As an interchangeable biosimilar, ranibizumab-hkdz has met stringent regulatory standards for similarity in safety, efficacy, and immunogenicity. This provides a strong foundation for clinical use, including switching scenarios. These requirements are rigorous and designed to ensure that clinical outcomes remain consistent with the innovator / reference product.

From a post-marketing perspective, continued real-world evidence—particularly regarding long-term safety, immunogenicity, and treatment durability—will further strengthen confidence, especially among patients who have remained stable on the reference therapy over extended periods. More broadly, as experience with biosimilars continues to evolve, they are expected to play an important role in expanding access to high-quality, cost-effective therapies and in supporting treatment continuity while maintaining clinical confidence in routine practice.

References
1. US Food and Drug Administration. Biosimilar and interchangeable products. https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products. Accessed June 4, 2026.