The FDA has approved ranibizumab-hkdz (Ranluspec; Lupin Limited), a biosimilar referencing ranibizumab (Lucentis; Genentech), developed by Lupin Limited. Notably, ranibizumab-hkdz carries an interchangeable biosimilar designation and is the only FDA-approved ranibizumab biosimilar available in both vial and prefilled syringe (PFS) presentations—a distinction that may carry practical implications for ophthalmology practices managing high-volume intravitreal injection programs.
"The U.S. FDA approval of our biosimilar ranibizumab underscores our scientific expertise in biologics development and manufacturing, and reinforces our commitment to expanding access to advanced, affordable therapies for patients worldwide," said Cyrus Karkaria, PhD, president of Biotechnology at Lupin in a press release.4
Approval scope and formulation details
Ranibizumab-hkdz is approved in both strengths that match those of the reference product: .3 mg (.05 mL of 6 mg/mL) and .5 mg (.05 mL of 10 mg/mL). Both concentrations are available in vials and PFS formats. The interchangeable designation, as defined under the Biologics Price Competition and Innovation Act (BPCIA), means that pharmacists may, subject to applicable state law, substitute ranibizumab-hkdz for ranibizumab without intervention by the prescribing physician—a regulatory distinction that goes beyond standard biosimilar approval and may facilitate uptake across retinal practices and health systems.¹
The approved indications mirror those of Lucentis and include neovascular wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).
Clinical context and disease burden
Ranibizumab-hkdz targets VEGF-A, a key mediator of ocular neovascularization and vascular permeability, through a recombinant humanized IgG1 monoclonal antibody fragment mechanism. Since its original FDA approval in 2006, the reference product has become a foundational therapy across multiple retinal and choroidal vascular conditions.¹ Wet AMD alone affects an estimated 1.7 million Americans, with that number projected to grow substantially as the population ages.² The broader set of indications covered under ranibizumab-hkdz's approval—including DME and DR—represents a significant share of retinal practice volume.
Despite established clinical efficacy, real-world utilization of anti-VEGF therapy has been constrained by cost, with treatment burden and affordability cited as barriers to optimal adherence and outcomes.³ Biosimilar entry into the anti-VEGF space has been viewed as one potential mechanism to expand access, particularly in underserved populations.
KEY FACTS
• Drug: ranibizumab-hkdz (Ranluspec; Lupin Limited)
• Class: Anti-VEGF biosimilar; IgG1 Fab fragment
• Reference product: ranibizumab (Lucentis; Genentech)
• Regulatory action: FDA approval; interchangeable biosimilar
• Indications: Wet AMD, RVO-ME, DME, DR, mCNV
• Formulations: .3 mg and .5 mg; vials and PFS
• Interchangeable status: Yes—first ranibizumab biosimilar with this designation in both formats
• Key safety signals: Not separately reported; consistent with reference product class
• Geography: United States
Biosimilar landscape for ranibizumab
Ranibizumab-hkdz is not the first biosimilar ranibizumab to reach the US market; several biosimilar ranibizumab products have previously received FDA approval. However, according to Lupin, ranibizumab-hkdz is the first to receive both interchangeable status and approval in the dual-format presentation of vials and PFS across both available strengths. The interchangeable designation requires demonstration of biosimilarity plus evidence that the product can be expected to produce the same clinical result as the reference product in any given patient. For products administered more than once, that switching or alternating between the biosimilar and reference product poses no greater risk than continuous use of the reference product.¹
This regulatory standard is more rigorous than standard biosimilar approval and may influence formulary positioning and payer coverage decisions.
Drug background
Ranibizumab is a VEGF-A inhibitor delivered via intravitreal injection. Its mechanism involves binding to and neutralizing all active isoforms of VEGF-A, reducing pathological neovascularization and vascular leakage. As a Fab fragment rather than a full monoclonal antibody, it was originally designed to facilitate ocular penetration while limiting systemic exposure. The reference product, ranibizumab, was first approved by the FDA in 2006 for wet AMD and subsequently received supplemental approvals across its current label indications.¹
Ranibizumab-hkdz represents Lupin's second US biosimilar approval, according to the company, reflecting a broader strategic expansion into complex biologics manufacturing.
Interpretive considerations
The interchangeable designation may be clinically meaningful, but it is important to note that biosimilar interchangeability is primarily a regulatory and pharmacy-practice construct, it does not imply therapeutic superiority over other approved ranibizumab biosimilars, nor over alternative anti-VEGF agents such as aflibercept or faricimab. Prescribers should remain attentive to any evolving post-marketing data across the biosimilar ranibizumab class as real-world utilization expands.
Limitations and next steps
The press release does not disclose the specific clinical or analytical studies submitted in support of the interchangeable designation, and peer-reviewed data characterizing the biosimilarity package for ranibizumab-hkdz were not available at the time of this report. Commercial availability and pricing have not been announced. Ophthalmologists should monitor formulary updates and state-level pharmacy substitution laws, which govern whether and how interchangeable substitution occurs in 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.
2. Congdon N, O'Colmain B, Klaver CC, Klein R, Muñoz B, Friedman DS, Kempen J, Taylor HR, Mitchell P; Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):477-85. doi:10.1001/archopht.122.4.477.
3. Soares RR, Mellen P, Garrigan H, Obeid A, Wibbelsman TD, Borkar D, Ho AC, Hsu J. Outcomes of Eyes Lost to Follow-up with Neovascular Age-Related Macular Degeneration Receiving Intravitreal Anti-Vascular Endothelial Growth Factor. Ophthalmol Retina. 2020 Feb;4(2):134-140. doi:10.1016/j.oret.2019.07.010.
4. Lupin Limited. Lupin receives approval from U.S. FDA for Ranluspec (ranibizumab) injection. PR Newswire. June 4, 2026. https://www.prnewswire.com/news-releases/lupin-receives-approval-from-us-fda-for-ranluspecranibizumab-injection-302792038.html
