FDA Approves Lupin’s Interchangeable Ranibizumab Biosimilar Ranluspec for Multiple Retinal Diseases

The FDA has approved Lupin’s ranibizumab-hkdz (brand name Ranluspec), an interchangeable biosimilar referencing ranibizumab (Lucentis), expanding treatment options for patients with several retinal diseases, according to a June 4 company announcement.¹

Ranluspec is approved for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.¹

The approval marks Lupin’s second biosimilar product in the US and adds to the company’s growing biologics portfolio.¹

What makes Ranluspec distinct among ranibizumab biosimilars?

According to Lupin, Ranluspec is the only interchangeable ranibizumab biosimilar approved in the US in both vial and pre-filled syringe presentations.¹

The biosimilar is available in the same strengths as the reference product, including 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL).¹

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A), a signaling protein involved in abnormal blood vessel growth and leakage associated with retinal disease.¹

Why is interchangeability important?

Interchangeability is a regulatory designation that allows a biosimilar to be substituted for its reference product at the pharmacy level, subject to state pharmacy laws. The FDA notes that interchangeable biosimilars meet the same standards of safety, purity, and potency as their reference biologics and can help expand patient access to biologic medicines.²

FDA officials have emphasized that both biosimilars and interchangeable biosimilars are expected to provide the same clinical outcomes as their reference products, with no clinically meaningful differences in safety or effectiveness.²,³

For ophthalmology practices and healthcare systems, interchangeable products may simplify adoption by providing greater flexibility in product selection while supporting efforts to manage treatment costs for chronic retinal diseases that often require ongoing injections.²

How does the approval support Lupin’s biosimilars strategy?

Lupin executives described the approval as an important step in the company’s efforts to expand its biosimilars business and improve patient access to biologic therapies.

“As our second U.S. biosimilar, Ranibizumab adds depth to our biosimilars portfolio, reflecting our progress in complex biologics while expanding patient access to proven vision therapies,” said Vinita Gupta, CEO of Lupin, in the company announcement.¹

Nilesh Gupta, managing director of Lupin, stated that the approval highlights the company’s scientific and manufacturing capabilities while supporting development of a scalable biosimilars portfolio.¹

Dr. Cyrus Karkaria, president of biotechnology at Lupin, added that the approval demonstrates the company’s expertise in biologics development and manufacturing and supports its goal of increasing global access to advanced therapies.¹

What does the approval mean for the ophthalmology biosimilars market?

The market for anti-VEGF therapies has become an increasingly active area for biosimilar competition. Ranibizumab has long been a standard treatment option for wet AMD and other retinal disorders, prompting multiple manufacturers to pursue biosimilar versions as patents expired. In recent years, the FDA has approved several ranibizumab biosimilars, reflecting growing competition in the ophthalmology sector.²

Industry stakeholders view biosimilars as a means of improving access to biologic therapies while potentially reducing healthcare expenditures. According to the FDA, biosimilars increase the number of available treatment options and may contribute to lower costs through increased market competition.²

The addition of another interchangeable ranibizumab product may provide physicians, payers, and patients with greater choice in managing chronic retinal diseases, particularly as demand for anti-VEGF therapies continues to grow.

Lupin, headquartered in Mumbai, India, markets pharmaceutical products in more than 100 countries and maintains a portfolio spanning branded medicines, generics, complex generics, biotechnology products, and active pharmaceutical ingredients.¹

References

1. Lupin Receives Approval from U.S. FDA for Ranluspec™(ranibizumab) Injection. (2026 Jun 4). PR Newswire. https://prnmedia.prnewswire.com/news-releases/lupin-receives-approval-from-us-fda-for-ranluspecranibizumab-injection-302792038.html
2. Biosimilar Product Information. (2026). FDA. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information?utm_source=chatgpt.com
3. FDA. 9 Things to Know About Biosimilars and Interchangeable Biosimilars. Updated 2026. Accessed June 5, 2026.