Ranluspec becomes the only interchangeable ranibizumab biosimilar in the US available in both vial and pre-filled syringe formats

In a significant boost to its global biosimilars portfolio, Lupin Limited has received approval from the United States Food and Drug Administration (US FDA) for its biosimilar ranibizumab, marketed as Ranluspec™ (ranibizumab-hkdz). The drug has been approved as an interchangeable biosimilar to Lucentis, a widely used treatment for several serious retinal and vision-threatening disorders.

The approval marks an important milestone for the Mumbai-headquartered pharmaceutical major, strengthening its position in the rapidly growing biologics and biosimilars segment.

Ranluspec has achieved a unique distinction in the United States market by becoming the only interchangeable ranibizumab biosimilar approved in both vial and pre-filled syringe (PFS) presentations. Both formats have been cleared in the two strengths available for Lucentis — 0.3 mg and 0.5 mg — offering greater flexibility and convenience for healthcare providers and patients.

Ranibizumab is a recombinant humanized monoclonal antibody fragment designed to block vascular endothelial growth factor A (VEGF-A), a protein that contributes to abnormal blood vessel growth in the eye. The therapy is used to treat a range of retinal diseases, including neovascular or wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Commenting on the development, Vinita Gupta, Chief Executive Officer of Lupin, said the approval adds significant depth to the company's biosimilars portfolio and reflects its growing expertise in complex biologic therapies.

She noted that the launch of the company's second biosimilar product in the US market represents another step forward in expanding patient access to proven vision therapies while strengthening Lupin's presence in the biologics space.

Nilesh Gupta, Managing Director of Lupin, said the approval underscores the company's scientific capabilities and advanced manufacturing expertise. He added that the achievement supports Lupin's strategy of building a scalable biosimilars business while making high-quality and affordable treatment options available to more patients.

Highlighting the scientific significance of the approval, Dr. Cyrus Karkaria said the US FDA's decision validates the company's strength in biologics research, development, and manufacturing. According to him, the milestone reinforces Lupin's commitment to improving global access to advanced and cost-effective therapies.

The approval is expected to enhance competition in the US ophthalmology market while offering patients and healthcare systems a more affordable alternative to branded biologic treatments. Industry experts view the development as another indication of Indian pharmaceutical companies' growing role in the global biosimilars landscape, particularly in highly regulated markets such as the United States.