Lupin and Sandoz sign licensing deal for biosimilar ranibizumab across multiple regions

(Image Credit: AdobeStock/Tohamina)

Lupin and Sandoz Group AG have entered into an agreement where Sandoz will market and commercialize Lupin’s biosimilar ranibizumab across multiple regions.

Sandoz will oversee commercialization of the product across the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia under the terms of the agreement. While Sandoz will oversee the commercialization, Lupin will be responsible for manufacturing the product and for regulatory submissions.

In all areas excluding France, Australia, Vietnam, and Malaysia, Sandoz will hold exclusive marketing rights. In France, Australia, Vietnam, and Malaysia, the company will have semi-exclusive marketing rights.

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). It is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), and choroidal neovascularization (CNV).

Thierry Volle, president EMEA and emerging markets at Lupin, commented on the partnership in a press release.

“We are delighted to partner with Sandoz for the launch and commercialization of ranibizumab in multiple markets globally. This partnership underscores our shared vision to expand global access to cutting-edge biologic therapies and improve outcomes for underserved patients.”

Another agreement between the companies will grant Sandoz sole rights for commercialization of Lupin’s biosimilar ranibizumab in Canada, while Lupin will manage its manufacture and regulatory filings.

Last summer, Lupin successfully completed a global, phase 3 clinical study of its ranibizumab biosimilar, referring to the product as LUBT010 in a news release. No working name was used for the ranibizumab biosimilar in the August 2025 announcement of the Sandoz partnership. Since 2022, Lupin has been marketing its ranibizumab biosimilar in India under the brand name RaniEyes.²

References:

1. Lupin Announces Licensing Deal for Ranibizumab Biosimilar. Published August 12, 2025. Accessed August 12, 2025. https://www.lupin.com/lupin-announces-licensing-deal-for-ranibizumab-biosimilar/

2. Crago S. Lupin announces successful completion of phase 3 trials for LUBT010. Ophthalmology Times. Published August 7, 2024. Accessed August 12, 2025. https://www.ophthalmologytimes.com/view/lupin-announces-successful-completion-of-phase-3-trials-for-lubt010