Lupin partners with Sandoz Group AG to commercialise and market its biosimilar ranibizumab worldwide. The product will be commercialised in a number of markets, excluding Germany, by Sandoz, while Lupin will be responsible for manufacturing and regulatory submissions. The partnership underscores both companies’ commitment to expanding patients’ access to innovative biologic therapies.
Commercialisation in the European Union (with the exception of Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia will be undertaken by Sandoz. Sandoz has been given exclusive marketing rights in most of these areas but semi-exclusive marketing rights in France, Australia, Vietnam, and Malaysia.
Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that selectively binds to and inhibits vascular endothelial growth factor A (VEGF-A). It is indicated for a variety of ophthalmology-related treatments, such as neovascular (wet) age-related macular degeneration (AMD), macular edema caused by retinal vein occlusion (RVO), diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), and choroidal neovascularization (CNV).
Thierry Volle, president of EMEA and emerging markets at Lupin, emphasised the strategic importance of this partnership:
“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.”
Additionally, Lupin partners with Sandoz Group in a separate agreement which will enable Sandoz to hold sole commercialisation rights for Lupin’s biosimilar ranibizumab in Canada, while Lupin continues to manage manufacturing and regulatory filings.
Lupin’s ranibizumab biosimilar, referenced as LUBT010 during its global Phase 3 clinical trial earlier, has been marketed in India since 2022 under the brand name RaniEyes. No working name is being used for the ranibizumab biosimilar announced in partnership with the Sandoz group.
