The European Union Gains Another Ranibizumab Biosimilar

The European Commission granted marketing authorization for Ximluci, the third ranibizumab biosimilar to be approved in the European Union. The product was developed through a partnership between STADA Arzneimittel and Xbrane Biopharma and is expected to launch in early 2023.

The biosimilar references Lucentis (ranibizumab) and was approved to treat neovascular age-related macular degeneration (wet AMD), diabetic macular edema, diabetic retinopathy, retinal vein occlusion, and visual impairment due to choroidal neovascularization in adults. According to STADA and Xbrane, wet AMD affects about 7 million people across Europe and an estimated 500,000 new patients receive the diagnosis each year.

STADA and Xbrane entered into a partnership in July 2018, under which the companies are “jointly responsible for development and for manufacturing” the products contained within the agreement. STADA holds the marketing authorization and commercialization rights for Ximluci in the European Union, United States, several countries in the Middle East and North Africa region, and certain Asia-Pacific markets.

“We are proud to have worked with STADA to take this molecule, developed under the Xlucane name, from cell-line development to approval and manufacturing via our patented expression system in Europe…. Clinicians can prescribe Ximluci with confidence of producing comparable clinical outcomes to the reference product, Lucentis, based on extensive comparative quality studies and clinical data,” commented Martin Åmark, CEO of Xbrane.

Ximluci is the fifth biosimilar developed by STADA’s Specialty Care portfolio to be approved in Europe, following the approvals of Hukyndra (adalimumab biosimilar), Oyavas (bevacizumab biosimilar), Silapo (epoetin zeta biosimilar), and Movymia (teriparatide biosimilar). The marketing authorization application for the company’s pegfilgrastim biosimilar (Cavoley) was withdrawn in February 2019 because STADA could not address concerns raised by the Committee of Medicinal Products for Human Use by a given date.

“Having already successfully launched 5 biosimilars… we are excited to take our rapidly expanding Specialty Care portfolio into an important and growing therapeutic category—ophthalmology. This product authorized through STADA’s strategic partnership with Xbrane will help to increase patient access to biological treatments and optimize use of health care resources,” said Peter Goldschmidt, CEO of STADA, in a statement.

Prior to the approval of Ximluci, Byooviz was approved in August 2021 and Ranivisio was approved in August 2022. Byooviz was also approved in the United States in September 2021 and in Canada in March 2022. In August 2022, the FDA approved Cimerli, the first interchangeable ranibizumab biosimilar. A large portion of the anti-vascular endothelial growth factor market, which accumulated about €4 billion in 2021 and has grown by 8% annually between 2019 and 2021, comprises sales for ranibizumab products and aflibercept products.