Ximluci, a Lucentis Biosimilar, Launches in Europe

Partners STADA Arzneimittel and Xbrane Biopharma have launched Ximluci, a ranibizumab biosimilar, in several European countries for the treatment of several ophthalmic conditions.

“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, based on our patented protein-expression system. Commercialization of our first biosimilar in Europe marks a major milestone in the evolution of our company,” Martin Åmark, CEO of Xbrane, said in a statement.

The biosimilar was the third product referencing Lucentis (reference ranibizumab) to be approved in the European Union (November 2022). Ximluci was also the third ophthalmology biosimilar overall to be granted marketing authorization in Europe. In addition to STADA and Xbrane’s product, the European Medicines Agency has approved Byooviz (August 2021) and Ranivisio (August 2022). In September 2022, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency approved Ximluci.

Ranibizumab products are used in the treatment of neovascular age-related macular degeneration (wet AMD), diabetic macular edema, diabetic retinopathy, myopic choroidal neovascularization, and macular edema following retinal vein occlusion. Ximluci is supplied as a 2.3 mg/0.23 mL single-use vial for injection for intravitreal use.

An estimated 400,000 people in the European Union are diagnosed with AMD every year, which can substantially affect patients’ quality of life and emotional well-being. AMD is the main cause of severe visual impairment and blindness in Europe, resulting in about €2.4 billion in treatment costs annually.

In addition to Ximluci, STADA has 5 other biosimilars across immunology, oncology, and bone health:

• Silapo (epoetin zeta)
• Cegfila (pegfilgrastim)
• Movymia (teriparatide)
• Oyavas (bevacizumab)
• Hukyndra (adalimumab)

“Having already successfully launched five biosimilars we are delighted to be making our Ximluci ranibizumab product available to ophthalmologists and their patients. This European-made biosimilar, developed through STADA’s strategic partnership with Xbrane, will help to increase patient access to biological treatments and foster competition that contributes to the sustainability of healthcare systems throughout Europe,” Peter Goldschmidt, CEO of STADA, commented in a statement.

Ximluci is the first product developed under the partnership between STADA and Xbrane. The companies entered into a strategic partnership in July 2018. Under the agreement, both companies are responsible for the development and manufacturing of the biosimilars. However, STADA will hold the marketing authorization and commercial rights to the biosimilar Europe and certain other international markets.

The EU marketing authorization was based on data from a comparative analytical assessment and a phase 3 clinical trial that demonstrated similar safety and efficacy profiles between the Ximluci and the reference product in patients with wet AMD. The study involved 580 patients and the primary end point was the change in best corrected visual acuity at week 8 from baseline. The study achieved the primary end point as the adjusted treatment differences between the products were within the predefined equivalence margin.