Phase 3 Trial Begins of Xbrane Biopharma's Ranibizumab Biosimilar

Xbrane Biopharma, a Swedish biotechnology company, says it is starting its phase 3 trial of its ranibizumab biosimilar, referencing Lucentis, and also set sales targets for the treatment for patients with wet age-related macular degeneration (AMD).

Xbrane expects the first revenues from Xlucane sales during the first quarter 2022. Its co-development and commercialization partner is Stada Arzneimittel AG.

This is the first proposed biosimilar studied by Xbrane after it announced in September 2018 that the company was shifting its focus from generic drugs to biosimilars.

Xbrane’s target is to reach €350 (USD $392.65) million in annual net sales 3 years after the product’s launch. This renders approximately €100 (USD $112.15) million in annual license income for Xbrane, after deduction of production and sales related expenses and profit sharing with Stada.

The sales target is based on reaching a volume market share of 25% in Europe and the United States of the ranibizumab market at a price discount in line with recent biosimilar product launches. During 2018, the brand-name Lucentis’ global sales amounted to €3.5 (USD $3.93) billion.

Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy. Other companies working on ranibizumab biosimilars include Coherus BioSciences and Samsung Bioepis.

“We strongly believe in the commercial prospects of Xlucane. There is a great need for more cost-efficient products in the ophthalmic VEGF inhibitor market, and I am confident that Xlucane will be received positively by the ophthalmology community and patients,” Martin Åmark, Xbrane’s chief executive officer, said in a statement.

The Xplore trial is designed as a phase 3 trial to confirm biosimilarity of the proposed biosimilar to the reference product in terms of safety, efficacy, and immunogenicity. The study will look to enroll about 600 patients across 150 sites in 16 countries. The primary end point is defined as the change in visual acuity after 8 weeks of treatment. In order to measure this success, the confidence interval of the difference between the proposed biosimilar and the reference will need to fall within a predefined equivalence margin.

According to the American Macular Degeneration Foundation, the wet type of AMD accounts for 10% to 15% of AMD. Abnormal blood vessels, called choroidal neovascularization or CNV, grow under the retina and macula and then bleed and leak fluid. As the macula bulges or lifts up from its normally flat position, central vision is distorted or destroyed.