STADA and Xbrane launch Ximluci ranibizumab biosimilar in Europe

2023-04-03

上市批准临床3期临床结果生物类似药引进/卖出

BAD VILBEL, Germany; SOLNA, Sweden I April 3, 2023 I Partners STADA and Xbrane Biopharma AB (Nasdaq Stockholm: XBRANE) are introducing Ximluci® (ranibizumab) in several European countries to offer European ophthalmolgists and their patients a cost-effective option to treat visual impairment, including neovascular or wet AMD AMD. The biosimilar is authorized as offering comparable quality, safety and efficacy in all the adult indications of the Lucentis® reference biologic.

Shipments of Ximluci, which is produced, filled, sterilized and packaged entirely within Europe, have begun in several countries, and launch activities are underway in many others.

For the estimated 400,000 people per year in the European Union (EU) who develop age-related macular degeneration (AMD), their impairment to sight can have a substantial impact on their quality of life and emotional wellbeing. AMD is the main cause of severe visual impairment and blindness in Europe[1], generating an estimated treatment cost of €2.4 billion per year.

The advent of biosimilar competition in Europe’s ranibizumab market offers improved patient access through cost-effective biosimilars with comparable quality, safety and efficacy to the original reference biologic. Such competition has already generated considerable value for patients, physicians and healthcare systems in therapeutic areas including immunology and oncology. For example, biosimilar competition on filgrastim increased patient access in the European Union by 44%.

STADA has a diverse portfolio of biosimilars in Europe across therapeutic areas encompassing immunology, oncology and bone health, building on a corporate heritage spanning more than 125 years of supplying high-quality consumer healthcare and generic medicines.

Ximluci is the sixth biosimilar launched within STADA’s Specialty Care portfolio - joining Silapo (epoetin zeta), Cegfila (pegfilgrastim), Movymia (teriparatide), Oyavas (bevacizumab) and Hukyndra (adalimumab) - and the first product developed through a strategic collaboration struck between STADA and Xbrane in July 2018. Under this agreement, the partners are jointly responsible for development and for manufacturing the finished product, while STADA holds the marketing authorizations and the commercial rights to the biosimilar in Europe and selected other territories.

“Having already successfully launched five biosimilars,” commented STADA CEO Peter Goldschmidt, “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.”

“We are proud to have worked with STADA to take this molecule, developed under the XlucaneTM 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,” stated Martin Åmark, CEO of Xbrane.

As with the reference biologic, Ximluci is supplied as a 2.3mg/0.23ml single-use vial for injection for intravitreal use. The vascular endothelial growth factor (VEGF) inhibitor vascular endothelial growth factor (VEGF) inhibitor has been approved in European Union, as well as in the UK, for the treatment of wet AMD AMD, diabetic macular oedema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) in adults.

The EU marketing authorization for Ximluci was based on a comprehensive comparative analytical assessment and a Phase 3 clinical study that demonstrated equivalent efficacy and comparable safety to the reference product. The Phase 3 clinical study involved 580 patients with wet age-related macular degeneration. The primary endpoint of the study was the change in best corrected visual acuity (BCVA) at week 8 compared to the baseline. This was met, as the adjusted treatment differences between the two products were within the predefined equivalence margin[2].

About STADA Arzneimittel AG

STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2022, STADA achieved group sales of EUR 3,797.2 million and reported earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR 884.7 million. As of 31 December 2022, STADA employed 13,183 people worldwide.

About Xbrane

Xbrane Biopharma AB develops biological drugs based on a patented platform technology that provides significantly lower production costs compared to competing systems. Xbrane has a portfolio of biosimilar candidates targeting EUR 53 billion in estimated annual peak sales of the respective reference product. The lead candidate Ximluci® has recently been granted market authorization approval in Europe will be launched during the first quarter 2023. Xbrane’s head office is in Solna, just outside Stockholm. Xbrane is listed on Nasdaq Stockholm under the ticker XBRANE. For more information, visit www.xbrane.com

[1] Li JQ, et al. Br J Ophthal. 2020;104:1077–1084

[2] https://www.ema.europa.eu/en/medicines/human/EPAR/ximluci

SOURCE: Stada Arzneimittel