Ranibizumab biosimilar is being launched in major European markets. Ranibizumab is the first product brought to market through a strategic collaboration between STADA and Xbrane Biopharma AB (Nasdaq Stockholm: XBRANE), marking Xbrane's first commercial launch and STADA's first co-development asset, in its growing biosimilars portfolio. Developed and manufactured solely in Europe, ranibizumab is the sixth biosimilar marketed in Europe by STADA, and the first to treat ophthalmologic conditions.

For the estimated 400,000 people per year in the European Union (EU) who develop age-related macular degeneration (AMD) every year, their impairment to sight can have a substantial impact on their quality of life and emotional wellbeing. Whether it's enjoying the latest film in a cinema or finding one's car keys, life can be difficult with AMD. Indeed, AMD is the main cause of severe visual impairment and blindness in Europe, generating an estimated treatment cost of 2.4 billion per year.

With the introduction of ranibizumab in several European countries, partners STADA Arzneimittel AG and Xbrane Biopharma AB are offering European patients a cost-effective option to treat visual impairment in all the adult indications of the reference biologic. Shipments of the ranibizumab biosimilar, which is produced, filled, sterilized, and packaged entirely within Europe, have begun, and launch activities are underway. 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.

Ranibizumab is the sixth biosimilar launched within STADA's Specialty Care portfolio joining epoetin zeta, pegfilgrastim, teriparatide, bevacizumab and adalimumab and the first product developed through a strategic collaboration between STADA and Xbrane. Under this agreement, begun in July 2018, the partners are jointly responsible for development and for manufacturing the finished product, while STADA holds the marketing authorizations and commercial rights. As with the reference biologic, the ranibizumab biosimilar is supplied as a 2.3mg/0.23ml single-use vial for injection for intravitreal use.

The vascular endothelial growth factor (VEGF) inhibitor has been approved in European Union, as well as in the UK, for the treatment of wet 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 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.