STADA and Xbrane Receive British Approval for Ximluci® (Ranibizumab)

STADA Arzneimittel AG and Xbrane Biopharma AB announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Ximluci® (ranibizumab), a biosimilar of Lucentis®. STADA plans to launch Ximluci in the United Kingdom in 2023.

Xbrane's contribution to the collaboration comprises a proprietary protein-expression system and a production facility in Europe, while STADA has extensive experience selling biosimilars and other specialty pharmaceuticals in the UK.

“Considerable unmet need for biologic ophthalmic treatments exists in the UK and throughout Europe,” commented Bryan Kim, STADA’s Head of Specialty Care. “With almost 15 years’ experience of supplying biosimilars, STADA looks forward to working with Xbrane, as well as with NHS and our commercial partners, to broaden patient access to ranibizumab and optimize use of healthcare resources in the UK.”

“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 expression system, in Europe,” stated Martin Åmark, CEO of Xbrane.

Ximluci® is an anti-VEGF (vascular endothelial growth factor) medication used to treat retinal vascular diseases, a primary cause of blindness globally. In the United Kingdom, Ximluci® has been approved to treat individuals with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO), and visual impairment owing to choroidal neovascularization (CNV).

According to the UK’s Macular Society, nearly 1.5 million people in the UK have macular disease. Age-related macular degeneration is the most common condition, generally affected people aged over 55. AMD is the biggest cause of sight loss in the UK, affecting more than 600,000 people. [1]

The British marketing authorization was granted via the EC Decision Reliance Procedure (ECDRP), whereby the MHRA relied on the decision taken by the European Commission (EC) on 9 November 2022 to issue a centralized marketing authorization for Ximluci® valid in all 27 European Union member states, as well as in Iceland, Norway and Liechtenstein[2]. The European Medicines Agency had determined Ximluci® to be highly similar to the reference product, Lucentis®, based on data showing comparable quality, safety and efficacy to Lucentis®.[3]

References

[1] Macular conditions - Macular Society
[2] STADA and Xbrane secure EU approval for Ximluci® | STADA; » STADA and Xbrane secure EU approval for Ximluci® (ranibizumab) biosimilar referencing Lucentis®
[3] Ximluci: European Medicines Agency (europa.eu)