UK Authorizes New Lucentis Biosimilar, Ximluci

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted marketing authorization for Ximluci, a ranibizumab biosimilar developed as part of a partnership between STADA Arzneimittel and Xbrane Biopharma.

The approval marks the second ranibizumab biosimilar for the UK market, following the approval of Teva Pharmaceuticals’ Ongavia in May 2022.

Ranibizumab products are vascular endothelial growth factor inhibitors used for the treatment of retinal diseases, such as neovascular age-related macular degeneration (AMD), macular edema, diabetic retinopathy, retinal vein occlusion, and visual impairment due to choroidal neovascularization in adults. Ximluci was approved for all indications of the reference products.

“Considerable unmet need for biologic ophthalmic treatments exists in the UK and throughout Europe…. With almost 15 years’ experience of supplying biosimilars, STADA looks forward to working with Xbrane, as well as with the [National Health Service] and our commercial partners, to broaden patient access to ranibizumab and optimize use of healthcare resources in the UK,” commented Bryan Kim, MBA, head of specialty care at STADA Arzneimittel.

According to the Macular Society, nearly 1.5 million people in the United Kingdom have macular disease and it affects people of all ages, especially people older than 55 years. AMD is the most common cause of vision loss in the United Kingdom and impacts more than 600,000 people.

“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 expression system in Europe,” said Martin Åmark, MSc, MBA, CEO of Xbrane Biopharma.

The approval for Ximluci was granted through the European Commission (EC) Decision Reliance Procedure, whereby the MHRA’s decision was based on the one made by the EC. The EC granted marketing authorization to Ximluci in November 2022, making it available for patients in all 27 European Union member states, Iceland, Norway, and Liechtenstein. The EC came to its decision after reviewing data establishing Ximluci’s biosimilarity to the refence product. Ximluci was the third ranibizumab biosimilar to be approved in the European Union, following the approvals for Byooviz and Ranivisio.

STADA Arzneimittel and Xbrane Biopharma entered into a licensing agreement in July 2018, in which both companies share development and manufacturing responsibilities. STADA Arzneimittel, a Bad Vilbel, Germany–based company, holds the marketing authorizations and commercial rights for the biosimilars included in the deal across all territories, including Europe, the United States, and several countries in the Middle East and North Africa, as well as markets in the Asia-Pacific region.