MHRA approves biosimilar for vision disorders in Great Britain
Posted: 17 January 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
A marketing authorization for Ximluci® biosimilar referencing Lucentis® (ranibizumab) in Great Britain has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally.
Ximluci® has been approved in the UK for treating wet age-related macular degeneration (wet AMD), diabetic macular oedema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) in adults.
A biosimilar for biologic ophthalmic treatments
The European Medicines Agency (EMA) determined Ximluci® to be highly similar to the reference product, Lucentis®, based on data showing comparable quality, safety and efficacy to Lucentis®.
Ximluci® is an anti-VEGF (vascular endothelial growth factor) retinal vascular disorders. The British marketing authorisation for Ximluci® 10mg/ml solution for injection is held by STADA’s Genus Pharmaceuticals subsidiary. “Considerable unmet need for biologic ophthalmic treatments exists in the UK and throughout Europe,” commented Bryan Kim, STADA’s Head of Specialty Care.
The British marketing authorisation was granted via the European Commission (EC) Decision Reliance Procedure (ECDRP). The MHRA relied on the decision taken by the EC in November 2022 to issue a centralised marketing authorisation for Ximluci® valid in all 27 European Union member states, as well as in Iceland, Norway and Liechtenstein.
Manufacture and development of Ximluci®
“We are proud to have worked with STADA to take this molecule from cell-line development to approval and manufacturing, based on our patented expression system, in Europe,” stated Martin Åmark, CEO of Xbrane.
In July 2018, STADA and Xbrane entered into an agreement under which the two companies are jointly responsible for development and manufacturing of the finished product.
The marketing authorisations and commercial rights to the biosimilar are held by STADA across all territories included in the agreement. It covers Europe, the US, several countries in the Middle East and North Africa (MENA) region, and selected Asia-Pacific (APAC) markets.
STADA is preparing to launch Ximluci® in the UK during 2023.
▼Ximluci® 10mg/ml solution for injection is subject to additional monitoring.