STADA and Xbrane Receives the MHRA’s Approval for Ximluci (biosimilar, ranibizumab) to Treat Retinal Diseases
- The MHRA has granted marketing authorization for Ximluci, a biosimilar referencing Lucentis in Great Britain. Ximluci is expected to be available in the UK in 2023
- The approval for Ximluci was granted through the EC decision reliance procedure, whereby the MHRA’s decision was based on the EC
- Ximluci was approved in the UK for wet AMD, DME, diabetic retinopathy, RVO, and visual impairment due to choroidal neovascularization in adults. STADA and Xbrane collaborated in July 2018 for the development and manufacturing of the finished product where STADA holds the marketing authorizations and the commercial rights to the biosimilar across all EU, the US, multiple countries in the MENA region, and selected APAC markets
Ref: Xbrane | Image: STADA
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