The STADA and Xbrane co-developed Ximluci, ranibizumab biosimilar is to launch in Europe and will now also be available on the UK’s National Health Service (NHS). In addition, the partners have submitted their Biologics License Application (BLA) to the US Food and Drug Administration (FDA).
The European Commission granted marketing authorization for Ximluci, a biosimilar referencing Lucentis ranibizumab, in 2022 [1, 2]. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorization for Ximluci, in February 2023 [3]. Now, the ranibizumab biosimilar will be available as a 2.3 mg/0.23 mL single-use vial for injection for intravitreal use in these regions. The NHS supply contract runs from 1 April 2023 to 31 March 2024 and has a nominal total value of £70 million (€79 million), although this is dependent on factors such as the ability to capture share within the market segment.
Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor. It can be used to treat macular degeneration by inhibiting VEGF, which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision [4]. It is a monoclonal antibody drug and has been approved in the European Union and the UK, for the treatment of wet age-related macular degeneration (AMD), diabetic macular oedema (DME), diabetic retinopathy (PDR), retinal vein occlusion (RVO) and visual impairment due to choroidal neovascularization (CNV) in adults.
‘Supplying ranibizumab to the NHS represents a further opportunity for STADA to improve patient access through competition on specialty medicines, and thereby deliver on our purpose of Caring for People’s Health as a Trusted Partner’, commented STADA’s Global Head of Specialty, Bryan Kim.
STADA and Xbrane submitted their BLA to FDA and expect a decision regarding this in early 2024.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Australia and EU: Alvotech Humira and Stada Lucentis biosimilars approved [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 4]. Available from:
www.gabionline.net/biosimilars/news/australia-and-eu-alvotech-humira-and-stada-lucentis-biosimilars-approved
2. GaBI Online - Generics and Biosimilars Initiative. Progress for Lucentis (ranibizumab) biosimilars in Europe and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 4]. Available from:
www.gabionline.net/biosimilars/news/progress-for-lucentis-ranibizumab-biosimilars-in-europe-and-the-us
3. GaBI Online - Generics and Biosimilars Initiative. Ranibizumab biosimilar Ximluci and Amelivu to launch in the UK and South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 4]. Available from:
www.gabionline.net/biosimilars/news/ranibizumab-biosimilar-ximluci-and-amelivu-to-launch-in-the-uk-and-south-korea
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ranibizumab (gabionline.net) [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 May 4]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-ranibizumab
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