XIMLUCI® (ranibizumab)
XIMLUCI® (ranibizumab)
Our first ophthalmology biosimilar, ranibizumab is a biological medicine that is injected into the eye. XIMLUCI® is the ranibizumab biosimilar from STADA Thornton and Ross.1
XIMLUCI® is indicated for adult patients, treatment of: neovascular (wet) age-related macular degeneration (AMD); visual impairment due to diabetic macular oedema (DME); proliferative diabetic retinopathy (PDR); visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO); visual impairment due to choroidal neovascularisation (CNV).
Prescribing Information can be found here
XIMLUCI® (ranibizumab) HCP and Patient Support:
We understand that information to support you and your patients on their treatment journey is essential to their treatment success. We have developed a range of resources to support you and your patient through the injection process and help your patients understand more about their treatment.
Clinical Resource:
XIMLUCI® (ranibizumab) Clinical Pack
XIMLUCI® (ranibizumab) Preparation and Administration Video
XIMLUCI® (ranibizumab) Injector Guide
XIMLUCI® (ranibizumab) Patient Leaflet (DME)
XIMLUCI® (ranibizumab) Patient Leaflet (wAMD)
XIMLUCI® (ranibizumab) has been proven to be equivalent to the reference product2*
Primary endpoint: Change in best corrected visual acuity (BCVA) from baseline to Week 8†
During the XPLORE trial, in patients with wAMD XIMLUCI® showed:2
Equivalent efficacy2
During the XPLORE trial†, XIMLUCI® was proven to be equivalent to the reference product* at both Week 8 and Week 52, as defined by change in BCVA from baseline2‡
Equivalent pharmacokinetic profile2
Plasma concentrations of ranibizumab were similar between XIMLUCI® and reference* treatment groups at both Day 1 and Week 202
Equivalent safety profile2
During the XPLORE trial, the safety profile of both XIMLUCI® and the reference product* was consistently well-tolerated2
Equivalent immunogenicity profile2
During the XPLORE trial, incidence and frequency of ranibizumab ADAs were similar between XIMLUCI® and reference* treatment groups2
Randomized trial of biosimilar XSB-001 (XIMLUCI®) versus reference ranibizumab in patients with neovascular Age-Related Macular Degeneration (XPLORE)
Full details of the XPLORE Trial2 can be found here
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References
1. XIMLUCI® (ranibizumab) Summary of Product Characteristics. January 2023. Available at: https://www.medicines.org.uk/emc/product/14461/smpc. Accessed July 2023. 2. XIMLUCI EMA European Public Assessment Report. 2022. EMEA/H/C/005617/0000. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/Ximluci. Accessed February 2023.
* LUCENTIS. † Biosimilarity was concluded if the difference in mean change in BCVA at Week 8 was confined within the equivalence margin of ±3.5 letters. ‡ Efficacy analyses were performed on the Full Analysis Set, which included every patient who received at least one dose of either study drug. The primary endpoint was analysed using a Mixed Model for Repeated Measures (MMRM). To prove that the two products were biosimilar, the confidence limits had to be within the equivalence margin of 3.5 letters at Week 8, either 90% CI for US or 95% CI for the rest of the world. BCVA, best corrected visual acuity; CI, confidence interval.
Information
For information on our products please visit EMC, https://www.medicines.org.uk/emc/ and search the product for a Summary of Product Characteristics
Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Thornton and Ross Limited by emailing thorntonross@medinformation.co.uk or by calling 01484 848164.
UK-MULT-122a(2) | Date of Preparation: October 2023