Ranibizumab biosimilar is under clinical development by Xbrane Biopharma and currently in Phase III for Diabetic Macular Edema. According to GlobalData, Phase III drugs for Diabetic Macular Edema have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Ranibizumab biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Ranibizumab biosimilar overview

Ranibizumab (Ximluci) is a humanized monoclonal antibody fragment and a recombinant humanized IgO 1 isotype. It is formulated as a solution for the intravitreal route of administration. Ximluci is indicated in adults for the treatment of the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular edema, proliferative diabetic retinopathy, visual impairment due to macular edema secondary to retinal vein occlusion, and for treatment of visual impairment due to choroidal neovascularization.

Ranibizumab biosimilar (Xlucane) is under development for the treatment of wet form of age-related macular degeneration (AMD), diabetic macular edema, diabetic related retinopathy and retinal vein occlusion. It is administered as intravitreal injection. The therapeutic candidate is developed based on protein production platform.

Xbrane Biopharma overview

Xbrane Biopharma (Xbrane), formerly Xbrane Bioscience is a biopharmaceutical company. It develops and manufactures complex generic products . The company’s product portfolio includes biosimilars and long acting injectables developed for people suffering from critical diseases. It combines its proprietary microsphere and protein production technology platforms to develop and produce generics drugs for controlled release of the active substance through encapsulation in microspheres. The company’s products find application in treating diseases across various therapeutic areas including acromegaly and neuroendocrine tumours, prostate cancer, endometriosis and uterine fibroids; age-related macular degeneration and macular oedema, among others. Xbrane is headquartered in Stockholm, Sweden.

For a complete picture of Ranibizumab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 15 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.