Aflibercept biosimilar is under clinical development by Celltrion and currently in Pre-Registration for Age Related Macular Degeneration. According to GlobalData, Pre-Registration drugs for Age Related Macular Degeneration have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Aflibercept biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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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.
Aflibercept biosimilar overview
Aflibercept (Eydenzelt) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1. It is formulated as an iso-osmotic solution for the intravitreal route of administration. Eydenzelt is indicated for the treatment of neovascular (wet) age-related macular degeneration (wet AMD) and for the treatment of macular edema following central retinal vein occlusion. It is also indicated for non-proliferative diabetic retinopathy (NPDR), diabetic macular edema(DME) and Diabetic Retinopathy (DR) in Patients with DME, for the treatment of choroidal neovascularization and macular edema secondary to branch retinal vein occlusion (BRVO), for the treatment of visual impairment due to myopic choroidal neovascularization (myopic CNV), and all stages of non-proliferative diabetic retinopathy (DR), and thereby reduce the risk of blindness. It is based on trap technology.
Aflibercept biosimilar (CT-P42) is under development for the treatment of age related macular degeneration, wet age-related macular degeneration (wAMD), cystoid retinal vein occlusive (CRVO-BRVO) macular edema, choroidal neovascularization and diabetic macular edema. It is administered through intravitreal route. The drug candidate acts by targeting placenta growth factor (PGF), vascular endothelial growth factor A and B (VEGF A).
Celltrion overview
Celltrion is a biopharmaceutical company that focuses on the research, development, and manufacture of biosimilars and novel biopharmaceuticals. The company offers monoclonal antibodies for the treatment of rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, adult Crohn’s disease, psoriatic arthritis, and psoriasis. Its pipeline portfolio spans monoclonal antibody biosimilars for the treatment of rheumatoid arthritis; colorectal cancer; and respiratory disease; and antibody biologics and vaccines for infectious diseases such as hepatitis B, influenza, rabies, breast cancer, and seasonal influenza. Celltrion develops drugs by using its bioengineering and mammalian cell-culture technology. The company also carries out contract manufacturing of biosimilars. It has an operational presence in Korea, Russia, the UK, and the US. Celltrion is headquartered in Incheon, South Korea.
For a complete picture of Aflibercept biosimilar’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
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.
