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Posted on October 13, 2021 by admin Ranibizumab Biosimilar Insight, 2021: DelveInsight
Ranibizumab Biosimilar Insight Overview
Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. It is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and myopic choroidal neovascularization (mCNV).
DelveInsight's, Ranibizumab Biosimilar Insight , 2021 report provides comprehensive insights about Ranibizumab Biosimilars landscape. It covers the marketed and pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
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Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product.
Ranibizumab (Lucentis) is a sterile, colorless to pale yellow solution in a single-use glass vial. Lucentis is supplied as a preservative-free, sterile solution in a single-use glass vial designed to deliver 0.05 mL of 10 mg/mL Lucentis (0.5 mg dose vial) or 6 mg/mL Lucentis (0.3 mg dose vial) aqueous solution with 10 mM histidine HCl, 10% α,α-trehalose dihydrate, 0.01% polysorbate 20, pH 5.5.
Ranibizumab Biosimilar Insight Companies are-
- Senju Pharmaceutical
- Samsung Bioepis
- Polus BioPharm
- PlantForm Corporation
- Intas Biopharmaceuticals
- Ildong Pharmaceutical
- Harvest Moon Pharmaceuticals
- Gene Techno Science
- Chong Kun Dang
- Biocure Technology
- Qilu Pharmaceuticals
- And many others
Ranibizumab Biosimilar Insight Products
- SJP 0133
- BCD 300
- And many others
Ranibizumab Biosimilar Insight Mechanism of Action
Ranibizumab binds to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and is thought to contribute to pathophysiology of neovascular AMD, macular edema following RVO, and DME. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.
Ranibizumab Biosimilar Insight Pharmacodynamics
Increased retinal thickness (i.e., center point thickness (CPT) or central foveal thickness (CFT)), as assessed by optical coherence tomography (OCT) is associated with neovascular AMD, macular edema following RVO, and DME. Leakage from choroidal neovascularization (CNV) as assessed by fluorescein angiography (FA) is associated with neovascular AMD.
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Table of content
1. Key Insights
2. Ranibizumab Biosimilars: Snapshot
3. Executive Summary
4. Regulatory Outlook for Biosimilars
5. Ranibizumab (Reference Product: Lucentis)
6. Research and Development
7. Lucentis Biosimilar: Emerging Opportunities
8. Ranibizumab: Biosimilars Assessment
9. Ranibizumab Biosimilars Profiles: By Company
10. Ranibizumab Biosimilars: Comparative Landscape: By Company
11. Ranibizumab Biosimilars: Competitive Landscape
12. Market Drivers
13. Market Barriers
14. SWOT Analysis
17. DelveInsight Capabilities
19. About DelveInsight
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DelveInsight is a Business Consulting and Market research company, providing expert business solutions for life science vertical and offering quintessential advisory services in the areas of R & D, Strategy Formulation, Operations, Competitive Intelligence, Competitive Landscaping, and Mergers & Acquisitions.
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