Ranibizumab Biosimilars Insight
DelveInsight’s, “Ranibizumab Biosimilar Insight, 2023” report provides comprehensive insights about 17+ companies and 17+ marketed and pipeline drugs in 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.
- Global coverage
Lucentis (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). 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.
LUCENTIS 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)
- Diabetic Retinopathy (DR)
- Myopic Choroidal Neovascularization (mCNV)
"Ranibizumab Biosimilars - Pipeline Insight, 2023" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Ranibizumab Biosimilars pipeline landscape is provided which includes the disease overview and Ranibizumab Biosimilars treatment guidelines. The assessment part of the report embraces, in depth Ranibizumab Biosimilars commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Ranibizumab Biosimilars collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
Ranibizumab Biosimilars Market: Drug Chapters
Razumab: Intas Pharmaceuticals
Razumab injection is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use and a biosimilar to Ranibizumab. The binding of Razumab to VEGF-A prevents the interaction of VEGF-A with its receptors VEGFR-1 and VEGFR-2 on the surface of endothelial cells and thus inhibit the endothelial cell proliferation, neovascularization and vascular leakage. Razumab has a molecular weight of approximately 48 kilo Daltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. In June 2015, Intas became the first company globally to develop and launch a biosimilar version of Ranibizumab. RAZUMAB™ is manufactured under strict guidelines for sterile use in the eye and is offered as single dose vial, thus reducing the risk of contamination during use. Intas’ ranibizumab, RAZUMAB is a 100 per cent ‘Made in India’ molecule, a feat achieved by the scientists at Intas and unparalleled till date. It was approved by the Drug Controller General of India for the treatment of Neovascular (Wet) Age-related Macular Degeneration (Wet-AMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO), and Choroidal neovascularization (CNV).
RanizuRel: Reliance Life Sciences
RanizuRel™ (Ranibizumab) is a recombinant humanized IgG1K isotype monoclonal antibody fragment that selectively binds to inhibit biological activity of human vascular endothelial growth factor A (VEGF-A). It is produced in an E.Coli expression system and has a molecular weight of 48 kilodaltons. RanizuRel™ is indicated in Neovascular (Wet) Age-Related Macular Degeneration (AMD) and administered by intravitreal injection. It is recommended to administer RanizuRel once a month (approximately 28 days). The intravitreal injection procedure should be carried out under controlled aseptic conditions. RanizuRel™ is sterile, preservative-free, and clear colourless to pale yellow solution available in 0.5 mg dose single-use vial.
Ranibizumab Biosimilars Emerging Drugs
Xlucane is a ranibizumab (Lucentis) biosimilar candidate, a so-called VEGF-A inhibitor, intended to be used to treat a number of serious eye diseases: wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), as well as retinal vein occlusion (RVO). A pivotal phase III study, XPLORE, is being conducted to demonstrate equivalence to Lucentis. In October 2021, a Marketing Authorization Application (MAA) for biosimilar ranibizumab that was submitted by Xbrane co-development and commercialization partner, STADA Arzneimittel AG was validated by the European Medicines Agency (EMA).
GNR-067: GENERIUM Pharmaceuticals
GNR-067 is a ranibizumab biosimilar being developed by Generium Pharmaceuticals. 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, mCNV, DR, DME and macular edema following RVO. 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. Currently, it is in Phase III stage of clinical trial evaluation to treat wet Age-related Macular Degeneration.
Further product details are provided in the report……..
Ranibizumab Biosimilars Market: Therapeutic Assessment
This segment of the report provides insights about the different Ranibizumab biosimilars segregated based on following parameters that define the scope of the report, such as:
- Major Players in Ranibizumab
There are approx. 17+ key companies which are developing the therapies for Ranibizumab.
DelveInsight’s report covers around 17+ products under different phases of clinical development like
- Marketed stage products
- Late stage products (BLA Filed and Phase III)
- Mid-stage products (Phase II and
- Early-stage products (Phase I) along with the details of
- Pre-clinical and Discovery stage candidates
- Discontinued & Inactive candidates
- Route of Administration
Ranibizumab pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
- Molecule Type
Products have been categorized under various Molecule types such as
- Monoclonal Antibody
- Small molecule
- Gene therapy
- Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
Ranibizumab: Pipeline Development Activities
The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Ranibizumab biosimilars drugs key players involved in developing key drugs.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Ranibizumab biosimilar drugs.
The companies and academics are working to assess challenges and seek opportunities that could influence Ranibizumab R&D. The therapies under development are focused on novel approaches to treat/improve Ranibizumab.
- In April 2021, Xbrane Partnered with Bausch & Lomb to enter the US market. In October 2021, a Marketing Authorization Application (MAA) for biosimilar ranibizumab that was submitted by Xbrane co-development and commercialization partner, STADA Arzneimittel AG was validated by the European Medicines Agency (EMA).
- In October 2021, Coherus BioSciences announced the United States Food and Drug Administration (FDA) has accepted for review the 351(k) Biologics License Application (BLA) for CHS-201, a biosimilar candidate of reference product Lucentis® (ranibizumab). The FDA has set a Biosimilar User Fee Act action date for August 2, 2023, and, if approved, Coherus plans to launch the Lucentis biosimilar in the U.S. in the second half of 2022.
Ranibizumab Biosimilars Report Insights
- Ranibizumab Biosimilar Pipeline Analysis
- Therapeutic Assessment
- Sales Assessment
- Unmet Needs
- Impact of Drugs
Ranibizumab Biosimilar Report Assessment
- Marketed Product profiles
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Sales Assessment
- Inactive drugs assessment
- Unmet Needs
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing Ranibizumab Biosimilars?
- How many Ranibizumab biosimilars are developed by each company?
- How many emerging biosimilars are in mid-stage, and late-stage?
- What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Ranibizumab biosimilars therapeutics?
- What are the clinical studies going on for Ranibizumab biosimilars and their status?
- What are the key designations that have been granted to the emerging drugs?
1. Key Insights
2. Ranibizumab Biosimilars: Snapshot
3. Executive Summary
3.2. The Basics of Biologics.
3.3. Biosimilars are not the Same as Generic Drugs
3.4. Economics of Biosimilars – the Promise of Lower Prices, but at What Cost?
3.5. What Patients Need to Know About Biosimilars
4. Regulatory Outlook For Biosimilars
4.1. North America
4.3. Asia Pacific
4.3.4. South Korea
4.4. Rest Of The World
4.4.4. Saudi Arabia
*More Countries would be added in the final report
5. Ranibizumab (Reference Product: Lucentis)
5.1. Drug Profile
5.2. Product Overview
5.3. Regulatory Approvals and Launch
5.5. Mechanism of Action
5.6. Dosage and Administration
5.7. Dosage and Strengths
5.8. Dose Modification
5.9. Route of Synthesis
5.13. Adverse Reactions
5.14. Product Snapshot
5.15. Development Milestones
6. Research and Development
6.1. Clinical Trials Information
6.2. Safety and Efficacy
7. Lucentis Biosimilar: Emerging Opportunities
8. Ranibizumab: Biosimilars Assessment
8.1. Assessment by Product Type
8.2. Assessment by Route of Administration
8.3. Assessment by Molecule type
8.4. Sales Assessment
9. Ranibizumab Biosimilars Profiles: By Company
9.1.1. Intas Biopharmaceuticals
18.104.22.168. Razumab: Intas Pharmaceuticals
22.214.171.124.1. Product Information
126.96.36.199.2. Research and Development
188.8.131.52.3. Other Development Activities
184.108.40.206.4. General Description Table
9.1.2. GENERIUM Pharmaceuticals
220.127.116.11. GNR067: GENERIUM Pharmaceuticals
18.104.22.168.1. Product Information
22.214.171.124.2. Research and Development
126.96.36.199.3. Other Development Activities
188.8.131.52.4. General Description Table
184.108.40.206. Xlucane: Xbrane
220.127.116.11.1. Product Information
18.104.22.168.2. Research and Development
22.214.171.124.3. Other Development Activities
126.96.36.199.4. General Description Table
9.1.4. BIOCND/Qilu Pharmaceuticals
188.8.131.52. BCD 300: BIOCND/Qilu Pharmaceuticals
184.108.40.206.1. Product Information
220.127.116.11.2. Research and Development
18.104.22.168.3. Other Development Activities
22.214.171.124.4. General Description Table
*More Companies and products would be added in the final report
10. Ranibizumab Biosimilars: Comparative Landscape: By Company
11. Ranibizumab Biosimilars: Competitive Landscape
11.1.2. Market Share Analysis
11.1.3. Competitive Scenario
126.96.36.199. Product Launches and approval
188.8.131.52. Partnerships, Collaborations and Agreements
184.108.40.206. Patent Expiration of Biologics
*More information would be added in the final report
12. Market Drivers
13. Market Barriers
14. SWOT Analysis
15.1. Research Methodology
15.1.2. Secondary Research
17. DelveInsight Capabilities
19. About DelveInsight
List of Tables
Table 1: Total Products for Ranibizumab Biosimilars
Table 2: Late Stage Products
Table 3: Mid Stage Products
Table 4: Early Stage Products
Table 5: Pre-clinical & Discovery Stage Products
Table 6: Assessment by Product Type
Table 7: Assessment by Stage and Product Type
Table 8: Assessment by Route of Administration
Table 9: Assessment by Stage and Route of Administration
Table 10: Assessment by Molecule Type
Table 11: Assessment by Stage and Molecule Type
Table 12: Inactive Products
List of Figures
Figure 1: Total Products for Ranibizumab Biosimilars
Figure 2: Late Stage Products
Figure 3: Mid Stage Products
Figure 4: Early Stage Products
Figure 5: Preclinical and Discovery Stage Products
Figure 6: Assessment by Product Type
Figure 7: Assessment by Stage and Product Type
Figure 8: Assessment by Route of Administration
Figure 9: Assessment by Stage and Route of Administration
Figure 10: Assessment by Molecule Type
Figure 11: Assessment by Stage and Molecule Type
Figure 12: Inactive Products
• Intas Pharmaceuticals
• Reliance Life Sciences
• Senju Pharmaceutical
• Samsung Bioepis
• Formycon/Bioeq/Coherus BioSciences
• Chong Kun Dang Pharmaceutical
• BIOCND/Qilu Pharmaceuticals
• GENERIUM Pharmaceuticals
• Shanghai Biomabs Pharmaceutical
• Celon pharma
• Biocure Technology
• Clonz Biotech
• PlantForm Corporation
• Siam Bioscience
• Enzene Biosciences
• Paras Biopharmaceuticals