This “Ranibizumab- Biosimilar 2022” report provides comprehensive insights about 20+ companies and 20+ 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.
Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that has been approved to treat the "wet" type of age-related macular degeneration, a common form of age-related vision loss. Its effectiveness is similar to that of bevacizumab. Ranibizumab was developed by Genentech and marketed by them in the United States, and elsewhere by Novartis, under the brand name Lucentis. It is often used for age-related wet macular degeneration. Its effectiveness is similar to that of bevacizumab and aflibercept.
This segment of the Ranibizumab report encloses its detailed analysis of various drugs in different stages of clinical development, including marketed, phase III, II, I and preclinical. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Razumab: Intas Pharmaceuticals
Razumab is the tenth biosimilar launched by Intas in India, by far the largest number of indigenously developed biosimilars by any company. Since 2004, when Intas launched its first biosimilar, Intas has constantly worked to bring the latest in biological therapies to Indian patients at affordable prices. With its robust pipeline of future products under development, Intas aims to continue on this endeavor. Till date, Intas is also the only company from India to have launched a biosimilar in the highly regulated European market and is also the only company from India to have two of its biosimilars filed for registration in the US. Its first biosimilar for global markets, Accofil (filgratsim) was launched in Europe earlier this year. The company expects to launch its first biosimilar in the US within the next 9 - 12 months. Intas' manufacturing facilities are approved by global regulatory agencies such as EMA, ANVISA, WHO and others. Razumab is also manufactured in the same facilities as its other biosimilars.
SB-11: Samsung Bioepis
SB11 is a ranibizumab biosimilar candidate, to reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD). The drug is currently in phase III stage of development.
There are approx. 20+ key companies which are developing the therapies for Ranibizumab.
The report covers around 20+ products under different phases of clinical development like
The drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
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.
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Ranibizumab biosimilar drugs.
Geography Covered
- Global coverage
Ranibizumab Understanding
Ranibizumab: Overview
Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that has been approved to treat the "wet" type of age-related macular degeneration, a common form of age-related vision loss. Its effectiveness is similar to that of bevacizumab. Ranibizumab was developed by Genentech and marketed by them in the United States, and elsewhere by Novartis, under the brand name Lucentis. It is often used for age-related wet macular degeneration. Its effectiveness is similar to that of bevacizumab and aflibercept.
Ranibizumab Biosimilars: Drugs Chapters
This segment of the Ranibizumab report encloses its detailed analysis of various drugs in different stages of clinical development, including marketed, phase III, II, I and preclinical. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Ranibizumab Biosimilars: Marketed Drugs
Razumab: Intas Pharmaceuticals
Razumab is the tenth biosimilar launched by Intas in India, by far the largest number of indigenously developed biosimilars by any company. Since 2004, when Intas launched its first biosimilar, Intas has constantly worked to bring the latest in biological therapies to Indian patients at affordable prices. With its robust pipeline of future products under development, Intas aims to continue on this endeavor. Till date, Intas is also the only company from India to have launched a biosimilar in the highly regulated European market and is also the only company from India to have two of its biosimilars filed for registration in the US. Its first biosimilar for global markets, Accofil (filgratsim) was launched in Europe earlier this year. The company expects to launch its first biosimilar in the US within the next 9 - 12 months. Intas' manufacturing facilities are approved by global regulatory agencies such as EMA, ANVISA, WHO and others. Razumab is also manufactured in the same facilities as its other biosimilars.
Ranibizumab Biosimilars: Emerging Drugs
SB-11: Samsung Bioepis
SB11 is a ranibizumab biosimilar candidate, to reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD). The drug is currently in phase III stage of development.
Ranibizumab: 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. 20+ key companies which are developing the therapies for Ranibizumab.
Phases
The report covers around 20+ 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
- Subcutaneous
- Intravenous
- Molecule Type
Products have been categorized under various Molecule types such as
- Monoclonal antibodies
- Peptide
- Protein
- Small molecule
Product Type
The 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.
Report Highlights
- 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 May 2020, Samsung Bioepis announced that the primary endpoints have been met in the randomized, double-masked, phase 3 trial comparing the efficacy, safety and immunogenicity of SB11, a ranibizumab biosimilar candidate, to reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD).
- In November 2019, Coherus BioSciences announced the Company has acquired exclusive rights from Bioeq to commercialize Bioeq's biosimilar candidate to Lucentis (ranibizumab) in the United States. Bioeq plans to file a Biologics License Application with the U.S. Food and Drug Administration in the fourth quarter of 2019 and Coherus plans to launch the product in 2021.
- In April 2020, Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane (ranibizumab) biosimilar product, and that it is still on track towards regulatory approval ahead of Lucentis patent expiration in the EU.
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
Key Questions Answered
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?
Key Players
- Xbrane
- Senju Pharmaceutical
- Samsung Bioepis
- Polus BioPharm
- PlantForm Corporation
- Pfenex
- Lupin
- Intas Biopharmaceuticals
- Ildong Pharmaceutical
- Harvest Moon Pharmaceuticals
- Gene Techno Science
- Coherus
- Chong Kun Dang
- Biocure Technology
- BIOCND
- Qilu Pharmaceuticals
- Bioeq
- Formycon
Key Products
- Xlucane
- SJP 0133
- SB-11
- PDP807
- PF582
- Razumab
- IDB-0062
- GBS-007
- CHS-3351
- CKD-701
- BCD 300
- FYB201
Table of Contents
1. Key Insights2. Ranibizumab Biosimilars: Snapshot
3. Executive Summary
3.1. Overview
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
4.1.1. US
4.1.2. Canada
4.2. Europe
4.3. Asia Pacific
4.3.1. China
4.3.2. India
4.3.3. Japan
4.3.4. South Korea
4.3.5. Australia
4.4. Rest Of The World
4.4.1. Brazil
4.4.2. Mexico
4.4.3. Argentina
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
5.4. Indications
5.5. Mechanism of Action
5.6. Dosage and Administration
5.7. Dosage and Strengths
5.8. Dose Modification
5.9. Route of Synthesis
5.10. Pharmacology
5.11. Pharmacodynamics
5.12. Pharmacokinetics
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
9.1.1.1. Razumab: Intas Pharmaceuticals
9.1.1.1.1. Product Information
9.1.1.1.2. Research and Development
9.1.1.1.3. Other Development Activities
9.1.1.1.4. General Description Table
9.1.2. GENERIUM Pharmaceuticals
9.1.2.1. GNR067: GENERIUM Pharmaceuticals
9.1.2.1.1. Product Information
9.1.2.1.2. Research and Development
9.1.2.1.3. Other Development Activities
9.1.2.1.4. General Description Table
9.1.3. Xbrane
9.1.3.1. Xlucane: Xbrane
9.1.3.1.1. Product Information
9.1.3.1.2. Research and Development
9.1.3.1.3. Other Development Activities
9.1.3.1.4. General Description Table
9.1.4. BIOCND/Qilu Pharmaceuticals
9.1.4.1. BCD 300: BIOCND/Qilu Pharmaceuticals
9.1.4.1.1. Product Information
9.1.4.1.2. Research and Development
9.1.4.1.3. Other Development Activities
9.1.4.1.4. 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
11.1.1. Overview
11.1.2. Market Share Analysis
11.1.3. Competitive Scenario
11.1.3.1. Product Launches and approval
11.1.3.2. Partnerships, Collaborations and Agreements
11.1.3.3. Acquisitions
11.1.3.4. Expansions
11.1.3.5. Patent Expiration of Biologics
*More information would be added in the final report
12. Market Drivers
13. Market Barriers
14. SWOT Analysis
15. Appendix
15.1. Research Methodology
15.1.1. Coverage
15.1.2. Secondary Research
16. Bibliography
17. The Publisher Capabilities
18. Disclaimer
19. About The Publisher
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
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Intas Pharmaceuticals
- Reliance Life Sciences
- Senju Pharmaceutical
- Lupin
- Samsung Bioepis
- Xbrane
- 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
- Polus
- Enzene Biosciences
- Paras Biopharmaceuticals
