Ranibizumab-Biosimilars Insight, 2022

January 2022 | 90 pages | ID: R5EB7116F777EN
DelveInsight

Abstracts

This report can be delivered to the clients within 72-96 hours

DelveInsight’s, “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.

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.

Further product details are provided in the report……..

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.

Further product details are provided in the report……..

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

DelveInsight’s 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

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

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

Contents

1. KEY INSIGHTS

2. 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. Xbrane
    9.1.1.1. Xlucane: Xbrane
      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. Samsung Bioepis
    9.1.2.1. SB-11: Samsung Bioepis
      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. Intas Biopharmaceuticals
    9.1.3.1. Razumab: Intas Biopharmaceuticals
      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. Coherus
    9.1.4.1. CHS-3351: Coherus
      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. DELVEINSIGHT CAPABILITIES

18. DISCLAIMER

19. ABOUT DELVEINSIGHT