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Rituximab - Biosimilars Insight, 2020

August 2020 | 125 pages | ID: R625842E868CEN
DelveInsight

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DelveInsight’s, “Rituximab– Biosimilar Insight, 2020,” report provides comprehensive insights about 35+ companies and 35+ marketed and pipeline drugs in Rituximab 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
Rituximab Understanding

Rituximab: Overview

Rituximab is a type of antibody therapy that can be used alone or with chemotherapy. They work in different ways to find and attack the cells where cancer starts. Rituximab targets and attaches to the CD20 protein found on the surface of blood cells with cancer and some healthy blood cells. Rituximab is used to treat certain types of cancer (such as non-Hodgkin's lymphoma, chronic lymphocytic leukemia). It works by slowing or stopping the growth of cancer cells. Some brands of rituximab are also used to treat rheumatoid arthritis and can decrease joint pain and swelling. This drug is also used to treat certain types of blood vessel disease (such as granulomatosis with polyangiitis, microscopic polyangiitis) and can decrease the swelling of the blood vessels. Rituximab is also used to treat a certain skin condition (pemphigus vulgaris). It helps to reduce the number of skin lesions.

Rituximab Biosimilars: Drugs Chapters

This segment of the Rituximab 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.

Rituximab Biosimilars: Marketed Drugs
  • Blitzima: Celltrion
Blitzima is a medicine used in adults to treat the following blood cancers and inflammatory conditions: follicular lymphoma and diffuse large B cell non-Hodgkin’s lymphoma (two types of non-Hodgkin’s lymphoma, a blood cancer); chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells); granulomatosis with polyangiitis (GPA or Wegener’s granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels. Depending on the condition it is used to treat, Blitzima may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids). Blitzima contains the active substance rituximab.
  • Rixathon: Sandoz
Rixathon is approved for non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. Depending on the condition it is used to treat, Rixathon may be given on its own, or with chemotherapy (cancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid).

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

Rituximab Biosimilars: Emerging Drugs
  • IBI301: Innovent Biologics
IBI301 is a potential biosimilar of rituximab, a recombinant human-mouse chimeric anti-CD20 monoclonal antibody for injection, and is being co-developed by Innovent and Eli Lilly and Company. Rituximab binds to the CD20 antigen on the surface of B lymphocytes and mediates complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC). Normal and malignant B cells are targeted for destruction by the antibody, thereby achieving anti-tumor and immunosuppressive therapeutic effects.
  • ABP 798: Allergan/Amgen
ABP 798 has been developed as a biosimilar candidate to Rituxan. Rituxan is an anti-CD20 monoclonal antibody that has been approved in many regions for the treatment of, among other things, adult patients alone or in combination with chemotherapy for non-Hodgkin's lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids. The active ingredient of ABP 798 is a monoclonal antibody that has the same amino acid sequence as Rituxan.

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

Rituximab: Therapeutic Assessment

This segment of the report provides insights about the different Rituximab biosimilars segregated based on following parameters that define the scope of the report, such as:
  • Major Players in Rituximab
There are approx. 35+ key companies which are developing the therapies for Rituximab.
  • Phases
DelveInsight’s report covers around 35+ 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
Rituximab 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.

Rituximab: Pipeline Development Activities

The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Rituximab 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 Rituximab biosimilar drugs.

Report Highlights
  • The companies and academics are working to assess challenges and seek opportunities that could influence Rituximab R&D. The therapies under development are focused on novel approaches to treat/improve Rituximab.
  • In January 2019, Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for RUXIENCE (rituximab), a potential biosimilar to MabThera (rituximab).
  • In December 2019, Amgen and Allergan announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Rituxan (rituximab). Amgen and Allergan are collaborating on four oncology biosimilar medicines, two of which have already been approved by the FDA.
  • In November 2019, Teva Pharmaceuticals and Celltrion Healthcare announced that TRUXIMA (rituximab-abbs) injection is the first biosimilar to the reference product Rituxan1 (rituximab) now available in the United States with a full oncology label. TRUXIMA is currently indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL):
Rituximab Biosimilars Report Insights
  • Rituximab Biosimilar Pipeline Analysis
  • Therapeutic Assessment
  • Sales Assessment
  • Unmet Needs
  • Impact of Drugs
Rituximab 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 Rituximab Biosimilars?
  • How many Rituximab 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 Rituximab biosimilars therapeutics?
  • What are the clinical studies going on for Rituximab biosimilars and their status?
  • What are the key designations that have been granted to the emerging drugs?
Key Players
  • Innovent Biologics
  • IQVIA (formely Quintiles Transnational Corp)
  • Gedeon Richter
  • BioIntegrator
  • Allergan
  • Amgen
  • Biocad
  • Celltrion
  • BioXpress Therapeutics
  • Dr. Reddy's Laboratories Limited
  • Sandoz
  • Shanghai Henlius Biotech
  • iBio
  • Inbiopro Solutions
  • Merck & Co.
  • Gedeon Richter
  • Zydus Cadila
  • Curaxys
  • Outlook Therapeutics
  • Apotex
  • mAbxience
  • Pfizer
  • Nichi-Iko Pharmaceutical/Aprogen
  • Sunshine Guojian Pharmaceutical
  • Lonza
  • Teva Pharmaceutical Industries
  • Reliance Life Sciences
  • PROBIOMED
  • LG Chem
  • GC Pharma
  • Hetero Group
  • HisunPharmaceuticals
  • BioXpress Therapeutics
  • International Biotech Center Generium
Key Products
  • IBI-301
  • RGB 03
  • RITUMAX
  • ABP 798
  • AcellBia/Usmal
  • Blitzima/Truxima
  • BX 2336
  • DRL_RI
  • GP2013
  • HLX01
  • iBio Rituximab
  • IBPB 001RX
  • MK-8808
  • Ritemvia/Blitzima
  • Riximyo
  • RTXM83
  • Ruxience
  • AP 052
  • Retuxira
  • TL-011
  • RituxiRel
  • Kikuzubam
  • LBRx
  • DRL-rituximab
  • MG1106
  • GB-241
  • Rilast
  • HS 006
  • BX 2336
  • GNR-006
1. KEY INSIGHTS

2. RITUXIMAB 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. RITUXIMAB (REFERENCE PRODUCT: RITUXAN)

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. RITUXAN BIOSIMILAR: EMERGING OPPORTUNITIES

8. RITUXIMAB: 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. RITUXIMAB BIOSIMILARS PROFILES: BY COMPANY

  9.1.1. Pfizer
    9.1.1.1. Ruxience: Pfizer
      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. Innovent Biologics
    9.1.2.1. IBI-301: Innovent Biologics
      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. Celltrion
    9.1.3.1. Blitzima: Celltrion
      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. Merck & Co.
    9.1.4.1. MK-8808: Merck & Co.
      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
  9.1.5. Sandoz
    9.1.5.1. Riximyo: Sandoz
      9.1.5.1.1. Product Information
      9.1.5.1.2. Research and Development
      9.1.5.1.3. Other Development Activities
      9.1.5.1.4. General Description Table
    9.1.5.2. GP2013: Sandoz
      9.1.5.2.1. Product Information
      9.1.5.2.2. Research and Development
      9.1.5.2.3. Other Development Activities
      9.1.5.2.4. General Description Table
*More Companies and products would be added in the final report

10. RITUXIMAB BIOSIMILARS: COMPARATIVE LANDSCAPE: BY COMPANY

11. RITUXIMAB 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

LIST OF TABLES

Table 1 Total Products for Rituximab
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 Rituximab
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


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