This “Infliximab- Biosimilar 2022” report provides comprehensive insights about 35+ companies and 45+ marketed and pipeline drugs in Infliximab 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.
Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. Infliximab is produced by a recombinant cell line cultured by continuous perfusion. Tumor necrosis factor-alpha (TNF-α) is a key proinflammatory cytokine involved in chronic inflammatory diseases. Its hyperactivity and enhanced signalling pathways can be observed in inflammatory diseases where it activates further pro-inflammatory cascades. By binding to both the soluble subunit and the membrane-bound precursor of TNF-α 1, infliximab disrupts the interaction of TNF-α with its receptors and may also cause lysis of cells that produce TNF-α 1
This segment of the Infliximab 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.
Inflectra: Celltrion/Pfizer
Inflectra will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be available in the U.S. It is approved for the treatment of:adult patients and pediatric patients (ages six years and older) with moderate to severely active Crohn's disease who have had an inadequate response to conventional therapy;adult patients with moderate to severely active ulcerative colitis who have had an inadequate response to conventional therapy; andmmoderate to severely active rheumatoid arthritis in combination with methotrexate; active ankylosing spondylitis; active psoriatic arthritis; and chronic severe plaque psoriasis.
Renflexis: Merck
Crohn's Disease (moderately to severely active): Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn's disease who haven't responded well to other therapies
Pediatric Crohn's Disease (moderately to severely active): Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn's disease who haven't responded well to other therapies
Ulcerative Colitis (moderately to severely active): Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven't responded well to other therapies
Pediatric Ulcerative Colitis (moderately to severely active): Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in children (ages 6-17) with moderately to severely active ulcerative colitis who haven't responded well to other therapies
BCD 055: Biocad
A biosimilar of infliximab, designated as BCD 055, is being developed by Biocad for the treatment of ankylosing spondylitis and rheumatoid arthritis.
CT-P17: Celltrion
Genor Biopharma (a subsidiary of Walvax Biotechnology) is developing a biosimilar of infliximab, designated as GB 242, for the treatment of Autoimmune disorders; Rheumatoid arthritis. The drug is currently in phase III stage of development.
There are approx. 20+ key companies which are developing the therapies for Infliximab.
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 Infliximab 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 Infliximab biosimilar drugs.
Geography Covered
- Global coverage
Infliximab Understanding
Infliximab: Overview
Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet's disease. Infliximab is produced by a recombinant cell line cultured by continuous perfusion. Tumor necrosis factor-alpha (TNF-α) is a key proinflammatory cytokine involved in chronic inflammatory diseases. Its hyperactivity and enhanced signalling pathways can be observed in inflammatory diseases where it activates further pro-inflammatory cascades. By binding to both the soluble subunit and the membrane-bound precursor of TNF-α 1, infliximab disrupts the interaction of TNF-α with its receptors and may also cause lysis of cells that produce TNF-α 1
Infliximab Biosimilars: Drugs Chapters
This segment of the Infliximab 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.
Infliximab Biosimilars: Marketed Drugs
Inflectra: Celltrion/Pfizer
Inflectra will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be available in the U.S. It is approved for the treatment of:adult patients and pediatric patients (ages six years and older) with moderate to severely active Crohn's disease who have had an inadequate response to conventional therapy;adult patients with moderate to severely active ulcerative colitis who have had an inadequate response to conventional therapy; andmmoderate to severely active rheumatoid arthritis in combination with methotrexate; active ankylosing spondylitis; active psoriatic arthritis; and chronic severe plaque psoriasis.
Renflexis: Merck
Renflexis is a prescription medicine that treats the following autoimmune diseases:
Crohn's Disease (moderately to severely active): Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn's disease who haven't responded well to other therapies
Pediatric Crohn's Disease (moderately to severely active): Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn's disease who haven't responded well to other therapies
Ulcerative Colitis (moderately to severely active): Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven't responded well to other therapies
Pediatric Ulcerative Colitis (moderately to severely active): Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in children (ages 6-17) with moderately to severely active ulcerative colitis who haven't responded well to other therapies
Infliximab Biosimilars: Emerging Drugs
BCD 055: Biocad
A biosimilar of infliximab, designated as BCD 055, is being developed by Biocad for the treatment of ankylosing spondylitis and rheumatoid arthritis.
CT-P17: Celltrion
Genor Biopharma (a subsidiary of Walvax Biotechnology) is developing a biosimilar of infliximab, designated as GB 242, for the treatment of Autoimmune disorders; Rheumatoid arthritis. The drug is currently in phase III stage of development.
Infliximab: Therapeutic Assessment
This segment of the report provides insights about the different Infliximab biosimilars segregated based on following parameters that define the scope of the report, such as:
Major Players in Infliximab
There are approx. 20+ key companies which are developing the therapies for Infliximab.
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
Infliximab 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
- Parenteral
- 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.
Infliximab: Pipeline Development Activities
The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Infliximab 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 Infliximab biosimilar drugs.
Report Highlights
- The companies and academics are working to assess challenges and seek opportunities that could influence Infliximab R&D. The therapies under development are focused on novel approaches to treat/improve Infliximab.
- In July 2017, Merck had launched in the U.S. a biosimilar of Remicade (infliximab), the blockbuster immune-mediated inflammatory disorders treatment it markets outside the U.S., including Europe, while partner Janssen Biotech markets the drug stateside.
- In December 2017, Pfizer announced that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade (infliximab) for all eligible indications of the reference product. The FDA has approved IXIFI as a treatment for patients with rheumatoid arthritis, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
Infliximab Biosimilars Report Insights
- Infliximab Biosimilar Pipeline Analysis
- Therapeutic Assessment
- Sales Assessment
- Unmet Needs
- Impact of Drugs
Infliximab 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 Infliximab Biosimilars?
- How many Infliximab 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 Infliximab biosimilars therapeutics?
- What are the clinical studies going on for Infliximab biosimilars and their status?
- What are the key designations that have been granted to the emerging drugs?
Key Players
- Sandoz
- Samsung Bioepis
- Merck
- Nichiiko Pharmaceutical
- Aprogen
- Nichi-Iko Pharmaceutical
- MabPharm
- Sorrento
- LG Chem
- Hospira
- Harvest Moon Pharmaceuticals
- Genor Biopharma
- EPIRUS
- Reliance Life Sciences
- Curaxys
- Pfizer
- Celltrion
- Biocad
- Amgen
Key Products
- Zessly
- Renflexis/SB2
- SB2
- Infimab
- Ixifi
- GS 071
- NI-071
- CMAB008
- STI-002
- LBIM-0101
- Inflectra
- GB 242
- BOW015
- Inflectra
- Remsima
- BCD-055
- Avsola
Table of Contents
1. Key Insights2. Infliximab 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. Infliximab (Reference Product: Remicade)
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. Remicade Biosimilar: Emerging Opportunities
8. Infliximab: 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. Infliximab Biosimilars Profiles: By Company
9.1.1. Pfizer
9.1.1.1. Ixifi: 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. Samsung Bioepis
9.1.2.1. SB2: 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. Celltrion
9.1.3.1. CT-P17: 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. Nichiiko Pharmaceutical
9.1.4.1. GS 071: Nichiiko Pharmaceutical
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. Zessly: 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
*More Companies and products would be added in the final report
10. Infliximab Biosimilars: Comparative Landscape: By Company
11. Infliximab 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. Publisher Capabilities
18. Disclaimer
19. About the PublisherList of Tables
Table 1 Total Products for Infliximab
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 ProductsList of Figures
Figure 1 Total Products for Infliximab
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:
- Celltrion/Pfizer
- Merck
- Biocad
