Remicade (Infliximab) Biosimilar Clinical Trial Insight

Publish Date:- Oct-2016       No Of Pages (50)

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“Remicade (Infliximab) Biosimilar Clinical Trial Insight” report by PNS Pharma gives comprehensive clinical insight on 17 biosimilar version of Remicade drug in clinical pipeline. Currently there are 2 biosimilars in Phase-III trials and are expected to be commercially available in next 5-8 years. Currently 3 biosimilar version of Remicade are commercially available in India, Brazil and European countries for the treatment of Ankylosing spondylitis, Crohn's disease and Rheumatoid Arthritis. The patent on Remicade is set to expire in 2018 for US and 2017 for rest of world.

Remicade is the trade name for infliximab which is a chimeric monoclonal antibody biologic drug, marketed by Janssen Biotech. Infliximab is used to fight against tumor necrosis factor alpha (TNF-α) to treat auto immune diseases such as rheumatoid arthritis. The drug is a purified form of recombinant DNA-derived human-mouse monoclonal antibodies consisting of mouse and human’s heavy and light chain variable regions. It is a prescribed drug, approved by Food and Drug Association for the treatment of Crohn’s disease, Pediatric Crohn’s disease, Ulcerative colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing spondylitis and Plaque psoriatic.

FDA approved infliximab in September 2006, for chronic Plaque Psoriasis. Infliximab comes under the form of naturally occurring antibodies (anti-TNF bodies) with the ability to neutralize all forms of TNF.  It is capable of breaking down of cell causing inflammatory process. Biological activities such as pro inflammatory cytokines, enhancement of leukocyte movement and increasing the release of adhesion molecules are attributed to TNF-α.

Infliximab is made up of human and mouse antibodies. It is an artificial antibody originally developed from mice. Due to human immune reaction to mouse proteins, the mouse common domains are replaced with human antibody domains. Infliximab is has main key components as human mouse antibody amino acids because of which is referred as  chimeric monoclonal antibody. 

Infliximab works by binding action of remicade with TNF-α. Playing a crucial role in auto immune systems, TNF-α is a chemical messenger. In the case of rheumatoid arthritis, infliximab works to prevent TNF-α by attaching to its receptor in the cell. Infliximab works by neutralizing the biological activity of TNF-α. It inhibits the functional activity of wide variety utilizing human fibroblasts, endothelial cells, neutrophils, B and T-lymphocytes and epithelial cells. Though, the biological responses through which remicade exert clinical effects in the body are still considered to be unknown.

Remicade is necessarily induced intravenously because of the fact that the drug can be destroyed by the digestive system of a patient in case given by mouth. The dosages are typically administered by infusion within the interval of 6 to 8 weeks. The initial process involves the 3 starter infusions over first 6 weeks, followed by 2 more after next 2 and 4 weeks. Along with remicade, patients are prescribed with a particular amount of medication, depending upon the patient’s weight to reduce its side effects

Similar to other TNF inhibitors, infliximab is an expensive drug costing range from  US$ 1300 – US$ 2500 for every dosage. It is manufactured as a sterile lyophilized white freeze dried powder which necessarily requires administration and reconstitution by a health care professional. Due to this need of extra care during treatment and infusion of remicade, it is a part of major health insurances.


“Remicade (Infliximab) Biosimilar Clinical Trial Insight” report by PNS Pharma gives comprehensive clinical insight on 17 biosimilar version of Remicade drug in clinical pipeline. Currently there are 2 biosimilars in Phase-III trials and are expected to be commercially available in next 5-8 years. Currently 3 biosimilar version of Remicade are commercially available in India, Brazil and European countries for the treatment of Ankylosing spondylitis, Crohn's disease and Rheumatoid Arthritis. The patent on Remicade is set to expire in 2018 for US and 2017 for rest of world.

Remicade is the trade name for infliximab which is a chimeric monoclonal antibody biologic drug, marketed by Janssen Biotech. Infliximab is used to fight against tumor necrosis factor alpha (TNF-α) to treat auto immune diseases such as rheumatoid arthritis. The drug is a purified form of recombinant DNA-derived human-mouse monoclonal antibodies consisting of mouse and human’s heavy and light chain variable regions. It is a prescribed drug, approved by Food and Drug Association for the treatment of Crohn’s disease, Pediatric Crohn’s disease, Ulcerative colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing spondylitis and Plaque psoriatic.

FDA approved infliximab in September 2006, for chronic Plaque Psoriasis. Infliximab comes under the form of naturally occurring antibodies (anti-TNF bodies) with the ability to neutralize all forms of TNF.  It is capable of breaking down of cell causing inflammatory process. Biological activities such as pro inflammatory cytokines, enhancement of leukocyte movement and increasing the release of adhesion molecules are attributed to TNF-α.

Infliximab is made up of human and mouse antibodies. It is an artificial antibody originally developed from mice. Due to human immune reaction to mouse proteins, the mouse common domains are replaced with human antibody domains. Infliximab is has main key components as human mouse antibody amino acids because of which is referred as  chimeric monoclonal antibody. 

Infliximab works by binding action of remicade with TNF-α. Playing a crucial role in auto immune systems, TNF-α is a chemical messenger. In the case of rheumatoid arthritis, infliximab works to prevent TNF-α by attaching to its receptor in the cell. Infliximab works by neutralizing the biological activity of TNF-α. It inhibits the functional activity of wide variety utilizing human fibroblasts, endothelial cells, neutrophils, B and T-lymphocytes and epithelial cells. Though, the biological responses through which remicade exert clinical effects in the body are still considered to be unknown.

Remicade is necessarily induced intravenously because of the fact that the drug can be destroyed by the digestive system of a patient in case given by mouth. The dosages are typically administered by infusion within the interval of 6 to 8 weeks. The initial process involves the 3 starter infusions over first 6 weeks, followed by 2 more after next 2 and 4 weeks. Along with remicade, patients are prescribed with a particular amount of medication, depending upon the patient’s weight to reduce its side effects

Similar to other TNF inhibitors, infliximab is an expensive drug costing range from  US$ 1300 – US$ 2500 for every dosage. It is manufactured as a sterile lyophilized white freeze dried powder which necessarily requires administration and reconstitution by a health care professional. Due to this need of extra care during treatment and infusion of remicade, it is a part of major health insurances.

1. Remicade (Infliximab) Clinical Insight

  1.1 Clinical Introduction

  1.2 Company Partnerships & Agreements

  1.3 Patent Analysis by Indication

  1.4 Phase of Development

  1.5 Designated Orphan Status by Indication & Country

  1.6 Brand Names by Country/Region

 

Remicade Biosimilars Clinical Insight by Company

 

2. Infliximab Biosimilar – Amgen

  2.1 Clinical Insight

  2.2 Development Timeline

  2.3 Phase of Development

 

3. Infliximab Biosimilar – Axxo

  3.1 Clinical Insight

  3.2 Phase of Development

 

4. Infliximab Biosimilar – Biocad

  4.1 Clinical Insight

  4.2 Development Timeline

  4.3 Phase of Development

 

5. Infliximab Biosimilar - Bionovis/The Instituto Vital Brazil

  5.1 Clinical Insight

  5.2 Development Timeline

  5.3 Phase of Development

 

6. Infliximab Biosimilar - BioXpress Therapeutics

  6.1 Clinical Insight

  6.2 Phase of Development

 

 7. Infliximab Biosimilar – Celltrion

  7.1 Clinical Insight

  7.2 Development Timeline

  7.3 Patent Analysis

  7.4 Phase of Development

 

8. Infliximab Biosimilar – Curaxys

  8.1 Clinical Insight

  8.2 Phase of Development

 

9. Infliximab Biosimilar - Genor Biopharma

  9.1 Clinical Insight

  9.2 Development Timeline

  9.3 Phase of Development

 

10. Infliximab Biosimilar - Harvest Moon Pharmaceuticals

  10.1 Clinical Insight

  10.2 Development Timeline

  10.3 Phase of Development

 

11. Infliximab Biosimilar - LG Life Sciences

  11.1 Clinical Insight

  11.2 Phase of Development

 

12. Infliximab Biosimilar - Merck & Co/Samsung Bioepis

  12.1 Clinical Insight

  12.2 Development Timeline

  12.3 Phase of Development

 

13. Infliximab Biosimilar - Nanogen Biopharmaceutical

  13.1 Clinical Insight

  13.2 Phase of Development

 

 14. Infliximab Biosimilar - Nichiiko Pharmaceutical/Aprogen

  14.1 Clinical Insight

  14.2 Development Timeline

  14.3 Phase of Development

 

15. Infliximab Biosimilar – Pfizer

  15.1 Clinical Insight

  15.2 Development Timeline

  15.3 Phase of Development

 

16. Infliximab Biosimilar - Reliance Life Sciences

  16.1 Clinical Insight

  16.2 Development Timeline

  16.3 Phase of Development

 

17. Infliximab Biosimilar - Shanghai CP Guojian Pharmaceutical

  17.1 Clinical Insight

  17.2 Development Timeline

  17.3 Phase of Development

 

18. Infliximab Biosimilar - Therapeutic Proteins International

  18.1 Clinical Insight

  18.2 Phase of Development


Table 2-1: Amgen Infliximab Biosimilar by Indication & Phase

Table 3-1: Axxo Infliximab Biosimilar by Indication & Phase

Table 4-1: Biocad Infliximab Biosimilar by Indication & Phase

Table 5-1: Bionovis/The Instituto Vital Brazil Infliximab Biosimilar by Indiaction & Phase

Table 6-1: BioXpress Therapeutics Infliximab Biosimilar by Indication & Phase

Table 7-1: Celltrion Infliximab Biosimilar by Indication & Phase

Table 8-1: Curaxys Infliximab Biosimilar by Indication & Phase

Table 9-1: Genor Biopharma Infliximab Biosimilar by Indication & Phase

Table 10-1: Harvest Moon Pharmaceuticals Infliximab Biosimilar by Indication & Phase

Table 11-1: LG Life Sciences Infliximab Biosimilar by Indication & Phase

Table 12-1: Merck & Co/Samsung Bioepis Infliximab Biosimilar by Indication & Phase

Table 13-1: Nanogen Biopharmaceutical Infliximab Biosimilar by Indication & Phase

Table 14-1: Nichiiko Pharmaceutical/Aprogen Infliximab Biosimilar by Indication & Phase

Table 15-1: Pfizer Infliximab Biosimilar by Indication & Phase

Table 16-1: Reliance Life Sciences Infliximab Biosimilar by Indication & Phase

Table 17-1: Shanghai CP Guojian Pharmaceutical Infliximab Biosimilar by Indication & Phase

Table 18-1: Therapeutic Proteins International Infliximab Biosimilar by Indication & Phase