Humira Biosimilars Clinical Trial Insight

Publish Date:- Oct-2016      No Of Pages (80)

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“Humira Biosimilars Clinical Trial Insight” report by PNS Pharma gives comprehensive clinical insight on 33 biosimilars version of Humira drug in clinical pipeline. More than 10 of these biosimilars are in Phase-III trials and are expected to be commercially available in next 5-8 years. The patent protection assigned to Humira will expire in 2016 for US and 2018 for European market.

                                                                                      

The Humira stands for Human Monoclonal Antibody in Rheumatoid Arthritis. It is also termed as Adalimumab or D2E7 and is a recombinant Immunoglobulin G1 monoclonal antibody which is specific for tumor necrosis factor alpha (TNF-α). It is a drug designed by the mode of recombinant DNA technology for the treatment of rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. In the rheumatoid arthritis adalimumab has the equivalent efficacy as that of methotrexate.

 

The chemical and biological components of Humira define it as a TNF inhibiting anti-inflammatory biologic medication. It binds to the TNF-α which leads to the inflammatory response of autoimmune diseases but after the conjugation of Humira it reduces the inflammatory response.

 

The mechanism of action includes the binding of HUMIRA specifically to TNF-α and renders it, incapable of binding to its receptors on cell surfaces. TNF-α exerts its pro-inflammatory role by binding to its cell surface receptor. When HUMIRA binds to the membrane bound version of TNF-α on TNF-α-producing cells, it can lead to lysis of these TNF-α producing cell in the presence of complement.

 

TNF- α level is found elevated in the synovial fluids of rheumatoid arthritis. TNF-α is one of the important factors that contribute to the pathology and perpetuation of the inflamed and destroyed joints in rheumatoid arthritis. Given that rheumatoid arthritis is a complex disease with multiple factors involved, the ability for a monoclonal antibody to neutralize the function of one single cytokine TNF-α and greatly improve the symptoms and progression of rheumatoid arthritis.

 

It is produced by Abbot Laboratories but originally Humira was emerged from collaboration between Bioresearch Center in Massachusetts (BASF) and the Cambridge Antibody Technologies in the UK.  Mid stage clinical trials were so promising that, at the end of 2000, Abbott agreed to buy the BASF Bioresearch Center for US$ 6.9 Billion.  When Humira was launched in 2003, it was the third TNF-alpha antibody to the market. Its US, FDA approval for marketing was achieved on December 31, 2002. In 2012 to 2015 Humira topped the top selling pharmaceutical product lists and in 2015, Humira had topped US$ 14 Billion of sales globally.

 

However, its superior dosing schedule and improved toleration over existing therapy enabled it to become the best in class agent.  Furthermore, Abbott had a robust development program for Humira and expanded its use to other inflammatory disease such as psoriasis, Crohn’s disease, and juvenile idiopathic arthritis.  While prescribed to far fewer patients than Lipitor, the high cost of this biological medicine is such that Humira’s sales were projected to exceed US$ 9 Billion.

 

In December 2014, Indian drug maker Cadila Healthcare declared the launch of the first adalimumab biosimilar at a fifth of its U.S. price. The generic has been launched under the brand name Exemptia. In January 2016, another Indian drug maker Torrent Pharmaceuticals launched its biosimilar for adalimumab. Torrent's Adfrar would be the second generic biosimilar of adalimumab in the world. In September 2016 the US FDA approved Amgens biosimilar adalimumab-atto sold under the brand name Amjevita.


“Humira Biosimilars Clinical Trial Insight” report by PNS Pharma gives comprehensive clinical insight on 33 biosimilars version of Humira drug in clinical pipeline. More than 10 of these biosimilars are in Phase-III trials and are expected to be commercially available in next 5-8 years. The patent protection assigned to Humira will expire in 2016 for US and 2018 for European market.

                                                                                      

The Humira stands for Human Monoclonal Antibody in Rheumatoid Arthritis. It is also termed as Adalimumab or D2E7 and is a recombinant Immunoglobulin G1 monoclonal antibody which is specific for tumor necrosis factor alpha (TNF-α). It is a drug designed by the mode of recombinant DNA technology for the treatment of rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. In the rheumatoid arthritis adalimumab has the equivalent efficacy as that of methotrexate.

 

The chemical and biological components of Humira define it as a TNF inhibiting anti-inflammatory biologic medication. It binds to the TNF-α which leads to the inflammatory response of autoimmune diseases but after the conjugation of Humira it reduces the inflammatory response.

 

The mechanism of action includes the binding of HUMIRA specifically to TNF-α and renders it, incapable of binding to its receptors on cell surfaces. TNF-α exerts its pro-inflammatory role by binding to its cell surface receptor. When HUMIRA binds to the membrane bound version of TNF-α on TNF-α-producing cells, it can lead to lysis of these TNF-α producing cell in the presence of complement.

 

TNF- α level is found elevated in the synovial fluids of rheumatoid arthritis. TNF-α is one of the important factors that contribute to the pathology and perpetuation of the inflamed and destroyed joints in rheumatoid arthritis. Given that rheumatoid arthritis is a complex disease with multiple factors involved, the ability for a monoclonal antibody to neutralize the function of one single cytokine TNF-α and greatly improve the symptoms and progression of rheumatoid arthritis.

 

It is produced by Abbot Laboratories but originally Humira was emerged from collaboration between Bioresearch Center in Massachusetts (BASF) and the Cambridge Antibody Technologies in the UK.  Mid stage clinical trials were so promising that, at the end of 2000, Abbott agreed to buy the BASF Bioresearch Center for US$ 6.9 Billion.  When Humira was launched in 2003, it was the third TNF-alpha antibody to the market. Its US, FDA approval for marketing was achieved on December 31, 2002. In 2012 to 2015 Humira topped the top selling pharmaceutical product lists and in 2015, Humira had topped US$ 14 Billion of sales globally.

 

However, its superior dosing schedule and improved toleration over existing therapy enabled it to become the best in class agent.  Furthermore, Abbott had a robust development program for Humira and expanded its use to other inflammatory disease such as psoriasis, Crohn’s disease, and juvenile idiopathic arthritis.  While prescribed to far fewer patients than Lipitor, the high cost of this biological medicine is such that Humira’s sales were projected to exceed US$ 9 Billion.

 

In December 2014, Indian drug maker Cadila Healthcare declared the launch of the first adalimumab biosimilar at a fifth of its U.S. price. The generic has been launched under the brand name Exemptia. In January 2016, another Indian drug maker Torrent Pharmaceuticals launched its biosimilar for adalimumab. Torrent's Adfrar would be the second generic biosimilar of adalimumab in the world. In September 2016 the US FDA approved Amgens biosimilar adalimumab-atto sold under the brand name Amjevita.

1. Humira (Adalimumab) Clinical Insight

  1.1 Clinical Introduction

  1.2 Company Partnerships & Agreements

  1.3 Patent Analysis by Indication

  1.4 Designated Orphan Status by Indication & Country

  1.5 Brand Names by Country/Region

 

Humira Biosimilars Clinical Insight by Company

 

2. Adalimumab Biosimilar - AET BioTech/BioXpress Therapeutics

  2.1 Clinical Insight

  2.2 Development Timeline

  2.3 Phase of Development

 

3. Adalimumab Biosimilar - Alphamab

  3.1 Clinical Insight

  3.2 Development Timeline

  3.3 Phase of Development

 

4. Adalimumab Biosimilar - Alteogen/Cristalia

  4.1 Clinical Insight

  4.2 Phase of Development

 

5. Adalimumab Biosimilar - Amgen

  5.1 Clinical Insight

  5.2 Development Timeline

  5.3 Phase of Development

 

6. Adalimumab Biosimilar - Axxo

  6.1 Clinical Insight

  6.2 Phase of Development

 

 7. Adalimumab Biosimilar - Biocad

  7.1 Clinical Insight

  7.2 Development Timeline

  7.3 Phase of Development

 

8. Adalimumab Biosimilar - BIOCND/Genor Biopharma

  8.1 Clinical Insight

  8.2 Development Timeline

  8.3 Phase of Development

 

9. Adalimumab Biosimilar - Biocon/Mylan

  9.1 Clinical Insight

  9.2 Development Timeline

  9.3 Phase of Development

 

10. Adalimumab Biosimilar - Bionovis/The Instituto Vital Brazil

  10.1 Clinical Insight

  10.2 Development Timeline

  10.3 Phase of Development

 

11. Adalimumab Biosimilar - Boehringer Ingelheim

  11.1 Clinical Insight

  11.2 Development Timeline

  11.3 Phase of Development

 

12. Adalimumab Biosimilar - Celltrion

  12.1 Clinical Insight

  12.2 Phase of Development

 

13. Adalimumab Biosimilar - CinnaGen

  13.1 Clinical Insight

  13.2 Phase of Development

 

 14. Adalimumab Biosimilar - Coherus BioSciences

  14.1 Clinical Insight

  14.2 Development Timeline

  14.3 Phase of Development

 

15. Adalimumab Biosimilar - Dong A ST/Meiji Seika Pharma

  15.1 Clinical Insight

  15.2 Development Timeline

  15.3 Phase of Development

 

16. Adalimumab Biosimilar - EMD Serono/Merck

  16.1 Clinical Insight

  16.2 Development Timeline

  16.3 Phase of Development

 

17. Adalimumab Biosimilar - Fujifilm Kyowa Kirin Biologics

  17.1 Clinical Insight

  17.2 Development Timeline

  17.3 Phase of Development

 

18. Adalimumab Biosimilar - Gene Techno Science

  18.1 Clinical Insight

  18.2 Phase of Development

 

19. Adalimumab Biosimilar - Harvest Moon Pharmaceuticals

  19.1 Clinical Insight

  19.2 Development Timeline

  19.3 Phase of Development

 

20. Adalimumab Biosimilar - Hetero Drugs

  20.1 Clinical Insight

  20.2 Development Timeline

  20.3 Phase of Development

 

 21. Adalimumab Biosimilar - Innovent Biologics

  21.1 Clinical Insight

  21.2 Development Timeline

  21.3 Phase of Development

 

22. Adalimumab Biosimilar - LG Life Sciences

  22.1 Clinical Insight

  22.2 Development Timeline

  22.3 Phase of Development

 

23. Adalimumab Biosimilar - mAbxience

  23.1 Clinical Insight

  23.2 Development Timeline

  23.3 Phase of Development

 

24. Adalimumab Biosimilar - Meridian Biopharmaceuticals

  24.1 Clinical Insight

  24.2 Phase of Development

 

25. Adalimumab Biosimilar - Momenta Pharmaceuticals

  25.1 Clinical Insight

  25.2 Development Timeline

  25.3 Phase of Development

 

26. Adalimumab Biosimilar - Oncobiologics

  26.1 Clinical Insight

  26.2 Development Timeline

  26.3 Phase of Development

 

27. Adalimumab Biosimilar - Pfizer

  27.1 Clinical Insight

  27.2 Development Timeline

  27.3 Phase of Development

 

 28. Adalimumab Biosimilar - PlantPraxis

  28.1 Clinical Insight

  28.2 Development Timeline

  28.3 Phase of Development

 

29. Adalimumab Biosimilar - Reliance Life Sciences

  29.1 Clinical Insight

  29.2 Development Timeline

  29.3 Phase of Development

 

30. Adalimumab Biosimilar - Samsung Bioepis

  30.1 Clinical Insight

  30.2 Development Timeline

  30.3 Phase of Development

 

31. Adalimumab Biosimilar - Sandoz

  31.1 Clinical Insight

  31.2 Development Timeline

  31.3 Phase of Development

 

32. Adalimumab Biosimilar - Shanghai Henlius Biotech

  32.1 Clinical Insight

  32.2 Development Timeline

  32.3 Phase of Development

 

33. Adalimumab Biosimilar - Therapeutic Proteins International

  33.1 Clinical Insight

  33.2 Phase of Development

 

34. Adalimumab Biosimilar - Zydus Cadila

  34.1 Clinical Insight

  34.2 Development Timeline

  34.3 Phase of Development

 

 35. Patent Litigation Issues Involving Development of Humira (Adalimumab) Biosimilar

  35.1 Amgen v/s AbbVie

  35.2 Coherus v/s AbbVie


Table 1-1: Humira Clinical Trial by Phase of Development

Table 1-2: Humira - Designated Orphan Status by Indication & Country

Table 1-3: Humira - Brand Names by Country/Region

Table 2-1: AET BioTech/BioXpress Therapeutics Adalimumab Biosimilar by Indication & Phase

Table 3-1: Alphamab Adalimumab Biosimilar by Indication & Phase

Table 4-1: Alteogen/Cristalia Adalimumab Biosimilar by Indication & Phase

Table 5-1: Amgen Adalimumab Biosimilar by Indication & Phase

Table 6-1: Axxo Adalimumab Biosimilar by Indication & Phase

Table 7-1 Biocad Adalimumab Biosimilar by Indication & Phase

Table 8-1: BIOCND/Genor Biopharma Adalimumab Biosimilar by Indication & Phase

Table 9-1: Biocon/Mylan Adalimumab Biosimilar by Indication & Phase

Table 10-1: Bionovis/The Instituto Vital Brazil Adalimumab Biosimilar  by Indication & Phase

Table 11-1: Boehringer Ingelheim Adalimumab Biosimilar  by Indication & Phase

Table 12-1: Celltrion Adalimumab Biosimilar  by Indication & Phase

Table 13-1: CinnaGen Adalimumab Biosimilar  by Indication & Phase

Table 14-1: Coherus BioSciences Adalimumab Biosimilar  by Indication & Phase

Table 15-1: Dong A ST/Meiji Seika Pharma Adalimumab Biosimilar  by Indication & Phase

Table 16-1: EMD Serono/Merck Adalimumab Biosimilar by Indication & Phase

Table 17-1: Fujifilm Kyowa Kirin Biologics Adalimumab Biosimilar by Indication & Phase

Table 18-1: Gene Techno Science Adalimumab Biosimilar by Indication & Phase

Table 19-1: Harvest Moon Pharmaceuticals Adalimumab Biosimilar by Indication & Phase

Table 20-1: Hetero Drugs Adalimumab Biosimilar by Indication & Phase

Table 21-1: Innovent Biologics Adalimumab Biosimilar by Indication & Phase

Table 22-1: LG Life Sciences Adalimumab Biosimilar  by Indication & Phase

Table 23-1: mAbxience Adalimumab Biosimilar by Indication & Phase

Table 24-1: Meridian Biopharmaceuticals Adalimumab Biosimilar by Indication & Phase

Table 25-1: Momenta Pharmaceuticals Adalimumab Biosimilar by Indication & Phase

Table 26-1: Oncobiologics Adalimumab Biosimilar by Indication & Phase

Table 27-1: Pfizer Adalimumab Biosimilar by Indication & Phase

Table 28-1: PlantPraxis Adalimumab Biosimilar by Indication & Phase

Table 29-1: Reliance Life Sciences Adalimumab Biosimilar by Indication & Phase

Table 30-1: Samsung Bioepis Adalimumab Biosimilar by Indication & Phase

Table 31-1: Sandoz Adalimumab Biosimilar by Indication & Phase

Table 32-1: Shanghai Henlius Biotech Adalimumab Biosimilar by Indication & Phase

Table 33-1: Therapeutic Proteins International Adalimumab Biosimilar by Indication & Phase

Table 34-1: Zydus Cadila Adalimumab Biosimilar by Indication & Phase