Enbrel Biosimilars Clinical Trial & Opportunity Insight

Publish Date:- Oct-2016      No Of Pages (70)

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“Enbrel Biosimilars Clinical Trial Insight” report by PNS Pharma gives comprehensive clinical insight on 36 biosimilars version of Enbrel drug in clinical pipeline. More than 5 of these biosimilars are in Phase-III trials and are expected to be commercially available in next 5-8 years. Currently 5 biosimilar version of Enbrel are commercially available in Iran, Mexico, India, UK and Australia. The patent on Enbrel was originally set to expire on October 23, 2012, but, in the United States, a second patent, granting exclusivity for another 16 years, has been granted.

Etanercept or Enbrel is a biopharmaceutical that has been designed to treat autoimmune diseases by interfering with Tumor necrosis factor. It is a TNF inhibitor which is made in living cell cultures rather than in a chemistry lab. It was one of the first successful products to emerge from the flourishing of innovations in cell biology since the 1990s.

 

Structurally, Enbrel (etanercept) is a dimeric fusion protein consisting of the extracellular ligand binding portion of the human 75 Kilo Dalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human immunoglobulin (IgG1). Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 Kilo Daltons.

 

Enbrel is usually indicated for treatment of moderately to severely active rheumatoid arthritis (RA) in adults. It is effective in reducing the signs and symptoms of RA, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function. It is also used for the improvement of physical function in adult patients with psoriatic arthritis (PsA). Another role of Enbrel is for the management of adult patients with chronic moderate to severe plaque psoriasis.

 

The mechanism of Enbrel includes the induction of immune response by attracting additional white blood cells to sites of inflammation and through additional molecular mechanisms which initiate and amplify inflammation. Inhibition of its action by etanercept reduces the inflammatory response which is especially useful for treating autoimmune diseases.

 

TNF receptors are found on the surface of almost all nucleated cells, it imitates the inhibitory effects of naturally occurring soluble TNF receptors, the difference being that etanercept, because it is a fusion protein rather than a simple TNF receptor, has a greatly extended half-life in the bloodstream, and therefore a more profound and long lasting biologic effect than a naturally occurring soluble TNF receptor.

 

Etanercept was developed by researchers at Immunex, and was released for commercial use in late 1998 after its FDA approval, which was the first chimeric monoclonal antibody against TNF-α to be marketed for clinical use. In North America, etanercept is co-marketed by Amgen and Pfizer under the trade name Enbrel in two separate formulations, one in powder form, and the other as a pre-mixed liquid. Wyeth was the sole marketer of Enbrel outside North America excluding Japan where Takeda Pharmaceuticals markets the drug.

 

There are some patents of Enbrel at issue include two patents owned by Hoffmann-La Roche Inc. and exclusively licensed to Immunex Corporation (U.S. Patent Nos. 8,063,182 and 8,163,522), and three patents owned by Immunex (U.S. Patent Nos. 7,915,225, 8,119,605, and 8,722,631). Immunex is a wholly owned subsidiary of Amgen Inc., and granted exclusive (sub) licenses to the patents to Amgen Manufacturing Limited, another wholly owned subsidiary of Amgen Inc.

 

The Indian pharmaceutical major Cipla made an announcement about launching the first biosimilar of Etanercept in India under the brand name 'Etacept' for the treatment of rheumatic disorders in 2013. The company's claimed that the biosimilar will cost 30% less as compared to the innovator. However, Enbrel is costly in U.S. as in 2008; the cost of Enbrel was reported to be US$ 1,500 per month or US$ 18,000 per year.By 2011, the cost had reportedly exceeded US$ 20,000 per year.Enbrel is more expensive in the U.S. than in other countries.

 


“Enbrel Biosimilars Clinical Trial Insight” report by PNS Pharma gives comprehensive clinical insight on 36 biosimilars version of Enbrel drug in clinical pipeline. More than 5 of these biosimilars are in Phase-III trials and are expected to be commercially available in next 5-8 years. Currently 5 biosimilar version of Enbrel are commercially available in Iran, Mexico, India, UK and Australia. The patent on Enbrel was originally set to expire on October 23, 2012, but, in the United States, a second patent, granting exclusivity for another 16 years, has been granted.

Etanercept or Enbrel is a biopharmaceutical that has been designed to treat autoimmune diseases by interfering with Tumor necrosis factor. It is a TNF inhibitor which is made in living cell cultures rather than in a chemistry lab. It was one of the first successful products to emerge from the flourishing of innovations in cell biology since the 1990s.

 

Structurally, Enbrel (etanercept) is a dimeric fusion protein consisting of the extracellular ligand binding portion of the human 75 Kilo Dalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human immunoglobulin (IgG1). Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has an apparent molecular weight of approximately 150 Kilo Daltons.

 

Enbrel is usually indicated for treatment of moderately to severely active rheumatoid arthritis (RA) in adults. It is effective in reducing the signs and symptoms of RA, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function. It is also used for the improvement of physical function in adult patients with psoriatic arthritis (PsA). Another role of Enbrel is for the management of adult patients with chronic moderate to severe plaque psoriasis.

 

The mechanism of Enbrel includes the induction of immune response by attracting additional white blood cells to sites of inflammation and through additional molecular mechanisms which initiate and amplify inflammation. Inhibition of its action by etanercept reduces the inflammatory response which is especially useful for treating autoimmune diseases.

 

TNF receptors are found on the surface of almost all nucleated cells, it imitates the inhibitory effects of naturally occurring soluble TNF receptors, the difference being that etanercept, because it is a fusion protein rather than a simple TNF receptor, has a greatly extended half-life in the bloodstream, and therefore a more profound and long lasting biologic effect than a naturally occurring soluble TNF receptor.

 

Etanercept was developed by researchers at Immunex, and was released for commercial use in late 1998 after its FDA approval, which was the first chimeric monoclonal antibody against TNF-α to be marketed for clinical use. In North America, etanercept is co-marketed by Amgen and Pfizer under the trade name Enbrel in two separate formulations, one in powder form, and the other as a pre-mixed liquid. Wyeth was the sole marketer of Enbrel outside North America excluding Japan where Takeda Pharmaceuticals markets the drug.

 

There are some patents of Enbrel at issue include two patents owned by Hoffmann-La Roche Inc. and exclusively licensed to Immunex Corporation (U.S. Patent Nos. 8,063,182 and 8,163,522), and three patents owned by Immunex (U.S. Patent Nos. 7,915,225, 8,119,605, and 8,722,631). Immunex is a wholly owned subsidiary of Amgen Inc., and granted exclusive (sub) licenses to the patents to Amgen Manufacturing Limited, another wholly owned subsidiary of Amgen Inc.

 

The Indian pharmaceutical major Cipla made an announcement about launching the first biosimilar of Etanercept in India under the brand name 'Etacept' for the treatment of rheumatic disorders in 2013. The company's claimed that the biosimilar will cost 30% less as compared to the innovator. However, Enbrel is costly in U.S. as in 2008; the cost of Enbrel was reported to be US$ 1,500 per month or US$ 18,000 per year.By 2011, the cost had reportedly exceeded US$ 20,000 per year.Enbrel is more expensive in the U.S. than in other countries.

 

1. Enbrel (Etanercept) Clinical Insight

  1.1 Clinical Introduction

  1.2 Company Partnerships & Agreements

  1.3 Patent Analysis by Indication

  1.4 Brand Names by Country/Region

 

Enbrel Biosimilars Clinical Insight by Company

 

2. Etanercept Biosimilar - Neurokine Pharmaceuticals

  2.1 Clinical Insight

  2.2 Development Timeline

  2.3 Patent Analysis

  2.4 Phase of Development

 

3. Etanercept Biosimilar - Alteogen/Cristalia

  3.1 Clinical Insight

  3.2 Development Timeline

  3.3 Phase of Development

 

4. Etanercept Biosimilar - Amega Biotech

  4.1 Clinical Insight

  4.2 Phase of Development

 

5. Etanercept Biosimilar - AryoGen Biopharma

  5.1 Clinical Insight

  5.2 Phase of Development

 

6. Etanercept Biosimilar - AvesthaGen

  6.1 Clinical Insight

  6.2 Development Timeline

  6.3 Patent Analysis

  6.4 Phase of Development

 

 7. Etanercept Biosimilar - Axxo

  7.1 Clinical Insight

  7.2 Phase of Development

 

8. Etanercept Biosimilar - Bio Sidus S.A

  8.1 Clinical Insight

  8.2 Phase of Development

 

9. Etanercept Biosimilar - Biocon/Mylan

  9.1 Clinical Insight

  9.2 Phase of Development

 

10. Etanercept Biosimilar - Bionovis/The Instituto Vital Brazil

  10.1 Clinical Insight

  10.2 Development Timeline

  10.3 Phase of Development

 

11. Etanercept Biosimilar - Biotrion

  11.1 Clinical Insight

  11.2 Phase of Development

 

12. Etanercept Biosimilar - BioXpress Therapeutics

  12.1 Clinical Insight

  12.2 Phase of Development

 

13. Etanercept Biosimilar - Celltrion

  13.1 Clinical Insight

  13.2 Phase of Development

 

14. Etanercept Biosimilar - Clover Biopharmaceuticals

  14.1 Clinical Insight

  14.2 Phase of Development

 

15. Etanercept Biosimilar - Coherus Biosciences

  15.1 Clinical Insight

  15.2 Development Timeline

  15.3 Phase of Development

 

16. Etanercept Biosimilar - Daewoong Pharmaceutical

  16.1 Clinical Insight

  16.2 Development Timeline

  16.3 Phase of Development

 

17. Etanercept Biosimilar - Dong-A ST/Meiji Seika Pharma

  17.1 Clinical Insight

  17.2 Phase of Development

 

18. Etanercept Biosimilar - Hanwha Chemical

  18.1 Clinical Insight

  18.2 Development Timeline

  18.3 Phase of Development

 

19. Etanercept Biosimilar - Harvest Moon Pharmaceuticals

  19.1 Clinical Phase

  19.2 Development Timeline

  19.3 Phase of Development

 

20. Etanercept Biosimilar - Hisun-Pfizer Pharmaceuticals

  20.1 Clinical Insight

  20.2 Development Timeline

  20.3 Phase of Development

 

21. Etanercept Biosimilar - Intas Biopharmaceuticals

  21.1 Clinical Insight

  21.2 Development Timeline

  21.3 Phase of Development

 

22. Etanercept Biosimilar - LG Life Sciences

  22.1 Clinical Insight

  22.2 Development Timeline

  22.3 Phase of Development

 

 23. Etanercept Biosimilar - mAbxience

  23.1 Clinical Insight

  23.2 Development Timeline

  23.3 Phase of Development

 

24. Etanercept Biosimilar - Mycenax Biotech/TSH Biopharm

  24.1 Clinical Insight

  24.2 Development Timeline

  24.3 Phase of Development

 

25. Etanercept Biosimilar - Nanogen Biopharmaceutical

  25.1 Clinical Insight

  25.2 Phase of Development

 

26. Etanercept Biosimilar - PROBIOMED

  26.1 Clinical Insight

  26.2 Development Timeline

  26.3 Phase of Development

 

27. Etanercept Biosimilar - Qilu Pharmacetuical

  27.1 Clinical Insight

  27.2 Development Timeline

  27.3 Phase of Development

 

28. Etanercept Biosimilar - Reliance Life Sciences

  28.1 Clinical Insight

  28.2 Development Timeline

  28.3 Phase of Development

 

29. Etanercept Biosimilar - Samsung Bioepis/Merck & Co

  29.1 Clinical Insight

  29.2 Development Timeline

  29.3 Phase of Development

 

 30. Etanercept Biosimilar - Sandoz

  30.1 Clinical Insight

  30.2 Development Timeline

  30.3 Phase of Development

 

31. Etanercept Biosimilar - Shanghai Celgen

  31.1 Clinical Insight

  31.2 Development Timeline

  31.3 Phase of Development

 

32. Etanercept Biosimilar - Shanghai CP Guojian Pharmaceutical

  32.1 Clinical Insight

  32.2 Development Timeline

  32.3 Phase of Development

 

33. Etanercept Biosimilar - Shanghai Fudan-Zhangjiang Bio-Pharmaceutical

  33.1 Clinical Insight

  33.2 Development Timeline

  33.3 Phase of Development

 

34. Etanercept Biosimilar - STC Biologics

  34.1 Clinical Insight

  34.2 Development Timeline

  34.3 Phase of Development

 

35. Etanercept Biosimilar - Therapeutic Proteins International

  35.1 Clinical Insight

  35.2 Phase of Development

 

36. Etanercept Biosimilar - YL Biologics

  36.1 Clinical Inisight

  36.2 Development Timeline

  36.3 Phase of Development

 

 37. Etanercept Liposomal - Neurokine Pharmaceuticals

  37.1 Clinical Insight

  37.2 Phase of Development


Table 2-1: Neurokine Pharmaceuticals Etanercept Biosimilar by Indication & Phase

Table 3-1: Alteogen/Cristalia Etanercept Biosimilar by Indication & Phase

Table 4-1: Amega Biotech Etanercept Biosimilar by Inidcation & Phase

Table 5-1: AryoGen Biopharma Etanercept Biosimilar by Indication & Phase

Table 6-1: AvesthaGen Etanercept Biosimilar by Indication & Phase

Table 7-1: Axxo Etanercept Biosimilar by Indication & Phase

Table 8-1: Bio Sidus S.A Etanercept Biosimilar by Indication & Phase

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

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

Table 11-1: Biotrion Etanercept Biosimilar by Indication & Phase

Table 12-1: BioXpress Therapeutics Etanercept Biosimilar by Indication & Phase

Table 13-1: Celltrion Etanercept Biosimilar by Indication & Phase

Table 14-1: Clover Biopharmaceuticals Etanercept Biosimilar by Indication & Phase

Table 15-1: Coherus Biosciences Etanercept Biosimilar by Indication & Phase

Table 16-1: Daewoong Pharmaceutical Etanercept Biosimilar by Indication & Phase

Table 17-1: Dong-A ST/Meiji Seika Pharma Etanercept Biosimilar by Indication & Phase

Table 18-1: Hanwha Chemical Etanercept Biosimilar by Indication & Phase

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

Table 20-1: Hisun-Pfizer Pharmaceuticals Etanercept Biosimilar by Indication & Phase

Table 21-1: Intas Biopharmaceuticals Etanercept Biosimilar by Indication & Phase

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

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

Table 24-1: Mycenax Biotech/TSH Biopharm Etanercept Biosimilar by Indication & Phase

Table 25-1: Nanogen Biopharmaceutical Etanercept Biosimilar by Indication & Phase

Table 26-1: PROBIOMED Etanercept Biosimilar by Indication & Phase

Table 27-1: Qilu Pharmacetuical Etanercept Biosimilar by Indication & Phase

Table 28-1: Reliance Life Sciences Etanercept Biosimilar by Indication & Phase

Table 29-1: Samsung Bioepis/Merck & Co Etanercept Biosimilar by Indication & Phase

Table 30-1: Sandoz Etanercept Biosimilar by Indication & Phase

Table 31-1: Shanghai Celgen Etanercept Biosimilar by Indication & Phase

Table 32-1: Shanghai CP Guojian Pharmaceutical Etanercept Biosimilar by Indication & Phase

Table 33-1: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Etanercept Biosimilar by Indication & Phase

Table 34-1: STC Biologics Etanercept Biosimilar by Indication & Phase

Table 35-1: Therapeutic Proteins International Etanercept Biosimilar by Indication & Phase

Table 36-1: YL Biologics Etanercept Biosimilar by Indication & Phase

Table 37-1: Neurokine Pharmaceuticals Etanercept Liposomal by Indication & Phase