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Market Research Report

Enbrel Biosimilars Clinical Trial Insight

Published by PNS Pharma Product code 374505
Published Content info 70 Pages
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Enbrel Biosimilars Clinical Trial Insight
Published: October 17, 2016 Content info: 70 Pages
Description

"Enbrel Biosimilars Clinical Trial Insight" report by PNS Pharma gives comprehensive clinical insight on 36 biosimilar 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 (2028), 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.

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 2016, the cost had reportedly exceeded US$ 24,000 per year (US$ 2183 Per Month).

Table of Contents

Table of Contents

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

List of Tables

  • 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
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