Herceptin (Trastuzumab) Biosimilar Clinical Trial Insight

  • ID: 3927853
  • Clinical Trials
  • Region: Global
  • 85 Pages
  • PNS Pharma
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Herceptin, One of Roche's Three Her2+ Breast Cancer Drugs, Recorded a 15% Sales Increase in the US and a 10% Rise Overall

FEATURED COMPANIES

  • Allergan/Amgen
  • Biocad
  • Celltrion
  • Glycotope
  • Mabion
  • Paras Biopharmaceuticals
  • MORE

The “Herceptin (Trastuzumab) Biosimilar Clinical Trial Insight” report gives comprehensive clinical insight on 37 biosimilar version of Herceptin drug in clinical pipeline. Currently there are 4 biosimilars in Phase-III trials and are expected to be commercially available in next 5-8 years. Currently 3 biosimilar version of Herceptin are commercially available in India and Iran for the treatment of Breast cancer. The patent on Herceptin expired in 2014.

Trastuzumab or Herceptin is a recombinant DNA derived humanized monoclonal antibody that interferes with the HER2/Neu receptor. It is the most common biological therapy used particularly for breast cancer, against the Her2+ receptor which stands for Human Epidermal Growth Factor Receptor 2-positive. In some cancers, notably certain types of breast cancer, HER2 is over-expressed, and causes cancer cells to reproduce uncontrollably.

Herceptin as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease. Herceptin in combination with paclitaxel is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy for their metastatic disease.

The mechanism of action of this drug is observed clearly in Breast cancer, as HER 2 is overexpressed allowing the cell proliferation in uncontrolled manner. The trastuzumab binds to the domain IV of the extracellular segment of HER2/Neu receptor and the drug causes the arrest during G1 phase of cycle, thus reduced proliferation and moreover, it down regulates the activation of AKT pathway too thus ending the uncontrolled cell differentiation.

Herceptin, one of Roche's three HER2+ breast cancer drugs, recorded a 15% sales increase in the US and a 10% rise overall. Sales were driven by longer duration of treatment in combination with Perjeta, another HER2+ breast cancer treatment from Roche, for both early and advanced breast cancer. China and Brazil also contributed to strong growth in Herceptin sales.

It costs around US$ 70,000 for full course treatment, thus allowing the big blockbuster for Roche with the sales of US$ 6.79 Billion in 2015; it is the drug that remained third best seller after about 15 years on the market. Roche has changed the trade name of the drug and has re-introduced an affordable version of the same in the Indian market. The new drug named Herclon would cost approximately INR  75,000 (US$ 1122) in the Indian market.

Biocon Limited, a pharmaceutical in India had received Marketing Authorization from the Drugs Controller General of India (DCGI) for its biosimilar Trastuzumab being developed jointly with Mylan, for the treatment of Her 2+ metastatic breast cancer. The regulatory approval for biosimilar Trastuzumab in India is the world’s first biosimilar version under the brand name of CANMAb.

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FEATURED COMPANIES

  • Allergan/Amgen
  • Biocad
  • Celltrion
  • Glycotope
  • Mabion
  • Paras Biopharmaceuticals
  • MORE

1. Herceptin (Trastuzumab) Clinical Insight
1.1 Clinical Introduction
1.2 Company Partnerships & Agreements
1.3 Patent Analysis by Indication
1.4 Brand Names by Country/Region

Herceptin Biosimilars Clinical Insight by Company

2. BOW 040
2.1 Clinical Insight
2.2 Development Timeline
2.3 Phase of Development

3. Trastuzumab Biosimilar - ISU Abxis
3.1 Clinical Insight
3.2 Development Timeline
3.3 Phase of Development

4. Trastuzumab Biosimilar - Allergan/Amgen
4.1 Clinical Insight
4.2 Development Timeline
4.3 Phase of Development

5. Trastuzumab Biosimilar - Alteogen/Cristalia
5.1 Clinical Insight
5.2 Development Timeline
5.3 Phase of Development

6. Trastuzumab Biosimilar - AryoGen Biopharma
6.1 Clinical Insight
6.2 Development Timeline
6.3 Phase of Development

7. Trastuzumab Biosimilar - Axxo
7.1 Clinical Insight
7.2 Phase of Development

8. Trastuzumab Biosimilar - Biocad
8.1 Clinical Insight
8.2 Development Timeline
8.3 Patent Analysis

9. Trastuzumab Biosimilar - BIOCND/Genor Biopharma
9.1 Clinical Insight
9.2 Development Timeline
9.3 Phase of Development

10. Trastuzumab Biosimilar - Biocon/Mylan
10.1 Clinical Insight
10.2 Development Timeline
10.3 Patent Analysis
10.4 Phase of Development

11. Trastuzumab Biosimilar - Bionovis/The Instituto Vital Brazil
11.1 Clinical Insight
11.2 Development Timeline
11.3 Phase of Development

12. Trastuzumab Biosimilar - BioXpress Therapeutics
12.1 Clinical Insight
12.2 Phase of Development

13. Trastuzumab Biosimilar - Celltrion
13.1 Clinical Insight
13.2 Development Timeline
13.3 Phase of Development

14. Trastuzumab Biosimilar - Curaxys
14.1 Clinical Insight
14.2 Phase of Development

15. Trastuzumab Biosimilar - Dong-A ST/Meiji Seika Pharma
15.1 Clinical Insight
15.2 Development Timeline
15.3 Phase of Development

16. Trastuzumab Biosimilar - Dr. Reddy's Laboratories
16.1 Clinical Insight
16.2 Development Timeline
16.3 Phase of Development

17. Trastuzumab Biosimilar - Gedeon Richter
17.1 Clinical Insight
17.2 Phase of Development

18. Trastuzumab Biosimilar - Hanwha Biologics
18.1 Clinical Insight
18.2 Phase of Development

19. Trastuzumab Biosimilar - Harvest Moon Pharmaceuticals
19.1 Clinical Insight
19.2 Development Timeline
19.3 Phase of Development

20. Trastuzumab Biosimilar - Hetero Drugs
20.1 Clinical Insight
20.2 Development Timeline
20.3 Phase of Development

21. Trastuzumab Biosimilar - International Biotech Center Generium
21.1 Clinical Insight
21.2 Phase of Development

22. Trastuzumab Biosimilar - Mabion
22.1 Clinical Insight
22.2 Development Timeline
22.3 Phase of Development

23. Trastuzumab Biosimilar - mAbxience
23.1 Clinical Insight
23.2 Development Timeline
23.3 Phase of Development

24. Trastuzumab Biosimilar - Nanogen Biopharmaceutical
24.1 Clinical Insight
24.2 Phase of Development

25. Trastuzumab Biosimilar - Nichi-Iko Pharmaceutical/Aprogen
25.1 Clinical Insight
25.2 Development Timeline
25.3 Phase of Development

26. Trastuzumab Biosimilar - Oncobiologics
26.1 Clinical Insight
26.2 Development Timeline
26.3 Phase of Development

27. Trastuzumab Biosimilar - Paras Biopharmaceuticals
27.1 Clinical Insight
27.2 Phase of Development

28. Trastuzumab Biosimilar - Pfizer
28.1 Clinical Insight
28.2 Development Timeline
28.3 Phase of Development

29. Trastuzumab Biosimilar - PlantForm Corporation
29.1 Clinical Insight
29.2 Development Timeline
29.3 Patent Analysis
29.4 Phase of Development

30. Trastuzumab Biosimilar - Polpharma
30.1 Clinical Insight
30.2 Phase of Development

31. Trastuzumab Biosimilar - ProBioGen AG/Bio Farma Indonesia
31.1 Clinical Insight
31.2 Phase of Development

32. Trastuzumab Biosimilar - Reliance Life Sciences
32.1 Clinical Insight
32.2 Development Timeline
32.3 Phase of Development

33. Trastuzumab Biosimilar - Samsung Bioepis
33.1 Clinical Insight
33.2 Development Timeline
33.3 Phase of Development

34. Trastuzumab Biosimilar - Shanghai CP Guojian Pharmaceutical
34.1 Clinical Insight
34.2 Development Timeline
34.3 Phase of Development

35. Trastuzumab Biosimilar - Shanghai Henlius Biotech
35.1 Clinical Insight
35.2 Development Timeline
35.3 Phase of Development

36. Trastuzumab Biosimilar - STC Biologics
36.1 Clinical Insight
36.2 Development Timeline
36.3 Phase of Development

37. Trastuzumab Biosimilar - Therapeutic Proteins International
37.1 Clinical Insight
37.2 Phase of Development

38. Trastuzumab Biosimilar - Zydus
38.1 Clinical Insight
38.2 Development Timeline
38.3 Phase of Development

39. Trastuzumab Glyco-optimised - Glycotope
39.1 Development Timeline
39.2 Phase of Development

40. Trastuzumab Subcutaneous
40.1 Clinical Insight
40.2 Development Timeline
40.3 Patent Analysis
40.4 Phase of Development

List of Tables:
Table 2-1: EPIRUS Biopharmaceuticals BOW 040 Biosimilar by Indication & phase
Table 3-1: ISU Abxis Trastuzumab Biosimilar by Indication & Phase
Table 4-1: Allergan/Amgen Trastuzumab Biosimilar by Indication & Phase
Table 5-1: Alteogen/Cristalia Trastuzumab Biosimilar by Indication & Phase
Table 6-1: AryoGen Biopharma Trastuzumab Biosimilar by Indication & Phase
Table 7-1: Axxo Trastuzumab Biosimilar by Indication & Phase
Table 9-1: BIOCND/Genor Biopharma Trastuzumab Biosimilar by Indication & Phase
Table 10-1: Biocon/Mylan Trastuzumab Biosimilar by Indication & Phase
Table 11-1: Bionovis/The Instituto Vital Brazil Trastuzumab Biosimilar by Indication & Phase
Table 12-1: BioXpress Therapeutics Trastuzumab Biosimilar by Indication & Phase
Table 13-1: Celltrion Trastuzumab Biosimilar by Indication & Phase
Table 14-1: Curaxys Trastuzumab Biosimilar by Indication & Phase
Table 15-1: Dong-A ST/Meiji Seika Pharma Trastuzumab Biosimilar by Indication & Phase
Table 16-1: Dr. Reddy's Laboratories Trastuzumab Biosimilar by Indication & Phase
Table 17-1: Gedeon Richter Trastuzumab Biosimilar by Indication & Phase
Table 18-1: Hanwha Biologics Trastuzumab Biosimilar by Indication & Phase
Table 19-1: Harvest Moon Pharmaceuticals Trastuzumab Biosimilar by Indication & Phase
Table 20-1: Hetero Drugs Trastuzumab Biosimilar by Indication & Phase
Table 21-1: International Biotech Center Generium Trastuzumab Biosimilar by Indication & Phase
Table 22-1: Mabion Trastuzumab Biosimilar by Indication & Phase
Table 23-1: mAbxience Trastuzumab Biosimilar by Indication & Phase
Table 24-1: Nanogen Biopharmaceutical Trastuzumab Biosimilar by Indication & Phase
Table 25-1: Nichi-Iko Pharmaceutical/Aprogen Trastuzumab Biosimilar by Indication & Phase
Table 26-1: Oncobiologics Trastuzumab Biosimilar by Indication & Phase
Table 27-1: Paras Biopharmaceuticals Trastuzumab Biosimilar by Indication & Phase
Table 28-1: Pfizer Trastuzumab Biosimilar by Indication & Phase
Table 29-1: PlantForm Corporation Trastuzumab Biosimilar by Indication & Phase
Table 30-1: Polpharma Trastuzumab Biosimilar by Indication & Phase
Table 31-1: ProBioGen AG/Bio Farma Indonesia Trastuzumab Biosimilar by Indication & Phase
Table 32-1: Reliance Life Sciences Trastuzumab Biosimilar by Indication & Phase
Table 33-1: Samsung Bioepis Trastuzumab Biosimilar by Indication & Phase
Table 34-1: Shanghai CP Guojian Pharmaceutical Trastuzumab Biosimilar by Indication & Phase
Table 35-1: Shanghai Henlius Biotech Trastuzumab Biosimilar by Indication & Phase
Table 36-1: STC Biologics Trastuzumab Biosimilar by Indication & Phase
Table 37-1: Therapeutic Proteins International Trastuzumab Biosimilar by Indication & Phase
Table 38-1: Zydus Trastuzumab Biosimilar by Indication & Phase
Table 39-1: Glycotope Trastuzumab Glyco-optimised by Indication & Phase
Table 40-1: Trastuzumab Subcutaneous by Indication & Phase

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- ISU Abxis
- Allergan/Amgen
- Alteogen/Cristalia
- AryoGen Biopharma
- Axxo
- Biocad
- BIOCND/Genor Biopharma
- Biocon/Mylan
- Bionovis/The Instituto Vital Brazil
- BioXpress Therapeutics
- Celltrion
- Curaxys
- Dong-A ST/Meiji Seika Pharma
- Dr. Reddy's Laboratories
- Gedeon Richter
- Hanwha Biologics
- Harvest Moon Pharmaceuticals
- Hetero Drugs
- International Biotech Center Generium
- Mabion
- mAbxience
- Nanogen Biopharmaceutical
- Nichi-Iko Pharmaceutical/Aprogen
- Oncobiologics
- Paras Biopharmaceuticals
- Pfizer
- PlantForm Corporation
- Polpharma
- ProBioGen AG/Bio Farma Indonesia
- Reliance Life Sciences
- Samsung Bioepis
- Shanghai CP Guojian Pharmaceutical
- Shanghai Henlius Biotech
- STC Biologics
- Therapeutic Proteins International
- Zydus
- Glycotope

Note: Product cover images may vary from those shown
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