Herceptin (Trastuzumab) Biosimilar Clinical Trial Insight

Publish Date:- Oct-2016      No Of Pages (85)

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Herceptin (Trastuzumab) Biosimilar Clinical Trial Insight” report by PNS Pharma 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.


Herceptin (Trastuzumab) Biosimilar Clinical Trial Insight” report by PNS Pharma 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.

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


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