Herceptin (Trastuzumab) Biosimilar Clinical Trial Insight - Research and Markets

Research and Markets has announced the addition of the "Herceptin (Trastuzumab) Biosimilar Clinical Trial Insight" clinical trials to their offering.

The Herceptin (Trastuzumab) Biosimilar Clinical Trial Insight report gives comprehensive clinical insight on 37 biosimilar versions of the Herceptin drug in the clinical pipeline. Currently, there are 4 biosimilars in Phase-III trials and they are expected to be commercially available in the next 5-8 years. Currently, 3 biosimilar versions 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, 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 a full-course treatment, thus allowing the big blockbuster for Roche with sales of US$ 6.79 billion in 2015. It is the drug that remained the 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.

Companies Mentioned

- 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

- Therapeutic Proteins International

- Zydus

- Glycotope

For more information about this clinical trials report visit http://www.researchandmarkets.com/research/6qp6jk/herceptin.

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