Mylan and Biocon Unveil Phase III Success Story of Cancer Biosimilar
The global generic drugmaker, Mylan and its Indian partner Biocon unveiled the results of the successful Phase III clinical study of MYL-14010- the biosimilar version of Roche’s breast cancer drug, trastuzumab (Herceptin®).
The data was presented at the 2016 American Society of Clinical Oncology (ASCO) annual meeting.
MYL-14010 is a biosimilar trastuzumab antibody which showed comparable efficacy and safety to the Roche’s FDA approved breast cancer drug, Herceptin. In a randomized Phase III study, 500 women with metastatic, HER2 positive breast cancer received taxane chemotherapy with either Herceptin or MLY-14010 as a first-line treatment.
At 24 weeks the response rates were analyzed which was 69.6% with MLY-14010 and 64% with trastuzumab. It demonstrated equivalent efficacy and safety to trastuzumab with low immunogenicity i.e. it does not trigger an immune response. The common side effect noted was neutropenia (low blood counts). The study was funded by Mylan. It holds exclusive commercialization rights for the biosimilar trastuzumab in US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries.
Figure 1. Molecular mechanism of trastuzumab (Photo credit: flipper e nuvola).
“To our knowledge, this is one of the first clinical trials to show equivalency of a trastuzumab biosimilar to the branded cancer drug,” said Dr. Hope S. Rugo, MD, a Professor of Medicine at the University of California San Francisco.
Breast cancer is one of the most common cancer affecting women globally. Every year, around 1.4 million new cases of breast cancer arise. According to a WHO report, US, India and China collectively accounts one third of the breast cancer patients. In 2012, in US, 232,714 women were diagnosed with breast cancer and 43,909 died. In India, 144,937 were diagnosed with breast cancer and 70,218 died. In the case of HER2 positive breast cancer, an abnormal HER2 gene is present in the tumor.
In 1998, trastuzumab was approved by FDA, as the first drug for breast cancer targeting HER protein.
In 2015, Herceptin raised about $6.6 billion for the company. To combat the biosimilar threats, Roche changed its mode from intravenous to subcutaneous. Herceptin with subcutaneous mode has been launched in 48 countries. To make Herceptin accessible to large population of patients, Roche started patient assistance program (PAP) along with the Cancer Foundation of China in 2011.
Figure 2. Herceptin revenues (Photo credit: Roche Fillings WallStreet Analyst Estimates).
Till now, no biosimilars have been approved by the FDA for the treatment of cancer but the ongoing work towards the development of cheap biosimilars of the branded expensive drug is strongly moving towards FDA approved biosimilar drugs in the market. Clinical trials are going on for the development of biosimilar version of the cancer drug, rituximab and bevacizumab which are present in the ‘WHO’s List of Essential Medicines’ i.e. they are important medications for the basic healthcare system.
In January, Biocad Biopharmaceutical Company announced the approval of its trastuzumab biosimilar- HERtiCAD by the Russian regulatory body.
“Trastuzumab has markedly improved survival of women with HER2-positive breast cancer, but many women around the world can’t benefit from trastuzumab due to its high cost,” said lead study author Hope S. Rugo, MD, a Professor of Medicine at the University of California San Francisco. “We hope that the introduction of biosimilars will expand patient access to this effective drug, which has already benefited the lives of thousands of people across the globe”.
Featured image credit: Digital illustration of Cancer Cells in colour background © vitanovski (Stock Photo ID: 79632028)