A trastuzumab for the treatment of HER2-positive metastatic breast cancer in India.
CANMAb�, developed jointly by Biocon and Mylan under a global partnership, is being introduced for the benefit of patients in India.
Breast cancer is the most prevalent cancer among Indian women ahead of cervical cancer and CANMAb� will offer a high quality, more affordable option to breast cancer patients in India.
Approximately, 1.5 lakh new patients are diagnosed with breast cancer every year in India, of which nearly 25% cases are HER2-positive and eligible for treatment with CANMAb�. Lack of affordable treatment options has limited the extent of HER2 testing and it is believed that the proportion of HER2-positive patients is probably higher.
Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon Ltd, said, "Biocon intends to make a significant difference in the treatment paradigm for HER2-positive breast cancer in India by enhancing access to more affordable treatment with CANMAb� (trastuzumab), which offers the same level of safety and efficacy as the reference product. The launch of CANMAb� in India is an important milestone for our biosimilars program and demonstrates our ability to deliver on our promise of affordable innovation with a high quality, world-class product."
CANMAb� is a targeted therapy for the treatment of HER2-positive breast cancer and acts by interfering with HER2 protein production and stopping the growth of cancer cells. It is easy to administer and will be given intravenously, once every 3 weeks or on a weekly basis depending on the patient's condition.
Unlike the product currently available in the market, both 150 and 440 mg formulations of CANMAb� can be stored for 1 month which is an important offering for patients in India, as it will ensure that there is no under dosing or wastage of drug which is quite common today.
CANMAb� is being manufactured at Biocon's biologics facility in Bangalore and will be available to patients around the first week of February 2014. CANMAb� will be available at about 25% discount to the current list price of the reference product in India, which is already significantly lower than its price in developed markets.
Developing a quality biosimilar monoclonal antibody requires high technical skills, significant investments in clinical development and manufacturing and long gestation periods resulting in significantly higher costs of development and manufacturing compared to common chemistry-based pharmaceutical drugs.
India is witnessing increased usage of targeted therapies like biologics as compared to cytotoxics. This trend is likely to continue given the improved treatment outcomes.
The relatively higher cost of developing biologics means these drugs remain unaffordable for a large section of the population. The introduction of high quality product like CANMAb� will make access more affordable and thereby expand the patient pool.
Till date, over 5,500 patients have benefitted from this novel product.
Single vial for injection.