Biocon's genetically engineered monoclonal antibody BioMAB approved by the Drug Control General of India for head and neck cancer conditions is now undergoing 15 global trials for different cancer conditions. These include colorectal, lung, glioma, cervix, prostrate, gastrointestinal, etc.

The international trials are in different phases of I, II and III across the world, stated Dr Subir Basak, general manager, business development, Biocon Ltd.

BioMAB is a therapeutic monoclonal antibody-based drug for treating solid tumours of epithelial origin, such as head and neck cancers. The drug was launched in the latter half of 2006. The product was highly appreciated by oncologists for its consistent response in clinical trials initiated in India and globally before it was officially launched.

Presently in India, BioMAB is undergoing post marketing surveillance and has proved to be the best in class for head and neck cancers, going by its highly specific targeted therapy. There is a good response and increasing survival rates with no potential side effects. BioMAB is a new paradigm in the treatment of cancer going by the 150 follow-up cases in terms of its efficacy and safety profiles, Dr Basak said.

The product is manufactured at the state-of-the-art facility at the Biocon Park located at Bommasandra Industrial Area phase III in the outskirts of Bangalore.

The drug is the first-of-its-kind to be clinically developed in India and is the first anti-EGFR humanized monoclonal antibody for cancer (head and neck) and is now available in South Asia, Africa and in the next one year will be ready for the regulated markets foray beginning with Europe. It is also marketed in Pakistan through an exclusive license agreement granted to Ferozsons Laboratories Ltd.

Head and neck cancers are reported around 100 per 100,000 populations. The highest rates of this cancers are in South Asian countries like India and Sri Lanka. The Indian sub-continent accounts for one-third of the world burden of head and neck cancers. While the disease was known to affect the lower economic strata of the population because of smoking and chewing tobacco, pan masala and ghutka, it is now affecting the affluent classes going by the increasing number of cases detected. In rural India, one in every 25 cancer cases is head and neck.