Bangalore: Day two of India's premier biotech event, Bangalore India Bio 2013, saw several eminent individuals discuss on the topic of 'Biosimilar guidelines for development of safe, affordable and efficacious biosimilars for the world'.

The session was chaired and moderated by Dr VP Kamboj, chairman, Biotech Consortium India Limited (BCIL), and former director, Central Drug Research Institute (CDRI). The panelists at tthe discussion were Dr PM Murali, president, ABLE and MD, Evolva Biotech, India; Dr Abhijit Barve, president, R&D, Biocon, India; Dr William Lee, head, strategic drug development Asia, Quintiles East Asia, Singapore; and Dr Subir Kumar Basak, president, global drug discovery services, Jubilant Life Sciences, India.

Dr VP Kamboj, said, "Biosimilar guidelines in India was drafted in five intensive sessions by the regulators and academia along with the participation of companies and law makers, so as to make India as competitive as possible in the world. India has found a definite place in generics and is one of the leading countries to take generics to the global market particularly in the US, Europe and Japan. Every company wants to reach the US and Japanese markets because about 40 percent of worlds total drug are consumed in the US and 19 percent in Japan, whereas only 14 percent of the is consumed by Africa, India and Asia together. There is 23-to-25 percent growth in Indian biopharmaceuticals and generics, which is the highest in the world. In 2011, US saved $192 million by using generics. In India about 50 percent of the drugs that is produced are consumed."

Dr PM Murali said that, "There is a tremendous opportunity in biosimilars. India is the capital in biosimilars as it has by captured 25 percent of the $3.4 billion market, which is a big task. The potential, hard-working and extraordinary talent that we have in India will fructify only by proper regulation and implementation by the government and later by companies. A bold initiative was taken by the government to frame, which can be used as a model. Thus a commendable document from the panel was prepared. In 2009, 15 alliances were made globally out of which 12 percent was from Indian companies, indicating that we are heading towards the right track. The investments made in biosimilars are many times more than that in generics. Regulation is going to be the key for targeting and propelling a growth in the next two years .There is a criticism regarding the guidelines that it is suited only for for semi regulated markets and not for fully regulated markets like the US. For every company, regulation must be an enabler and not disable its progress."

Dr Abhijit Barve, said, "There's been a evolution in biosimilar guidelines. The guidelines depend on how every country interprets it. Europe is the front runner in the biosimilars, they regulated the tricky issue of how many clinical trials is important for the efficiency and clarity of the drug. The WHO guidelines are very similar to that of Europe's. The pyramid of biosimilars should have a robust foundation with many steps that make it up like - the funding, studies, research, availability etc. The Indian guidelines grafted is quite similar in comparison with the WHO and European guidelines."