Association of Biotechnology Led Entrepreneurs (ABLE) views the proposal of the Union government to set up the National Biosimilar Centre (NBC) at Bengaluru as a sea change for the biotech industry. It will not just attract investments from global companies but will help India to encash its biosimilar research and manufacturing.

India is looking at an opportunity to be viewed as a biosimilar development and manufacturing hub that can mirror its growth in the small molecule generic space. It would make the country a global leader in biosimilar manufacturing and kick start the positive spillover affect as was the case with automobile industry. “Indeed we would like to see the NBC set up and commissioned at the earliest along with its regional centres across the country,” Dr Satya Dash, COO, ABLE told Pharmabiz.

“To let go of this opportunity will be a huge blunder. As reported by the ABLE-PwC report two years ago, biologics with 2009 sales revenue of $73 billion are going to go off patent in the next decade. The window of opportunity is not going to last for long as other countries particularly China, Malaysia, Singapore, Brazil and even East European countries such as Poland and Czech Republic are at our heels,” he added.

In order to maximize significant benefits ensuing out the NBC, the government needs to reduce the technology and regulatory gap that many of start-up companies are facing. It will also need to address the growing shortfall of trained manpower.

Biosimilars and other biologics such as vaccines need highly trained staff and the industry will be assured that if the Centre could help in training especially in biochemical engineering aspects covering from cell line generation and manipulation techniques to batch processing. The training should be rigorous and hands-on to ensure that industry-ready candidates are created. It should look at incentivizing the training process by providing scholarship of Rs.20,000 a month for 18 months. This will be a win-win situation for the government and the industry, said Dr Dash.

Giving the paucity of time to prove the Indian expertise in the biosimilar and grab the outsourcing and export orders in the wake of a stiff competition from developing markets, the government to make headway in supporting the existing biosimilar companies in terms of transforming the regulatory landscape across the world. Only the government can provide the base for the industry to help navigating the regulatory maze.

A big relief is that the infrastructure for NBC provides common core lab facilities that many firms in the biosimilar space use. Some of the technology and instruments are prohibitive to acquire. Housing high-end instruments under a pay per use model will help business model thrive. It could also provide provision to send samples for comparability testing.

A critical aspect is that NBC should be run professionally and it is best to operate as an autonomous Public Private Partnership venture. It can be successful if the services match industry timeline expectations. If the go ahead is given by the government, the NBC in Bengaluru which already sports a biosimilar research and manufacture environment with the presence of companies like Biocon, Kemwell among others can be made operational in 18 months, said Dr Dash.