‘’Biobetter drugs principal foundation of science to provide cost effective drugs’’

How many Indian companies are in the process of developing biobetters and by when are they likely to be introduced in India? Do you think this could be a viable path to success?

Dr PM Murali

Reliance Lifesciences, Dr Reddy’s Laboratories, Biocon and a number of other companies are having a good pipeline. I think most of their launches will happen when some of the patents expire. These are just some of the companies. There are a number of others who will also be coming out with other products.

Tell us about the regulatory hurdles likely to be associated with biobetters approval?

We formulated a robust biosimilars policy. The hurdles currently are on clinical trials. I am assuming this is being addressed. There are several other operational and administrative issues, which I think can be solved with a sound dialogue.

Biobetters will require a full set of clinical trials approved by the regulatory agencies. Do you think India’s regulatory system is ready for it?

Clinical trial issue is being addressed by the Supreme Court. I have a feeling that once the fundamental issues are addressed, we will have a good environment to work. This is not just for biosimilars or original biologics that can come from Indian companies but also for new chemical entities (NCE’s) and other devices that are going to emerge from India.

Why should Indian biopharma companies move towards the biobetters market?

The world looks for a number of products. India will play a key role in the coming years. The pipeline is robust. If the enabling environment is created, we stand to gain a lot in the future.

Do you think biobetters will bring business competitiveness in the market and provide cost effective drugs?

Yes. That is the principal foundation for this branch of science.

Presently, how big is the Indian biosimilars market and do you think this market will get adversely impacted by biobetters? Is it likely that biobetter players will kill the business of biosimilar players?

It is tough to give numbers here. But biosimlars is currently near $4 billion. And I expect that it should grow at compounded annual growth rate of 25-30 per cent.

Going forward, what is the growth potential of biobetters in the global and Indian life science industry?

If a superior drug at affordable costs can be developed and sold, there is nothing like it for the healthcare industry. Also, diseases like cancer will greatly benefit by giving adequate thrust to this area.

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