Dr Ajaykumar Sharma of Frost & Sullivan has a similar view. "Cost of development coupled with huge marketing costs has restricted biosimilars drugs to very few niche areas, such as diabetes, oncology and rheumatology. The highest selling segment in India is still the anti-infectives and cough and cold therapies that were launched almost 20 years ago. Biosimilars need to go beyond the current areas it is serving to make a real dent in the market," he says.

Mr Khandelwal says that this has been a matter of debate and discussions at many industry forums. "This can be looked at from three angles: One is that many Indian players have experimented on different business models. Some have succeeded, some have partially succeeded, and others have failed. We have not analyzed the reasons for the failures or partial successes and learnt from them. Secondly, pharma companies in emerging markets need leaders to address issues in the region. There is a leadership failure in getting the direction right. Lastly, in terms of regulations, we are just not attractive enough as compared to the emerging markets of China and Korea," he points out.

Mr Padmanabhan points out that even globally biosimilars has not really taken off. "Apart from complexity in research, even in terms of regulations, in the US itself there is no pathway for biosimilars. The EU has one but that too is not clear. Once these markets open up, it could prove to be favorable for India."

With the US Food and Drug Administration issuing three draft guidance documents on biosimilars product development to assist the industry in developing such products in the US, Indian companies may have reasons to be hopeful.