Gujarat pharma cos tapping opportunity in biosimilars

Global biosimilars market likely to touch $10 billion by 2015, India's share is 3%

Local drug makers are increasingly looking at tapping another off-patent opportunity, that of biosimilars. These can be called the generic version of biologics or drugs that are derived from living organisms or organic substances.

Pharma companies like Cadila Healthcare (popularly Zydus Cadila) and Intas Pharma have drawn up elaborate plans to tap the biosimilars space. While Zydus has a pipeline of 17 biosimilars, Intas is planning to launch a couple of biosimilars this year itself. The company only recently launched a biosimilar version of Rituximab called Mabtas that is used in treating diseases like leukemia and rheumatoid arthritis.

Intas has already developed six biosimilars for the domestic market, and its biotech facility too has received European Union - Good Manufacturing Practice (EU-GMP) certification. "We are working on a few more products and expect to launch at least a couple of them during 2013-14 fiscal. These would be speciality products, mainly in the area of cancer," said a senior official in Intas.

Zydus, on the other hand, has already launched two oncology products, two biosimilars for infectious diseases and one in nephrology. It has invested over Rs 25 crore on setting up a new plant for the manufacturing of biosimilars a few years back. Besides, a dedicated facility, the company has also employed over 170 scientists to develop biosimilars for the domestic as well as international markets. "Besides, the domestic space, we are also looking at tapping the emerging markets an might look at licensing agreements for such markets," said a source in the company. Zydus also has plans to explore co-development opportunities for entering the advanced markets.

Industry analysts expect biosimilars to replace at least 70 per cent of chemical pharmaceutical molecules available in the market today.

A senior official in Alembic Pharma too admitted that biosimilars are emerging as a very lucrative area indeed. "We were mainly focussing on making active ingredients for pharma products, and only recently we have shifted our focus on high-margin formulations. Currently, work on our new formulations plant is on, which would require significant amount of capex. At present we are not present in the biosimilars space, but we do not mind taking a look at it in the long run," he added.

The global biosimilars market is estimated to touch $10 billion (around Rs 5.39 lakh crore) by 2015, and currently India has a very low share at around 3 per cent. China and Korea lead the global biosimilars space. India has a handful of companies which are working on developing products in this segment including Biocon, Reliance Lifesciences, Cipla, and Wockhardt. Intas and Zydus from Gujarat have emerged as potential longterm players.

The Pharmaceutical Exports Promotion Council (Pharmexcil), is quite upbeat on the segment.

As P V Appaji, director general of Pharmexcil puts it, "India has the potential to tap around 20-25 per cent of the global biosimilars space in the next five-six years time." Uncertainties on the regulatory front are,however, obstacles to exports, said a source in Pharmexcil.