Stockholm/New Delhi: Indian drug makers Shasun Chemicals and Drugs Ltd and Wockhardt Ltd are looking to set up research and development hubs in Sweden for ‘bio-similars’ or off-patent versions of biotechnology drugs, in a bid to jump-start their global operations in this segment.

“The two companies are in talks with Karolinska Institute to set up their R&D hubs here," Ylva Williams, director, life sciences, Invest in Sweden Agency, said.

Several Indian pharmaceutical companies have been eyeing the market for ‘bio-generics’ or ‘bio-similars’, copies of patented bio-pharmaceuticals or drugs developed from complex proteins and living organisms. The market for such drugs is projected to grow to $16 billion (Rs64,784 crore) by 2011, according to a Frost & Sullivan study.

Confirming the development, A. Vimal Kumar, director with Chennai-based Shasun, said the company was evaluating the idea of “setting up operations in the areas of biotech there (Sweden)." The idea is at an exploratory stage and “we have taken no final call," he added. Wockhardt’s chairman Habil Khorakiwala could not be reached for comment despite repeated calls. However, Wockhardt has in the past spoken of its plans in the bio-similars area.

The company already sells three insulin products and a blood-disorder drug, erythropoietin (EPO) in India, countries that are part of the Commonwealth of Independent States (CIS), Africa and Latin America. Wockhardt has clinical development activities going on in five such drugs.

“The cost of development, capital investment and operating costs of manufacturing of bio-similars will be significantly higher than for chemical-based generics and there is a lower probability of a successful launch that puts R&D investment at risk. This is new territory for many generics companies," Jo Pisani and Yann Bonduelle, strategy consultants at PricewaterhouseCoopers Llp., said in their report titled ‘Opportunities and barriers in the bio-similars market: evolution or revolution for generic companies?’

However, bio-similars are difficult to make compared with conventional chemical drugs and, therefore, come without one of the disadvantages of generics or off-patent chemical drugs—price erosion. While Europe has already laid out a regulatory pathway for some bio-similars, US legislators are still working on laws that will make them legal.

Karolinska Institute is Sweden’s leading medical university, reputed to be among Europe’s best, and already has a collaboration with the Kiran Mazumdar Shaw-promoted Biocon Ltd for research.

Ranbaxy Laboratories Ltd, Dr Reddy’s Ltd, Cipla Ltd and Biocon Ltd are some other drug makers that have jumped on to the bio-similars bandwagon and are eyeing the US and European markets.

Breaking new ground, Glenmark Pharmaceuticals Ltd has gone a step further and set up a research unit in Switzerland dedicated to novel biotech drugs. Wockhardt and Shasun are part of the growing number of pharma firms that are being wooed by Sweden, Williams added. Sweden has the fourth largest bio-tech industry in Europe, according to an Ernst & Young report, ‘Beyond Borders—the Global Biotechnology Report 2006’.

Such companies, Williams said, were attracted by laws that promote research. Swedish laws, she added, “promotes clinical trials both by the Swedish and the non-Swedish companies."

This will help companies get regulatory approval in Sweden, which, in turn, will help them acquire a footprint in the European Union. Sweden’s geographical location provides these firms access to 800 million consumers in the Baltic Sea Region, Russia and other CIS countries, and the European Union.