The Indian biosimilars market, which was $200 million in 2008, is expected to grow to $580 million by the end of 2012 according to a study. Key biosimilar enterprises like Dr. Reddy's Laboratories Ltd,  Cipla and  Biocon with other significant ones like Ranbaxy, Wockhardt, Intas, Shantha Biotech and Bharath Biotech have seen large investments and alliances over the last three years, it adds.

“The emerging gateway for Asian pharmaceuticals to combine growth in biotech with the need of pharma is via biogenerics or modifies follow-on biologics. With growing confidence in the region, synergistic alliances shall become more and more common,” the study  says.

Releasing the white paper — The Asia Promise — at the eighth edition of the BioAsia conference  recently, Mahadevan Narayanamoni, national leader (healthcare and life sciences advisory), Grant Thornton India, said: “Asia promises to be a biotechnology hub and this is made evident by the growing number of cross-border collaborations in 2010. India, China and Japan, which witnessed largest deals last year, signify that Asia is shifting strategically from a mere outsourcing destination to a centre of innovation.”

At the same time according to a Datamonitor research study, despite the fact  the biosimilars market is in its infancy, the Indian manufacturers are well positioned to capitalize on the future growth of this market both domestically and internationally.

Says Alistair Sinclair, healthcare analyst at Datamonitor,”The domestic market for biosimilars in India is limited by low levels of health insurance and therefore poor access to biologic drugs; however given the high level of branded-generic loyalty of the emerging middle class, this could act as a driver of biosimilar uptake.

“Due to the fact that many copycat biologics are already available in India and often approved as new drugs rather than biosimilars, it is difficult to quantify biosimilar sales in the emerging markets. Nevertheless, estimates in India range from as low as $20m and as high as $200m. This could be expected to grow to $580m by 2012.”

Whilst the domestic market shows potential, many Indian biosimilar manufacturers are also looking to expand globally. “The developed pharma markets may be difficult to access alone due to the complex and expensive clinical trials and registration process. However, licensing agreements with multinational companies can facilitate access to these markets.”, he points out.

The two key factors that can work favourably for Indian biosimilar companies in the domestic market are  the relative cost advantage of biosimilar development  and  relatively lower regulatory requirements for establishing bioequivalence. The relative cost advantage of biosimilar development compared to their competitors  reduce the appeal of imported biosimilars and help them to maintain their competitive edge. Moreover  the relatively lower regulatory requirements for establishing bioequivalence helps to keep their development costs low.

India being  a semi-regulated market  Phase I-II trials are typically not required for biosimilar approval in India unless it is found necessary in special cases. Phase III trials with a minimum of 100 patients are mandatory for establishing bioequivalence. The total cost to develop a biosimilar in India can therefore range from $10 – 20 million, which helps Indian companies to offer their products at a 25-40% cheaper price than the original biologics.

At the same time according to some industry observers,delayed regulatory approvals, cumbersome multiple clearances, lack of access to capital and infrastructure support are hampering the growth of the India’s biosimilar industry. In order to speed up process, the Association of Biotechnology Led Enterprises (ABLE) has submitted a proposal to the Department of Biotechnology (DBT) to provide the biotech industry with a clear regulatory structure for the growth of the biosimilar sector.

Going by the disease profile, biosimilar drugs are proving to be the answer for conditions from cancer to cardiovascular conditions. Biosimilars drugs are cheaper by 30-40 per cent.

There is a huge market opportunity for biosimilars as 48 drugs valued at $73 billion are going off patent globally within the next 10 years. In India, around 20 companies including Biocon and Intas among others are gearing up to be part of the biosimilar producers bandwagon. A visible trend is the interest evinced by the pharma companies who have made efforts to enter the space.

Currently, in India it takes 14 to 16 months for the approval process and if procedural aspects are streamlined there would be reduction of 25 per cent of this time frame thus saving costs and time-to-market. Challenge for India is affordable healthcare and this is where ABLE took on the onus, to support the industry with a set of simple, faster and clear cut guidelines to in the bio-similar space, said Dr Satya Dash, chief operating officer, ABLE.

In its several rounds of interactions with the biotech industry, ABLE has now assessed the regulatory hassles which include technical lapses, procedural delays, number of windows for clearances and issues in the import-export of biological screens. The Form 12 which is a format for approval of strain imports to develop biosimilars needs annual revisions making it cumbersome for the industry. In order to create procedural efficiency, ABLE has called for a 3-year validity for Form 12, he added.

While there is ample access to biosimilar funding in the government through DSIR, DBT, CSIR among others, there is a paucity for late stage grants. This is where venture capitalists and private equity players must come in. Biosimilar production and research requires a state-of the-art plant, animal breeding facility for rodent and large animals, quarantine facility, cold chain units in airports and expansion of viral test facility across the country.

Indian biosimilar regulatory structure comprises DCGI, Review Committee Genetic Manipulation, Genetic Engineering Approval Committee and institutional board of Ethics Committee. The need of the hour is a single window clearance manned with a team of technical competent experts with a global perspective who constantly interact with the industry. “The presence of single window and proficient regulatory authority would automatically lead to investor confidence. This would also automatically help tackle problems of funding and modern facility”, said Dr Dash.

Now Indian biosimilar companies are targeting unregulated (e.g. some of the African, Eastern European and Latin American countries) and semi-regulated markets, such as China, India, Brazil and South Korea in the short term. Indeed, most of these companies have already launched their biosimilar products in many of these markets. As entry barriers to developed markets are much higher due to stringent regulatory requirements, these markets provide these companies with an interim opportunity to recover their development costs.

Due to the  the rising healthcare costs, developed nations are interested to explore the cost saving potentials offered by biosimilars. For instance, the American Congressional Budget Office (CBO) estimates that potential savings on biologics in the U.S. could be around $25 billion between 2009 and 2018 if a pathway for approval and marketing biosimilars is implemented.

The acceptability of biosimilars is certainly higher in the domestic market. Biosimilar substitution is automatic, which can take place as soon as a biosimilar is launched. The choice of a biosimilar brand is normally made by the physician, in consultation with the patient. Hence, biosimilar companies focus on physicians for improving brand recall and sales potential.