Indian companies are rapidly gaining both expertise and experience in bio-generics like hepatitis B vaccine, recombinant-insulin, recombinant erythropoetin (EPO), Granulocyte Colony Stimulating Factor (GCSF), interferons, streptokinase etc. The market opportunity for such bio-generics is huge and Indian biotech companies can play an important role.

The country has already accepted the concept of "bio-generics" which has played a significant role in lowering the prices of such biotech drugs, which would have been unaffordable, Kiran Mazumdar-Shaw, chairman and managing director Biocon Limited; head, Vision Group, government of Karnataka and chairperson, CII National Committee for Biotechnology told pharmabiz.com. "It is only a matter of time when the regulatory authorities in Europe and USA will be prepared to accept bio-generics," she added.

By 2006, biopharmaceutical drugs which are very different from the pure chemical molecules of the traditional drug industry that is worth $8.29 billion will go off-patent and open up a $4 billion to $5 billion opportunity for companies that can create quality biopharmaceutical generics or bio-generics, said Dr Villoo Morawala Patell, Founder & CEO, Avestha Gengraine Technologies Pvt. Ltd.

With much scepticism about bio-generics market, Dr K Nagarajan, corporate advisor, R&D, Hikal Ltd, said that it was a difficult area as even US and Europe are looking at the modalities on how to establish the norms for bio-generics. The US FDA is in the process of developing guidelines for bio-generic products which has suddenly caught on even in India.

Delving in to the issue that when a few biotech companies in the country are engaged in research on generic equivalents of certain original discoveries despite the absence of regulatory guidelines for bio-generics even at the global level, Shaw, said, "The Indian industry should tread cautiously while filling the big capacity gap in monoclonal antibodies, a major therapeutic line in the near future. Authorities will also have to handle emerging legal changes and regulatory issues like approvals."

Like any other drug, which is in demand, biotech scientists are keen to see that bio-generics will become a reality. According to Dr Shrikumar Suryanarayan, president, Research and Development, Biocon Limited, the problem with bio-generics is that these are basically large biological molecules where it would be difficult to employ the analytical techniques, mainly because of lack of equipment technologies to study the characterization of the molecules. The process is far simpler in the case of small molecules with lesser molecular weight.

For regulatory authorities it is critical because even if they would be keen to introduce the cheaper generics it cannot be done at the cost of patient safety. Hence bio-generics will have to face the hurdle of clinical trails simply because analytical technology is not sufficiently advanced. So it is an extra financial burden to bring out the bio-generics to the market. When Biocon decided on bio-generics route, it set up Clinigene only to conduct clinical trials in-house, informed Suryanarayan.

"There is a huge potential market for bio-generics because original drugs are extremely expensive and this is the main reason for bio-generics opportunity to be big," informed Dr Patell.

With over 350 biotech drug products in the pipeline worldwide, the Indian biotech industry has a major challenge of filling the manufacturing capacity in the field, said Prof G Padmanabhan, scientist emeritus and former director, Indian Institute of Science.

In the wake of bio-generics potential, the Indian, industry and authorities need to gear themselves up to the fast-changing scenario, informed scientists from National Centre for Biological Sciences (NCBS).

The main opportunities are expected to be in the area of bio-processing and bio-manufacturing in the coming years, when several common drugs will go off patent, leading to many bio-generic drugs, informed scientists from the departments of Molecular Biology and Biochemistry at the Indian Institute of Science.

According to industry forecasts, these bio-drugs will replace 70 per cent of conventional therapies by 2025.

It was the Hatch-Waxman Act of 1984 that dealt with only generics of conventional drugs, it left biopharmaceuticals strictly alone, Dr Patell said.

In spite of this, there is no deterring bio-generic players. They are simply concentrating on markets in Europe and Asia, where bio-generics regulations are relatively easier, while waiting for the proper laws to be passed in the US. And also, since post-marketing monitoring is mandatory for biologics, it may also work in favour of the bio-generics firms to be able to introduce these drugs in the developed markets more easily. The logic is that when a huge patient population has already consumed the products for a long time, it is easier to move into the regulated market without expensive doing clinical trials.

Indian firms are right now waiting for regulatory issues to be cleared - both at home and abroad. The industry is seeking clearly defined rules for regulatory approval on par with international standards.

According the heads of research labs at Hikal Ltd. Biocon, Avestha Gengraine, Micro Labs, Bal Pharma and scientists from the Indian Institute of Science, National Centre for Biological Sciences the regulatory approvals was the biggest hurdle for the biotech industry in the country. Almost all industry leaders recommended a "single window" clearance mechanism for biotech products.

Commenting on the three-deck regulatory apparatus for biotech products in India, Shaw stated that the Biotech sector needs a streamlined and simple regulatory framework. The present 3-deck system is unsatisfactory.

A major hurdle facing the biotechnology industry is the presence of a large number of regulatory agencies dealing with this sector, asserted Dr Patell.

It looks like the government is keen to set up a regulatory body after the hue and cry by biotech companies as regulations in bio-generics are a major obstacle only because biotech drugs are to do with life and disease which are sensitive issues, said Shrikumar Suryanarayan.

Also, many of the regulatory agencies strive for consensus in their decisions, which may often lead to long delays in granting final approval to products. This is done mainly to avoid public criticism of the regulator's decision. Most industry leaders agree that the regulatory policies per se are industry-friendly. However, the flawed implementation processes add to the delay in approvals and cost overruns, besides increasing the uncertainty over the final decision.

Above all, these regulators, by and large, do not work with any timelines and are also not required to work with any deadline while handling applications from the industry, averred Dr Patell.

The Karnataka pharma-biotech sector avowed that the future of biotech drugs is bright with immense potential. "With 70 per cent of the drugs in the approval pipeline are biotech drugs, Shaw stated that both biological and chemical molecules would have important roles to play in healthcare. ``However, we are likely to see a greater number of Biotech drugs in the oncology, autoimmune and genetically-inherited diseases," she added.

Work on biological molecules and conventional chemistry molecules must go hand in hand. Research in the field of biotechnology will help us to enter an era of preventive personalized medicine, said Dr Patell.