Biogenerics or biosimilars are generic versions of patent-protected biotech drugs. These biocomparables or follow-on biologicals are all set to become the next big contenders for a notable pie of the market share enjoyed by the branded pharmaceuticals and biologicals.

Biogenerics represent a high-growth sector in India, where recombinant insulin, granulocyte colony stimulating factor (G-CSF), interferon alpha, erythropoietin, monoclonal antibody (MAb) products and recombinant vaccines are manufactured by a number of domestic biotechnology companies.

Taken up by the success in information technology industry and generic pharmaceutical industry, Indian policy makers are enthusiastic in repeating the same success in the biogenerics sector. The revenue generated by the Indian biotech industry is expected to jump to $5 billion by 2010 from the current $2 billion. Approximately 60 per cent of this revenue comes from the industry's exports business. Vaccines and biotherapeutics are two dominant segments of the Indian biopharma sector.

A SWOT analysis of Indian biogenerics industry
STRENGTHS
● India has the largest number of US Food and Drug Administration (FDA) approved manufacturing plants outside the US
● Compliance with good clinical practices (GCP) guidelines is on a rise with Indian companies, hospitals and clinics, gaining access to vast and diverse disease populations
● Existence of English speaking medical professionals and personnel with close to 7,00,000 post graduates and 1500 PhD's qualifying in biosciences and engineering each year makes high human resource availability.
● Pharma sector in India has proved to be highly competitive in fermentation-derived pharmaceuticals, which transforms and leverages production of biogenerics
● India's first genetically engineered vaccine costs less than half the price of competing vaccines, which gives a good cost competitiveness
● Biodiversity (plant, animal and microbial diversity) in India present excellent genomic research opportunity

WEAKNESSES
● Biogenerics 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 characterisation 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 biosimilars cannot be assessed and regulated as generic drugs. These are complex molecules, and therefore, quality and similarity cannot be assured by analytical means alone. Also, immunogenicity can cause unexpected effects. Hence, biogenerics will have to face the hurdle of clinical trials, simply because analytical technology is not sufficiently advanced. So it is an extra financial burden to place biogenerics into the market.
● The R&D infrastructure, academic section and overall talent pool are small compared to those supporting the traditional pharmaceuticals industry
● The costs and the technical challenges of developing biogenerics are higher than for traditional generics

OPPORTUNITIES
● It is estimated that by 2010, about two dozen biologics (drugs worth $60 billion) are likely to lose patent protection in US. This is a great opportunity for Indian pharmaceutical industry and can leverage the expertise and capabilities developed in the field of process chemistry
● Government is increasingly implementing cost-cutting policies designed to favour generic usage
● High prices of branded biologics have historically constrained usage, but lower prices of biogenerics could significantly increase demand
● While regulations in US and Western Europe are being sorted out, Indian companies can establish expertise in biogenerics, which can then be transferred to more established pharmaceutical markets

THREATS
● While the development of an abbreviated regulatory pathway is critical to the approval of new biogenerics, growing concerns about the lack of a definition for bioequivalence and increasing pressure from major biotechnology companies anxious to defend their ailing blockbuster patents are preventing the growth of biogenerics market. Moreover, innovators are employing delaying tactics aimed at preventing the biogenerics players from taking shorter routes to approval
● Complexity surrounding the exploitation of intellectual property influences both the cost and time frame of developing a novel biogeneric. Issues arise because both the original biologic and the manufacturing process are patented, along with several essential components and active ingredients required for manufacturing the product

Despite the threats and weaknesses in this front, India seems intent on developing a world-class biotech capability. The Indian government had initiated a programme to promote its own biotech industry in 1980s, when Genentech and other American biotech companies were just beginning to make headlines. In 1982, the National Biotechnology Board was set up under the Ministry of Science and Technology, and it became the Department of Biotechnology (DBT) in 1986. The DBT now spends more than $200 million annually to develop biotech resources in the country.

BIOGENERICS STARS IN INDIA
India's biogenerics industry is still relatively small, and the major four players in this segment are Biocon, Dr. Reddy's Labs, Ranbaxy Labs, Shantha Biotechnics and Wockhardt. These companies account for majority products marketed now, and there won't be much change in it in the near future.

PATH AHEAD
According to industry forecasts, these bio-drugs will replace 70 per cent of conventional therapies by 2025. But there are a lot of things to be achieved and followed for this target. They are:
● Comparability studies are required between the biogeneric and the reference brand medicinal product
● Non-clinical studies, usually less extensive than those for innovator applications, will be required for the biosimilars
● Clinical studies (not only the classic bioequivalence studies conducted for chemical drugs) will be needed to support the biosimilar drug's safety and efficacy. In particular, the studies must address immunogenicity concerns
● Pharmacovigilance plans will be expected as part of approval commitments

ONE STEP AHEAD
'Super-biogenerics' or improved versions of off-patent, first-generation protein drugs, are a huge commercial opportunity for the future. Literally, biogenerics are biologic drugs that have gone off-patent, while super-biogenerics are the second generation of such drugs, with new delivery systems and formulations. So finally, super-biogenerics will represent the next level in the evolution of biogenerics companies.

The most perfect model of a future global biogenerics market would depend on five key competitive foundations: R&D, intellectual property rights, manufacturing, quality and regulatory affairs. European Medicines Evaluation Agency (EMEA) has recently issued guidelines for biogenerics, which will permit Indian companies to apply for approval to market generic versions of biotech products in Europe.

(The author is with Accure Labs Pvt. Ltd., Noida, India)