Biotechnology is receiving much attention these days amid predictions that an increasing portion of the world's drugs, food and chemicals will be produced using biotechnology processes. It is also believed that biotechnology will lead to a cure for cancer, common cold and many other diseases. Some early investors have already made fortunes on Wall Street in small biotechnology companies, even though many of these companies have yet to make a profit. Some of the original researchers have also made fortunes, either by starting their own companies or by being offered a partnership in a new company.
Bio generic is an umbrella term used to define the market for bioequivalent products based on the same biological substance used in off patent biologics. The bio generic market is set to develop slowly in the major pharmaceutical markets, as a result of regulatory hurdles and continued protectionism from patented biopharmaceutical marketers. Bio generic products have not yet hit the markets in Europe or United States (US), but are anticipated to achieve successful market penetration, as the patents of major biopharmaceutical blockbusters expire. However, generic biopharmaceuticals have been available in unregulated or semi-regulated markets in Asia (including India and China), Eastern Europe, Africa and South America, as there is less regulatory guidance regarding clinical testing of these products.
Even as bio generics offer significant opportunities in world markets, they pose challenges in highly regulated markets of US and Western Europe. These occur mainly in the form of ambiguous regulatory approval processes and patent issues that make it difficult for manufacturers to introduce bio generics in these areas. Once the market does begin to evolve, the bio generic companies entering the market early will derive significant value.
Some of the key parameters that are required for making the country and company as a bio generic hub are:
■ US FDA approved plants
■ Increasing clinical trials and research
■ High human resource availability
■ Low capital & operational cost
■ Highly competitive bio processing skills
■ Competitive ness of bio generic products
■ Genomic research opportunity
Since the development of the first true biotechnology drug (recombinant human insulin for the treatment of diabetes), about 160 biopharmaceuticals (e.g. recombinant proteins, monoclonal antibodies) have reached the US and EU market for the treatment of a range of human conditions, including rheumatoid arthritis, hepatitis and various cancers. Moreover, about 500 biopharmaceuticals are undergoing clinical evaluation.
In addition, biotechnology can play an important role in the development of therapies in animals (e.g. recombinant feline interferon omega used to reduce mortality) and animal nutrition aids (e.g. recombinant somatotropin - bovine growth hormone - for increasing milk yields of cattle).
Moreover, recent advances in genomics have created new possibilities in genetic diagnosis and detection of predisposition to diseases such as cancer (e.g. BRCA1 test). A number of genetic tests have been performed for disease diagnostic, confirmatory or predictive purposes in Europe alone. Modern biotechnology is also important for designing vaccines targeted at both, preventing disease (e.g. malaria, AIDS) and treating conditions such as cancer (e.g. dendritic cell-based vaccines). Vaccines derived from biotechnology have also contributed to animal health significantly. Vaccines are now used to prevent diseases such as rabies, foot and mouth disease, scours and infections affecting cultivated fish. Finally, cell-based therapies (e.g. stem-cells, tissue engineering) are emerging as a potentially important contributor to regenerative medicine.
Thus modern biotechnology applications offer unique opportunities to respond to unmet health related needs, tailor medical treatment to patients and prevent and better diagnose diseases.
During the past 5-8 years, many countries became strong in the area of producing high quality bio generics products using their indigenously developed procedures and manufacturing facilities. These products are widely marketed at an affordable cost in the developing countries, where the regulatory processes are less strong. But, most of the bio generic companies are working on the most common 12 recombinant proteins, which are off patented like Insulin, Erythropiotin, GC-SF, GMCSF, Human Growth Hormone (hGH) etc. However, recent observations suggest that this potential has not been entirely met, as many applications, including gene therapy, have not yet reached the clinic.
To understand the potential of bio generic market, the regulated countries like US and Europe should be open to it. This kind of initiation not only helps the developing countries but also the developed nations to reduce the health care cost. For this the regulatory agencies should lay down the process of getting the approval for bio generic drug, so that the companies can submit the NDA or ANDA in proper format so that it can be reviewed and approved immediately. Further, if the FDA starts working with the established bio generic companies in the developing countries, then it will be easier to produce the high quality bio generic products at an affordable cost.
Although developing countries like India and china progressed extremely well in gearing up to the international standards in producing the biotech products - about 12 recombinant proteins and 3 monoclonal antibodies in addition to some of the vaccines - these countries couldn't make their headway into the newer biotech products. Hence in the developing countries there is a decline in the share of biopharmaceuticals that offer a therapeutic advance, as the share of "me too" biopharmaceuticals has increased.
To prevent this kind of scenario, either the regulated countries like US, Europe and Japan have to open their markets for the marketing of bio generics or the countries like India and China have to improve their product portfolio or need to come up with delivery systems.
(The author is director Technical with Biovel Life Sciences (P) Ltd)