US-based Biogenerics Inc is considering to set up a manufacturing base in India for taking up the production of biotech products like Erythropoietin (EPO), G-CSF (Grastim), biotech products for arthritic diseases, animal growth hormones, etc.
This main interest for the company in India is on account of low manufacturing cost the country offers. "We are looking at an option of making India a manufacturing base for biogenerics. The talks are at an infancy level. We found that the cost to manufacture quality biogenerics in India is cheaper by two-third compared to manufacturing in East European countries," said William Haddad, chairman & CEO, Biogenerics Inc.
Haddad is setting up this dream of manufacturing in the country under the belief that by mid-2005, regulatory pathways for biogenerics would be cleared in the US. Regulatory pathways are the guidelines for the R&D, manufacture, and marketing of biopharmaceuticals. The framing of the guidelines have been found difficult on account of difference in the processes required to manufacture a biopharmaceutical compared to a regular pharmaceutical product. "Despite stiff MNC lobbying, generic manufacturers have been assured of firm support from a large section of politicians in US and Europe, which make me feel that by June-2005, pathways for biogenerics will be framed in the US," said Haddad.
"In the next 2-3 years biogenerics like EPO, G-CSF and Interferon would lose their patents. However, due to the lack of regulatory pathways, MNCs will continue with the monopoly of marketing these biopharmaceuticals in the advanced markets. Also they have every chance of winning litigations that come in their way," he added.
These biopharmaceuticals are currently priced very high in the US. With the takeover of generic manufacturers, the price of these products would reduce to one-seventh of the current prices. "The MNCs (original patent holders) would not like this to happen and would try their level best to stop biotech products to go generic," he said. According to him, 40 million population in US find it difficult to pay for their primary healthcare needs.
Biopharmaceuticals meet four of the seven elements needed for successful generics competition, according to consultancy firm Arthur D Little. These include large market size, high prices for the original branded product, limited impact on the cost of goods sold on the branded price and simple, non-proprietary formulation systems. However whether biopharmaceuticals meet three additional criteria - the availability of active substance produced through non-infringing routes, well-characterized actives with easy to match specifications and manageable costs for demonstrating bioequivalence-is still constrained by legal, regulatory and technological issues.