The biotech industry globally has completed about three decades and biotechnology approvals are outpacing pharmaceuticals gradually. Asia Pacific region is registering faster growth in biotech sector, in which Australia is leading. Singapore, China and India have significant share in the sector.
Spending on biopharmaceuticals has been growing in the US at a rate of 20-50 per cent annually. As per estimates the spending grew from $ 42 billion in 2004 to $ 69 billion in 2005.
Biosimilars are fast catching up across the world. The Europe has established legislations for Biosimilars, while in the US, legislation has been proposed. Japan too has framed new regulations in this direction. Canada is also discussing on the prospects of biosimilars. Omnitrope, a recombinant human growth hormone (rHGH) of Sandoz was the first biosimilar approved in Europe
Affordable and quality biogenerics, biosimilars or follow on protein products (FOPP as in the US) are now reaching the market place, Dr Ajaz Hussain, former deputy director, Office of the Pharmaceutical Science (OPS), Centre for Drug Evaluation and Research (CDER), US FDA, said.
It is estimated about 300 biotech products are in phase III stage mainly in therapeutic categories such as oncology and infectious diseases, according to Utkarsh Palnitkar, Ernst & Young.
Several Indian companies are strengthening their position in biogenerics. Wockhardt, Biocon, Bharat Biotech, Shantha Biotechnics, Dr Reddy's are some of the prominent companies working in this area. Biosimilars have still a long way to go, Palnitkar added.
The experts were speaking at the fourth annual conference of Biotech Society of India held at Hyderabad in support with CCMB and Shantha Biotechnics, last week.