Inexpensive drugs from India to transform the global pharmaceutical industry—trend toward biosimilars
In this report, partially based on research carried out in India, we make the case that biosimilar antibody drugs (generic versions of biotherapeutics) will become widespread in industrialized nations by 2015, for the following two reasons. First, we think conditions are right for medical authorities in Japan, the US and Europe to start approving biosimilars, including antibody biosimilars. Second, biosimilars can now be manufactured
inexpensively. Regulatory and technological obstacles to the release of biosimilars are now diminishing. We think biosimilars will make rapid inroads if guidelines for their approval are established in Europe, Japan, and the United States. Industrialized nations are likely to approve inexpensive yet effective biosimilars in order to rein in growth in healthcare spending caused by the ageing of their societies. Biosimilars of antibody drugs
have already been approved in India. US and European generic drugmakers have been stepping up partnerships with Indian companies to produce biosimilars, and branded drugmakers are now following suit. We think inexpensive drugs from India will transform the contours of the global pharmaceutical industry.





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