India is one of the biggest sources of generic industry and is one of
the emerging markets with its high population and investment in
technology. Although India does not have stringent regulations, the
country has a big potential for biosimilars…
If we have a look at the sales figures of Indian biosimilars, 200 million US dollars of sales was recorded in 2008. But according to the analysts, the market will grow to 580 mUSD in 2012, which means a CAGR +30%.
REGISTRATION OF BIOSIMILARS
As described, India is a semi-regulated market and no phase I/II studies are required for biosimilars. To conduct a phase III study is a mandatory step and minimum 100 patients are needed for this study.
Due to the legislation and the environment in the country, the development of a biosimilar can be between 10-20 mUSD in India, much cheaper than the fully regulated countries. And with this regard, the price of a biosimilar, can be 25-40% cheaper than the originator.
If we have a look at the sales figures of Indian biosimilars, 200 million US dollars of sales was recorded in 2008. But according to the analysts, the market will grow to 580 mUSD in 2012, which means a CAGR +30%.
REGISTRATION OF BIOSIMILARS
As described, India is a semi-regulated market and no phase I/II studies are required for biosimilars. To conduct a phase III study is a mandatory step and minimum 100 patients are needed for this study.
Due to the legislation and the environment in the country, the development of a biosimilar can be between 10-20 mUSD in India, much cheaper than the fully regulated countries. And with this regard, the price of a biosimilar, can be 25-40% cheaper than the originator.
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