The US government’s proposal to reduce healthcare costs for American consumers by cutting the data exclusivity period for patented biotech medicines will allow low cost Indian drug makers to tap a lucrative segment in the world’s largest drug market. According to the US budget proposal, the government plans to reduce the data exclusivity period to 7 years from 12 years at present from next year. This will provide an opportunity for local drug makers to sell their bio similar drugs much earlier in the US market.
Several local companies are vying to launch their bio similar drug in the US such as Biocon, Dr Reddy’s Laboratories and Wockhardt. The global market for bio similar is estimated at $55-60 billion and estimated to swell to $300 billion by 2020.
Data exclusivity restricts bio similar drug makers to rely on the original clinical studies data for the specified period. The US government’s move to trim the exclusivity period is aimed at balancing the objective of lowering healthcare cost while providing incentives to new drug developers for future research.
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