Huffington Post: Data Exclusivity: Getting the Balance Right

Patently BIOtech

Huffington Post: Data Exclusivity: Getting the Balance Right

     A great article on the downsides of cutting or removing data exclusivity provisions for biologics.  The article points out that data protection is needed to enhance safety and create incentives to research and produce new innovative drugs that cost billions of dollars.  However, the author argues that the period must be limited somehow (not 50 years) to ensure generics can entire the market and lower costs.    Finally, the author states that lowering the data exclusivity period from 12 years will only increase the costs of biologics in that period, that sharing drug data will result in an immitative and not innovative medical system, and that longer periods result in safer biosimilars because they are held to the same high standard as the innovator.

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