Regulatory Focus™ > News Articles > Biosimilars: Past, Present and Future

Biosimilars: Past, Present and Future

Posted 01 April 2010

Facing steep increases in healthcare costs, US legislators are making a concerted effort to find new ways to reduce them. One approach targets the high cost of biologics. Biologics are typically very expensive. While justifications for their price tags include the high cost of development and manufacture, higher risk of failure and limited markets, a key reason is lack of competition. Unlike drugs, there is no regulatory pathway for approval of generic versions of biologics in the US. Hence, a biologic can survive in the market for a longer time without fear of cheaper competitors.


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