Bills Target Biosimilar Drugs

摘要

Makers of biological drugs and their would-be generic competitors drew new battle lines on Capitol Hill last week, in a long-simmering debate over when and how generic versions of these large, complex drugs will enter the US market. Two California Democrats have introduced duelling bills in the House of Representatives; which one emerges as the winner - or what compromise is struck between the two - will indicate how much power and influence the industry lobby has. In his proposed budget for 2010, President Barack Obama supports allowing the US Food and Drug Administration (FDA) to approve generic versions of biologicals, also known as biosimilars. As he seeks to cut soaring health costs, the high prices of biological drugs present an attractive target. Last year, the Congressional Budget Office estimated that a Senate bill creating a regulatory pathway for biosimilars would cut spending on prescription drugs in the United States by $25 billion between 2009 and 2018.rnOther countries have set a precedent for such approval. The European Union opened up a regulatory pathway for biosimilars in 2005, and since then its European Medicines Agency has approved 13 such drugs. Arnnumber of the European guidelines have been adopted in Australia, and Japan this month issued its own guideline for the regulation of biosimilars.