Biosimilars dropped from FDARA

Congressional staff made no progress toward reaching consensus on biosimilars legislation in August and have dropped plans to include it in the FDA Revitalization Act (FDARA). The lightened bill, which includes reauthorization of PDUFA as well as new drug safety measures, is expected to reach President Bush's desk by Sept. 21, BIO President Jim Greenwood said last week.

The congressional impasse reflects the large gap between generic drug companies and the biotech industry over incentives for innovation, IP protection and the appropriate regulatory pathway for biosimilars. ...