Industry wants speedy biosimilars reviews

FDA on Monday held the second of a planned series of meetings with industry stakeholders to discuss user fees for biosimilars applications. Biotech and generic drug companies are pressing FDA to adopt more ambitious performance goals for biosimilar product reviews. The agency has proposed a goal of acting on 50% of applications within 10 months of the filing date in FY13 and increasing that goal by 10% annually until reaching 90% in FY17.

According to minutes of the first meeting on June 15, and statements by participants in the second meeting, FDA says the complexity of creating a new approval pathway, as well as the lack of appropriated funds to start the biosimilars program, make it difficult for the agency to achieve higher performance goals. ...