Burgess: Energy & Commerce Overlooking Biosimilars Safety Concerns

After a panel of experts echoed his concerns this week, a top House Energy and Commerce Republican stepped up his charge that Democratic leadership on the committee is ignoring the fact that FDA may be struggling with safety concerns surrounding the healthcare reform law provisions that created the accelerated biosimilars approval pathway.
A July 19 panel [...]

FDA’s FOBs Implementation Begins With Meetings Both Public And Private

FDA is advancing its development of the follow-on biologics pathway on multiple tracks, leaving firms with a question of how best to proceed: wait for FDA to settle its processes through public efforts or approach the agency and try to get application-specific advice in private.
Both approaches carry risks. Waiting saves resources in the short-term, but [...]

Experts concerned about lack of clinical trials for biosimilar drugs

Medical experts on Monday warned that the absence of mandatory clinical trials for biosimilar drugs could compromise their safety and effectiveness.
The Democrats’ new healthcare reform law outlined a pathway for the Food and Drug Administration (FDA) to approve next-generation biopharmaceuticals modeled on original breakthrough drugs. But the [...]

U.S. Biosimilars: The

Drug companies looking to bring biosimilars to the U.S. market will use existing regulatory pathways like 505(b)(2) or an outright Biologics Licensing Application over a new regulatory pathway provided in the health care reform legislation because of provisions in the new pathway that favor brands, Jeff George, the head of Sandoz, predicted.