As reported in Pharmalot blot, if you want to know what the FDA thinks about biosimilars and how to gauge immunogenecitiy or when bioequivalence studies will be needed? Then you may want to attend the two-day hearing the agency has scheduled on Nov. 2 and 3 at its Silver Spring, Maryland campus. Although not formally announced, a draft notice has been circulating for the past few days.
This is seen as a signal that the agency is formulating a policy towards biosimilars in response to the go-ahead given by Congress in the health care reform bill. A key unanswered question surrounds testing standards the agency will require of drugmakers to ensure that biosimilars match brand-name treatments in both safety and efficacy.
Posted by Bruce Lehr September 20th 2010.