With more immunosuppressants coming off patent the question of bio-equivalence and the FDA standards for it have become more prominent. The current standards are simply inappropriate in transplantation, where narrow therapeutic ranges are the norm. Therapeutic drug monitoring can overcome lack of equivalence (assuming consistent manufacturing) but introduces lags and additional costs in achieving and maintaining appropriate levels. Unfortunately, that depth of cost analysis seems to be beyond most insurance companies.
Here are a couple of articles on the topic. The once-daily TAC study is particularly interesting. I’m suddenly more interested in the problem of cherry picking studies for publication prior to FDA approval.
And then there’s Ranbaxy.