Monday, May 14, 2007
BLOGSCAN - Truthfulness in Biotech
David Williams in the Health Business Blog has another commentary on the need for unvarnished truthfulness in biotechnology. The examples he uses are germane to the debate about generic biotech drugs. In particular, biotech firms contend that different manufacturing processes produce different molecules, so that generic biotech drugs should undergo full-scale clinical trials. So then why do biotech firms only do limited bioequivalence studies when they switch their manufacturing processes? And since these firms often find batch-to-batch variation in their own products, should each batch undergo separate clinical trials?