Not surprising, is it? The biotech industry is quite edgy that Henry Waxman & Co. are pushing hard for legistaion to have the FDA issue regulatory guidance for developing generic biologics, or follow-ons as they’re called.

Two recent studies - from Express Scripts and the Pharmaceutical Care Management Association, the PBM trade group - are really sparking anger, though. These claimed big savings can be had if follow-ons see the light of day. But BIO says the reports are vapid.

“As a result of numerous flawed assumptions, and the lack of any credible evidence to support these alleged savings, we believe these studies should be rejected as unscientific and unreliable,” fumes BIO ceo Jim Greenwood in a lunchtime missive.

“This debate should be focused on and driven by credible science, fact-based studies and patient safety. These studies fail to meet these standards. They cannot be relied upon in lieu of a more rigorous analysis. Congress should recognize these flaws and misleading assumptions and reject these studies as it evaluates proposals regarding follow-on biologics.”

The debate should also include the high cost of biologics and the ability of the healthcare system to shoulder the expense.

[tags]Biologics[/tags]