BIO DOWNPLAYS BIOGENERIC STUDIES

As Capitol Hill contemplates proposed legislation to establish approval mechanisms and analytical processes at the FDA to facilitate biogeneric entry, biotech firms are urging federal lawmakers to reject assertions in two highly publicized studies that claim follow-on biologics would save billions in healthcare costs.

"Congress needs to have more straightforward information on when [biologic] products are going off patent," Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood said, adding that more accurate information is needed to safely and effectively approve follow-on biologics.

Greenwood's comments came in response to studies by the Pharmaceutical Care Management Association (PCMA) and Express Scripts that say using biogeneric drugs would save the government and consumers billions.

In a report released last week, BIO researchers questioned the validity of the claims in the reports, pointing to nine specific flaws BIO identified in its own review of the reports.

For example, BIO said assumptions about patent expirations are inconsistent with credible analyst reports, casting doubt on the assertion in the Express Scripts study that more than $40 billion can be saved by increasing access to follow-on biologics. BIO also downplayed the report's estimation that interchangeability could lead to an additional $13.8 billion in potential savings.

Flaws in the PCMA study cited by BIO include calculation errors that may have overestimated savings asserted in that report.

( http://www.fdanews.com/did/6_41/ )