BIO Raises Concerns Over Studies on Follow-on Biologics

Washington, DC (Feb. 22)-The Biotechnology Industry Organization (Washington, DC, www.bio.org) criticized two separate studies respectively released by the Pharmaceutical Care Management Association (PCMA, Washington, DC, www.pcmanet.org) and Express Scripts, Inc. (St. Louis, MO, www.express-scripts.com) regarding the cost-savings, interchangeability, and market penetration of follow-on biologics.

BIO criticized the studies as legislative debate for establishing a regulatory pathway for approval of follow-on biologics continues. Express-Scripts cited savings of $71 billion over 10 years and $3.5 billion in the first year if a regulatory pathway for approving generic biologic-based products is established. The study may be found at http://www.express-scripts.com/ourcompany/news/outcomesresearch/onlinepublications.

The PCMA study also analyzed potential cost savings and may be found at http://www.pcmanet.org/newsroom/2007/Documents/EN%20Paper%20on%20Follow-on%20Biologics%20Jan.%202007.pdf.

“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,” said BIO President and CEO Jim Greenwood in a prepared statement.

“This debate should be focused on and driven by credible science, fact-based studies, and patient safety,” he continued. “These studies fail to meet these standards. They cannot be relied on 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.”

Among its criticisms, BIO said that assumptions of interchangeability of biologics were faulty and resulted in overestimates of potential cost savings. The BIO study pointed out that the US Food and Drug Administration (Rockville, MD, www.fda.gov) has not yet determined how interchangeability can be established for complex proteins.

BIO also criticized the PCMA study for overestimating the market penetration of follow-on products. “The PCMA study assumes that for every biologic that comes off patent, there will be an associated follow-on product,” said BIO. “There is no credible evidence to suggest that it is scientifically possible to develop a follow-on for every biologic that is currently on the market. Further, many biologics have a limited market, and therefore, it likely will be economically less attractive for companies to pursue manufacturing of follow-ons for many of these products.”

BIO's full response to the studies may be found at  http://www.bio.org/healthcare/followon/20070222.pdf