Follow-on Biologics Bill Reintroduced in Congress

Most pharmaceuticals made using biotechnology are approved through a Biologic License Application (BLA) rather than a New Drug Application (NDA).  The FDA requires essentially the same type of evidence for both biologics and conventional (i.e., small molecule) drugs; namely, results of adequate and well-controlled clinical trials demonstrating safety and effectiveness.  However, currently there is no abbreviated pathway for the approval of generic, or "follow-on", biologics like the Abbreviated New Drug Application (ANDA) pathway for the approval of conventional drugs.

The "Access to Life-Saving Medicine Act," reintroduced by Rep. Waxman, Sen. Schumer, and other lawmakers yesterday in the House and Senate, would establish an abbreviated approval process for follow-on biologics.  According to an AP story out today, a new report by Express Scripts, a pharmacy benefits manager, finds that generic biotech drugs could save patients and insurers $71 billion over 10 years.  This report from the Pharmaceutical Care Management Association, an industry trade group for pharmacy benefits managers, says Medicare Part B would save $14 billion dollars over that time.  Pharmacy benefits managers earn big profits from generic drugs.

Rep. Waxman's website contains a great deal of information on this issue, including a background on biologics, a summary of the proposed Act, and the full text of the Act.  Additionally, the website contains letters of support from the generic drug industry, consumer groups, and insurance companies.  Another perspective is offered by the Biotechnology Industry Organization, which represents innovator pharmaceutical and biotechnology companies.  BIO's website has a section devoted to the issue of follow-on biologics, and contains information on developments in Europe as well as the United States.

UPDATE:  22-Feb-07 BIO response to Express Scripts and PCMA studies