Generic Biotech Drugs Could Save $71B in 10 Years

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 pathway for the approval of 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 says Medicare Part B would save $14 billion dollars over that time.

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, it contains letters of support from the generic drug industry, consumer groups, and insurance companies. The Biotechnology Industry Organization [BIO] offers additional information regarding follow-on biologics on BIO's website.