Generic Biologics Debated in Congressional Hearing

Representatives from the biotechnology industry squared off this week on opposing sides of the debate on generic biologics. Biologics comprise one of the fastest growing and most expensive categories of drugs. By 2009, sales are estimated to reach $90 billion. Many biopharmaceutical drugs are already off patent or will come off-patent, allowing for a generic pathway to create biologics. According to published reports, an estimated $10 billion worth of biopharmaceutical drugs are expected to come off patent by 2010.

Geoffrey Allan, Ph. D., president and CEO of Richmond-based Insmed, Inc., testified this week at a congressional hearing in support of the bill (H.R. 1038) sponsored by Rep. Henry A. Waxman (D-CA) that would authorize the FDA to grant approval of generic biologics.

Dr. Allan was a witness before the House of Representatives Oversight and Government Reform Committee Majority Staff hearing. In his testimony, Dr. Allan stated, "Insmed has developed significant intellectual capital focused towards protein characterization and purification. We have invested in building the facilities required to manufacture quality proteins...The combination of our proprietary protein platform with a biogeneric protein platform meets our goal to sustain innovation along with the ability to provide safe and affordable drugs to address a growing economic issue."

In contrast, Jim Greenwood, President of the Biotechnology Industry Organization, strongly opposes the legislation. "Any legislative discussion of creating a pathway for follow-on biologics must ensure patient safety and preserve incentives for biomedical research and innovation," said Mr. Greenwood. "We strongly oppose H.R. 1038 as it fails to do either. H.R. 1038 would permit the approval of follow-on biologics that do not meet the same rigorous standards of safety, purity, and potency that innovator products must meet; would restrict the ability of the FDA to require whatever clinical testing it believes appropriate to determine the safety and efficacy of such products; would prohibit the FDA from requesting post-marketing safety studies; and would improperly dictate scientific conclusions that the FDA should reach about the comparability or similarity of such products. The legislation also eviscerates incentives to develop new therapies through its one-sided alteration of long-standing patent law in ways that favor follow-on biologics' manufacturers, who would be able to restrict and infringe the intellectual property rights of various parties including universities and innovative biotechnology companies."

At the same hearing, FDA Deputy Commissioner Janet Woodcock told lawmakers it could be a decade or more before the science is available to safely approve generic versions of biotech drugs in the way the FDA approves generics of traditional drugs derived from chemical synthesis.

Dr. Allen told the committee that his company would be well positioned to produce generic biologics, opening up a new level of competition in the industry. "The science has reached a level of sophistication to make this endeavor entirely possible, all we need now is the regulatory go ahead."