By Donald Zuhn --
Earlier this year, we reported on the campaign undertaken by Insmed Inc., a biopharmaceutical company based in Richmond, VA, to raise national awareness about the importance of establishing a regulatory pathway in the U.S. for follow-on biologics. As part of that campaign, Insmed commissioned an economic study of the cost benefits to patients and healthcare providers from the establishment of a follow-on biologics market in the U.S. The study, which was prepared by economist Dr. Robert J. Shapiro, former Under Secretary of Commerce in the Clinton Administration, concluded that "generic versions of the top 12 categories of biologic treatments with patent protections that have expired or that are due to expire in the near future could save Americans $67 billion to $108 billion over 10 years and $236 billion to $378 billion over 20 years."
Last month, we reported that Insmed had retained Bill Thomas, a former Representative from California who headed the House Ways and Means Committee from 2001-2007, to help the company promote a follow-on biologics regulatory pathway. At the time, we noted that Insmed – itself a developer of follow-on biologics – had more than a passing interest in the passage of a follow-on biologics bill. In fact, Insmed released data in July demonstrating the bioequivalence of its INS-19 biologic and Neupogen® in Phase I clinical trials (see Patent Docs report).
Today, The Washington Post reported on Insmed's continuing efforts to teach Congress about biologic drugs and about the benefits of follow-on biologics (see "Biotech Campaigns for Easier Access to Generic Drug Market"). In the article, author Kendra Marr discusses the ultimate objective of Insmed's national awareness campaign: securing quick approval for generic biotech drugs (otherwise known as follow-on biologics or biosimilars).
Ms. Karr notes that two follow-on biologics bills are currently pending in the House and that one bill is pending in the Senate. She also notes that the main point of contention among the various groups lobbying for or against the three bills is the length of an innovator company's data exclusivity. According to Ms. Karr, Insmed, AARP, and the National Organization for Rare Disorders have been pushing for a 5-year period of data exclusivity, while innovator (or brand) companies and the Biotechnology Industry Organization support a 14-year period. While Ms. Karr correctly observes that the longer period of data exclusivity would "allow companies to recoup their investment and conduct further clinical trials to improve the product," she incorrectly notes that the longer period is needed "[b]ecause biosimilars aren't exact duplicates of the original drugs," and therefore "they don't violate the original drug's patent, enabling legal distribution before patent expiration."
With respect to Insmed's generic version of Amgen's Neupogen®, the article quotes Amgen's director of regulatory affairs, Andrew Fox, as stating that "Insmed's limited data appeared to be good data," but also noting that "bioequivalence testing in healthy volunteers does not provide the necessary data on how the biologic actually works in the body, which can only be determined through more extensive clinical testing in patients where safety and efficacy are evaluated." In response, Insmed CEO Dr. Geoffrey Allan observed that "[biologics] make an enormous amount of money," and argued that innovator companies were seeking longer exclusivity periods simply to protect their drug monopolies. The debate regarding follow-on biologics legislation, and the appropriate period of data exclusivity, is expected to pick up steam early next year.
For additional information regarding this and other related topics, please see:
• "Insmed Announces Partnership With Former House Ways and Means Chairman," July 17, 2008
• "Insmed Announces Bioequivalent G-CSF Biologic," July 10, 2008
• "Dr. Robert Shapiro Discusses Follow-on Biologics Report," February 19, 2008
• "Insmed Announces National Awareness Campaign Regarding Follow-on Biologics," February 13, 2008
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