By Donald Zuhn --
Insmed Inc., a biopharmaceutical company based in Richmond, VA, announced last week that it was launching a campaign on the importance of establishing a regulatory pathway in the U.S. for follow-on biologics (sometimes referred to as biosimilars or biogenerics). Last summer, we reported that the U.S. Senate Committee on Health, Education, Labor & Pensions passed the Biologics Price Competition and Innovation Act (S. 1695). Although the Senate set the biologics bill aside late last year, it has pledged to resume work on the bill this year.
In its announcement regarding the biologics campaign, Insmed contends that "[t]he scientific, regulatory, and legal framework for the approval of small-molecule generic drugs is well developed," pointing to the biologics regulatory system established in Europe in 2006. Insmed also contends that a biologics regulatory pathway in the U.S. would result in enhanced patient access to and reduced costs for expensive biotech drugs.
As part of its national awareness campaign, Insmed has commissioned an economic study to determine cost benefits to patients and healthcare providers from the establishment of a follow-on biologics market in the U.S., created an online resource of information regarding follow-on biologics, and established an online interactive advocacy program for follow-on biologics. Insmed CEO Dr. Geoffrey Allan stated that the company hopes that "this renewed attention and the inception of these initiatives will shed some light onto the significant need for Congress to adopt legislation so patients can receive affordable access to life-saving biotech drugs."
With respect to the commissioned report, Insmed issued a related statement announcing the release of the report, entitled "The Potential American Market for Generic Biological Treatments and the Associated Cost Savings." The report, which was prepared by economist Dr. Robert J. Shapiro (at left), former Under Secretary of Commerce in the Clinton Administration and current chairman of Sonecon, LLC, a private firm advising U.S. and foreign businesses, governments, and non-profit organizations, concludes 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." Insmed also noted that other published reports have estimated that $10 billion worth of biologic drugs are expected to come off patent by 2010 and that an additional $10 billion are expected to come off by 2015.
Insmed's online resource of follow-on biologics information includes a page discussing the nature of follow-on biologics, the creation of a regulatory pathway, and the company's role in follow-on biologics. This resource defines follow-on biologics as versions of approved biologics that are developed after the original product has been created with the intention of marketing them after the patent on the innovator product has expired. With respect to a regulatory pathway, Insmed argues that because biologics are larger proteins made from living cells, product variability should be addressed by requiring abbreviated clinical testing to make sure that differences between the innovator product (brand product) and biologic will not adversely affect the safety and efficacy profile of the drug.
Insmed acknowledges that it would stand to benefit from the establishment of a follow-on biologics regulatory pathway in the U.S. since, as a developer of follow-on biologics, Insmed would be "prepared to enter the market as soon as [such a pathway] becomes a reality." With regard to its own biologics program, Insmed announced its intention to initiate clinical trials this year on its first two follow-on biologics, both having brand sales of over $3 billion worldwide.
In a third related announcement, Dr. Allan commented on both the Bush Administration's FY 2009 budget, which includes a plan to seek authority for the Food and Drug Administration (FDA) to approve abbreviated applications for follow-on biologics (see "FDA $2.4B Budget Includes Follow-on Biologic Pathway"), and the FDA's proposal to assist Congress on its follow-on biologics legislation. Dr. Allan stated that the company "hope[s] that the attention this important issue has received from both the White House and FDA will move Congress to adopt follow-on biologics legislation so patients can receive safe and affordable access to generic versions of these life-saving biotech drugs."
For additional information on this and other related topics, please see:
• "Millennium Pharmaceuticals Spent $1.28 Million on Lobbying in 2007," February 8, 2008
• "Biologics Legislation Faces Unresolved Issues," December 28, 2007
• "BIO CEO Provides Briefing on Follow-On Biologics and Patent Reform," September 18, 2007
• "Biotechs Facing New Challenges," August 13, 2007
• "Three New Biosimilars Pass EMEA Test," July 26, 2007
• "European Medicines Agency Releases Paper on Biosmiliar Medicines," July 23, 2007
• "Senate Committee Passes Biologics Legislation," July 5, 2007
Comments