A report released February 11, 2008 by former Under Secretary of Commerce Dr. Robert J. Shapiro identifies potential cost savings of approximately $378 billion over the next 20 years from making follow on biologics (FOBs), or generic biologics available in the U.S.
The econometric study found 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."
According to other published reports, an estimated $10 billion worth of biologic drugs are expected to come off patent by 2010, with an additional $10 billion by 2015. FOBs would provide safe and effective therapies at a reduced cost following the expiration of the original product's patent.
Dr. Shapiro's report, entitled "The Potential American Market for Generic Biological Treatments and the Associated Cost Savings," also finds that "...the economic and medical benefits from generic biologics should be as great or perhaps even greater as those from generic forms of traditional pharmaceuticals..."
The scientific, regulatory and legal framework for the approval of small- molecule generic drugs is well developed, and a regulatory system for approving FOBs was established in Europe in 2006. However, no regulatory pathway currently exists for FOBs, which are also commonly referred to as biogenerics, in the U.S.
The release of Dr. Shapiro's report is part of Insmed's broad education campaign on the importance of establishing a regulatory pathway in the U.S. for large molecule protein-based drugs, known as follow-on biologics (FOBs), which are also commonly referred to as biosimilars or biogenerics.
Dr. Shapiro's full report, commissioned by Insmed, Inc. a Richmond, VA and Boulder, CO-based biotechnology company, is available on Insmed's website at: http://www.insmed.com.
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