"Dr. Shapiro's comprehensive analysis presents a compelling case for the need for Congress to adopt legislation so patients can receive affordable access to life-saving biotech drugs in a timely manner," said Geoffrey Allan, CEO of Insmed, a developer of follow-on biologics and biopharmaceuticals. "The cost savings to the health care system have the potential to be enormous, while the environment for new market participants could introduce competition to these monopolistic markets, similar to that seen in the traditional pharmaceutical generics industry."
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.
Insmed is currently developing a portfolio of FOBs and intends to initiate clinical trials for its first two FOBs in 2008. Members of Insmed's skilled biologics team have worked on over 50 therapeutic proteins. Their focused protein-based drug development backgrounds, coupled with the Company's FDA- approved protein manufacturing facility, and clinical and regulatory expertise, positions Insmed, upon the establishment of a regulatory pathway, to be an initial entrant into the U.S. FOBs market with a broad range of medicines following the expiration of patents covering the innovator products.
Dr. Shapiro is the chairman of Sonecon, LLC, a private firm that advises U.S. and foreign businesses, governments and non-profit organization.
His full report is available on Insmed's website at: http://www.insmed.com. Journalists may contact Dr. Shapiro by calling 202-213-7233 or e-mailing firstname.lastname@example.org.
Insmed is currently developing a portfolio of FOBs and intends to
|SOURCE Insmed Inc.|
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