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Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company
Date:7/10/2008

and 343 +/- 14 ng/mL*hr, respectively. In comparing INS-19 to Neupogen(R), the CI for the ratio of Cmaxs was 92-103% and the CI for the ratio of AUCs was 94-103%. These data demonstrate that the pharmacokinetic behaviour of the products was statistically indistinguishable. Absolute neutrophil count, the primary pharmacodynamic marker for G-CSF products, exhibited the same response profile to dosing with INS-19 as with Neupogen(R).

About Insmed

Insmed Inc. is a biopharmaceutical company with unique protein process development and manufacturing experience and a proprietary protein platform aimed at niche markets with unmet medical needs. For more information, please visit http://www.insmed.com.

The Follow-on Biologics Market

According to 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. Follow-on biologics would provide safe and effective therapies at a reduced cost following the expiration of the original product's patent. A recent econometric study by economist Dr. Robert J. Shapiro, former Under Secretary of Commerce in the Clinton Administration, 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."

About INS-19

Recombinant human G-CSF is a synthetic version of a human G-CSF that is produced in bacteria. G-CSF mimics the biological effects of naturally occurring G-CSF and is used to treat certain medical conditions where a person's neutrophils are too low (neutropenia), such as in cancer patients who are receiving certain chemotherapeutic regimens, patients receiving bone marrow transplants, or in patients who have chronically low neutrophils for other rea
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