An important milestone for Insmed (NASDAQ: INSM), developer of follow-on biologics and biopharmaceuticals, was achieved in the form of approval from the UK's Medicines and Healthcare products Regulatory Agency to initiate their first clinical study for INS-19, a follow-on biologic product candidate. INS-19, is a recombinant form of human G-CSF, is a follow-on biologic of Neupogen®. Amgen (NASDAQ: AMGN) booked 2007 sales of Neupogen® that approached $900M, and the patent expires in 2013.
The Phase I study will be conducted in the UK and will compare the safety and establish the bioequivalence of INS-19 to Neupogen®. Results from the trial are expected in 2H08, and are planned to be used as part of a submission to the FDA to establish a protocol with the agency for a Phase III trial in the U.S.
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