RICHMOND, Va., April 10 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced receipt of a letter and questionnaire from the Chairman and Ranking Member of the U.S. House of Representatives' Subcommittee on Health on the possible development of legislation to establish a Follow-On Biologics (FOBs) regulatory pathway.
Sent to approximately 30 stakeholders in the biotechnology industry, healthcare and patient communities, the letter notes that the " ... Members of the Subcommittee on Health are committed to this issue" and has requested Insmed's input "to better evaluate the merits, benefits, and costs of a biosimilars bill ... " Included in the letter for response are six pages of questions covering a range of related issues, including science, potential economic impact, incentives, and innovation.
Insmed intends to submit responses to the Subcommittee in advance of the April 22, 2008 deadline.
"We are very pleased that Insmed has been selected by the Subcommittee for input on this important issue," said Geoffrey Allan, Ph.D., CEO of Insmed. "We are pleased to be at the forefront of this critical healthcare initiative, look forward to submitting our thoughts and welcome the Member's commitment to adopt legislation so patients can readily receive affordable access to life-saving biotechnology drugs."
Insmed is currently developing a portfolio of FOBs and intends to
initiate clinical trials for its first two FOBs in 2008, both of whose
brand sales represent over $3 billion in current sales worldwide. Members
of Insmed's skilled biologics team have worked on the development of 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
|SOURCE Insmed Inc.|
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