Insmed Continues Fight for Generic Biologic Approval
Insmed Inc., a Richmond, Virginia-based developer of follow-on biologics and biopharmaceuticals, 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. “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.”
The Biotechnology Industry Organization (BIO) is lobbying Congress to pass either of two bills pending at the Capitol that will open a pathway for generic biologics to be approved at the FDA. The bills are H.R. 1956, sponsored by Rep. Jay Inslee (D-WA) “The Patient Protection and Innovative Biologic Medicines Act of 2007,” and H.R. 5629, sponsored by Reps. Anna Eshoo (D-CA) and Joe Barton (R-TX), “The Pathway for Biosimilars Act of 2008.” According to BIO, both of these bills support the principles developed by BIO members regarding the creation of a regulatory pathway for biosimilars. Insmed and BIO are not in full agreement about many of the details, most notably BIO’s position arguing for twelve years of data exclusivity for the innovator company.
