RICHMOND, Va., Feb. 5 /PRNewswire-FirstCall/ -- Insmed Inc. (Nasdaq: INSM), a developer of follow-on biologics and biopharmaceuticals, today announced that it has launched a 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.
The scientific, regulatory, and legal framework for the approval of small-molecule generic drugs is well developed, and a regulatory system for approving FOBs was established in Europe in 2006. However, no regulatory pathway currently exists for FOBs in the U.S.
Insmed has launched a number of public initiatives to promote awareness
of the need for Congress to establish a pathway for approval of FOBs, which
would enhance patient access to and reduce costs for expensive biotech
drugs. Following Insmed CEO Geoffrey Allan's recent testimony before the
U.S. Congress, Insmed has initiated multiple efforts to enhance awareness
of this important issue, including:
-- The commissioning and upcoming release of an economic study on the
savings a FOBs market would provide to patients and healthcare
-- An enhanced Insmed website containing enhanced FOB resources and
-- Interactive advocacy program utilizing user-generated content and
social networking platforms;
-- Stakeholder outreach and events with patient, healthcare provider,
employer, and policy groups.
"We hope that this renewed attention and the inception of these
initiatives will shed some light onto the significant need for Congress to
adopt legislation so patients can receive affordable access to life-saving
biotech drugs," said Geoffrey Allan, Ph.D., CEO of Insmed. "Given Europe's
previously established regulatory pathway for FOBs, the U.S. is clearly
lagging behind other nations in respondin
|SOURCE Insmed Inc.|
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