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Campaign Promotes Regulation of Follow-On Biologics
Insmed Inc. (Richmond, VA), has launched an education campaign about the importance of establishing a regulatory pathway in the US for large-molecule protein-based drugs, known as follow-on biologics (FOBs), biosimilars, or biogenerics.
Insmed Inc. (Richmond, VA), has launched an education campaign about the importance of establishing a regulatory pathway in the US for large-molecule protein-based drugs, known as follow-on biologics (FOBs), 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, there is currently no regulatory pathway for FOBs in the US.
Insmed is currently developing a portfolio of FOBs and intends to initiate clinical trials for its first two FOBs in 2008. Members of Insmed's biologics team have worked on over 50 therapeutic proteins. With their protein-based drug development backgrounds, coupled with the company’s FDA-approved protein manufacturing facility, and clinical and regulatory expertise, Insmed is positioning itself as an initial entrant into the US FOBs market.
An estimated $10 billion worth of biologic drugs are expected to come off patent by 2010, with an additional $10 billion by 2015.