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The difficult manufacturing process for follow-on biologics may discourage companies

This article was originally published in The Gold Sheet

Executive Summary

Doug Long, vice president of industry relations for IMS Health, made this prediction at a recent policy meeting sponsored by the Generic Pharmaceutical Association in Washington. Long asserted that while the EU currently has a regulatory approval system for follow-on biologics and will be ahead of the U.S. in developing these products, "U.S. manufacturers will not be far behind." And two key House health legislators, reps. Frank Pallone, D-N.J., and Henry Waxman, D-Calif., asserted at the meeting that Congress will enact an approval pathway for generic biologics this year

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