U.S. Regulations Take Shape for Follow-On Biologics

Bipartisan members of Congress were working toward an agreement on new regulations at CW’s press time last week that could enable the swift approval in the U.S. of generic biologic drugs, otherwise known as biogenerics or follow-on biologics. The regulations could open the door to a wave of lower-cost biotech drugs. Prospects for a new bill to facilitate the introduction of biogenerics have improved since the Democrats took control of Congress, industry representatives say. The U.S. FDA says it would welcome a new biogenerics bill. Janet Woodcock...

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