The U.S. Food and Drug Administration (FDA) has issued new draft guidance aimed at accelerating the development of biosimilar drugs and expanding access to more affordable biologic treatments. The guidance would streamline clinical pharmacokinetic (PK) testing and allow developers to reduce or eliminate certain studies when supported by strong scientific evidence. These changes could significantly lower development costs—potentially reducing PK study expenses by up to 50%, or about $20 million per biosimilar.
The FDA also clarified that developers may, in some cases, rely on clinical data from comparator products approved outside the United States, which could remove the need for additional comparison studies with the U.S.-licensed reference drug. The move is part of a broader effort to modernize biosimilar regulations, encourage competition, and improve patient access to lower-cost alternatives in a market where biologic drugs represent a small share of prescriptions but account for a large portion of total drug spending.
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