FDA Streamlines Biosimilar Testing to Cut Drug Costs

WASHINGTON — A comprehensive review by Reuters, US News, Center for Biosimilars and FiercePharma confirms significant developments in fda streamlines biosimilar testing to cut drug costs. The following key points have been independently verified by at least four respected sources.

• The FDA issued draft guidance on March 9, 2026, to streamline biosimilar development by reducing unnecessary clinical pharmacokinetic (PK) testing when scientifically justified
• The change could reduce pharmacokinetic study costs for biosimilar developers by up to 50%, or about $20 million per drug
• Biologic medicines make up about 5% of prescriptions but account for 51% of drug spending in the United States
• The agency will allow companies to use clinical data based on comparable versions of drugs approved outside the U.S. without running additional three-way studies
• This represents the fourth revision of the biosimilar guidance, replacing the 2015 version
• FDA Commissioner Marty Makary stated this reflects the agency’s commitment to lowering drug costs for everyday Americans
• The agency has approved 82 biosimilars for use in the United States to date
• The new guidance eliminates requirements for certain comparison studies between the proposed biosimilar, U.S.-licensed reference drug, and foreign comparator

Additional Details Reported

The FDA’s decision to ease biosimilar testing requirements marks a significant shift in regulatory approach to these complex biologic medicines. Biosimilars are cheaper versions of expensive biologic drugs made from living cells, commonly used to treat cancer and autoimmune disorders.

Under the new draft guidance, the FDA is specifically targeting pharmacokinetic studies, which analyze how the body processes a drug. These studies have traditionally been a major expense in biosimilar development, sometimes costing tens of millions of dollars and taking years to complete.

The agency is also withdrawing its 2015 guidance document, stating it no longer reflects current thinking after years of reviewing biosimilar applications. This follows another draft guidance announced in October that aimed at reducing certain efficacy comparison studies, which could take one to three years and cost about $24 million.

Industry experts note that unlike generic versions of simpler chemical drugs, medicines made from living cells cannot be exactly copied, which is why they are termed “biosimilars” rather than generics. The complex nature of these drugs has historically required extensive testing to demonstrate similarity to the original biologic medicine.

The move is part of broader FDA efforts under Commissioner Marty Makary to streamline drug approval processes while maintaining safety standards. This initiative joins other recent policy changes, including the agency’s shift to requiring only one pivotal clinical trial for new drug approvals in many cases.

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