‘Patent Dance’ Delays Biosimilars Despite FDA Shift
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by Arthur Allen
November 17, 2025
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9 min
The FDA's recent changes aim to accelerate the approval process for biosimilars, which are cheaper alternatives to biologic drugs for conditions like arthritis and cancer. On October 29, FDA Commissioner Marty Makary announced plans that could reduce the cost and time needed for these medications to enter the market by adopting a regulatory approach similar to generics. However, challenges remain, particularly with patent obstacles imposed by the U.S. patent office, which could hinder biosimilar manufacturers from successfully bringing their products to market.
1. FDA plans to expedite biosimilar drug approval. 2. Biosimilars can cost up to 90% less than brand-name drugs. 3. Patent challenges complicate market entry for biosimilars. 4. FDA regulation changes may reduce necessary clinical trials. 5. Only 5% of prescriptions are for biologic drugs yet they cost half of U.S. drug expenditure.
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