Brand-name, biologic makers’ “patent thickets,” accumulating patents based on small changes to the original product, have bogged down biosimilar launches in the U.S., the paper argues.
Although the FDA has approved 20 biosimilars, only seven are available for patient use in the U.S.
“This is a direct result of the patent schemes used by some brand-name pharmaceutical companies to maintain their lucrative product pricing monopolies beyond the period Congress deemed reasonable,” the paper claims.
To estimate the cost of the delayed biosimilar entry to patients and payers, AAM and the Biosimilars council calculated foregone savings for the 12 biosimilars that currently remain off the market due to patent thickets, assuming they would have been launched after receiving FDA approval.
Access the full paper here.
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