“Streamlined labeling” is a strategy where subsequent drug producers seek authorization for only a selection of the uses for which the original patented drugs have been sanctioned.
Through the introduction of competition between five biological medications and their streamlined-label biosimilar counterparts, Medicare witnessed a conservation of $1.5 billion from 2015 to 2020.
Existing court judgments are poised to impinge on those aforementioned savings for Medicare and the accessibility of said biosimilars along with others via streamlined labeling, as indicated in a study accessible online within JAMA Internal Medicine.
In the face of ongoing efforts to implore the US Supreme Court to uphold a legal principle that permits generic pharmaceutical manufacturers to distribute a patent-protected brand medication for particular uses under a “streamlined” label, recent investigations present apprehensions regarding the potential forfeiture of billions in savings should the judiciary decline to safeguard streamlined biosimilar labels.
