A “Method of Use” to Prevent Generic and Biosimilar Market Entry

A critical pathway that generics and biosimilars manufacturers have used to circumvent patent thickets has been “skinny labeling.” But a recent court ruling has placed this pathway under threat.

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Bibliographische Detailangaben
Veröffentlicht in:	The New England journal of medicine 2023-02, Vol.388 (6), p.483-485
Hauptverfasser:	Tu, S. Sean, Sarpatwari, Ameet
Format:	Artikel
Sprache:	eng
Schlagworte:	and the FDA Biological products Biosimilar Pharmaceuticals - economics Biosimilar Pharmaceuticals - therapeutic use Brand names Devices Drug Costs Drug Industry - economics Drug Industry - legislation & jurisprudence Drugs Drugs, Generic - economics Drugs, Generic - therapeutic use Economic Competition - economics Economic Competition - legislation & jurisprudence FDA approval Federal court decisions Generic drugs Health Law Health Policy Heart failure Humans Hypertension Infringement Labeling Manufacturers Market entry Patents as Topic - legislation & jurisprudence Pharmaceutical industry
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Beschreibung
Zusammenfassung:	A critical pathway that generics and biosimilars manufacturers have used to circumvent patent thickets has been “skinny labeling.” But a recent court ruling has placed this pathway under threat.
ISSN:	0028-4793 1533-4406
DOI:	10.1056/NEJMp2216020