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Declaratory Judgments FDA Approval Pharmaceutical Industry

Venable LLP

Spotlight On: Biosimilar Litigations - June 2025

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Herbert Smith Freehills Kramer

CAR T-Cell Therapy Takes Off and Brings on Patent Litigation

CAR T-Cell therapy, a new biologic therapy, is taking off. As companies continue to develop this new and promising therapy, patent litigation inevitably follows.  ...more

Snell & Wilmer

Supreme Court Permits Biosimilar Drugs to Be Marketed Sooner

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On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more

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