Spotlight On: Biosimilar Litigations - April 2026
The article discusses biosimilar litigations and their scope, focusing on disputes between manufacturers and sponsors.
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 litigations between two biosimilar applicants/manufacturers are included. Litigations relating to disputes between two reference product sponsors, or non-practicing entities/universities and reference product sponsors are not included. Litigations related solely to manufacturing... By: Venable LLP
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