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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 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 patents that may be relevant to multiple products (for example, U.S. Patent Nos. 6,331,415, 7,923,221, and 4,816,567 (“Cabilly Patents”)) also are not included.


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    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


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