VIDEO: Inspection Reports and Proprietary Information

Following the FDA’s new agreement to share full inspection reports related to biosimilar manufacturing sites to the European Medicines Agency, Ha Kung Wong, Molly Burich, and Amanda Forys remark on industry concerns surrounding confidentiality as part of the The...

VIDEO: Biosimilar Interchangeability and Market Share

Watch Ha Kung Wong, Amanda Forys, and Molly Burich discuss the question, “Will biosimilar manufacturers seeking interchangeability have an effect on how reference product sponsors attempt to protect market share?” as part of the The Center for Biosimilars™...

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). 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 (www.fda.gov). 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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