In response to internal FDA reforms, Ha Kung Wong, Molly Burich, Amanda Forys, and Angus Worthing share their expectations concerning review and approval timelines for biosimilar products that are safe, effective, and priced competitively within the market as part of the The Center for Biosimilars™ Peer Exchange®.
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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