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Information contained in the Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book. Product and Company page search results are reported for FDA-approved indications, aBLA and 505(b)(2) activity, approved foreign biosimilars, IPRs and U.S. litigations.

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METHODOLOGY

Information contained in the Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

DISCLAIMER

BiologicsHQ and materials published on BiologicsHQ are published for informational purposes only. Neither the information nor any opinion expressed on BiologicsHQ constitute legal advice, create an attorney-client relationship, or constitute a solicitation for business. Links or references to third party sites or resources are provided for informational purposes only.

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