BIOMARIN

BIOMARIN

approved_indications FDA Approved Biologics and Pending Applications

Aldurazyme®

laronidase
BL 125058

Brineura

cerliponase alfa
BL 761052

Naglazyme®

galsulfase
BL 125117

Palynziq®

pegvaliase-pqpz
BL 761079

Roctavian

valoctocogene roxaparvovec-rvox
BL 125720

Vimizim®

elosulfase alfa
BL 125460

approved_indications Inter Partes Review Proceedings

MYOZYME / LUMIZYMEIPR2013-00534
IPR2013-00535
IPR2013-00537

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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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