SANDOZ

SANDOZ

approved_indications FDA Approved Biologics and Pending Applications


Erelzi®

etanercept-szzs
aBL 761042

Hyrimoz

adalimumab-adaz
aBL 761071

LA-EP2006

pegfilgrastim
LA-EP2006 Approval Pending

Omnitrope®

somatropin
NDA 021426 [505(b)(2)]

Rixathon®

rituximab
Rixathon® Approval Pending

Zarxio®

filgrastim-sndz
aBL 125553

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In Canada

Erelzi (etanercept) (Sandoz) (April-2017)Omnitrope® (somatropin) (Sandoz) (April-2009)

Biosimilars Approved In The E.U.

Binocrit (epoetin alfa) (Sandoz) (August-2007)Erelzi (etanercept) (Sandoz) (June-2017)Hyrimoz® (adalimumab) (Sandoz) (July-2018)Omnitrope® (somatropin) (Sandoz) (April-2006)Rixathon® (rituximab) (Sandoz) (June-2017) Riximyo (rituximab) (Sandoz) (June-2017)Riximyo (rituximab) (Sandoz) (June-2017)Zarzio (filgrastim) (Sandoz) (February-2009)Zessly (infliximab) (Sandoz) (May-2018

Biosimilars Approved In Australia

Erelzi (etanercept) (Sandoz) (November-2017)Novicrit (epoetin lambda) (Sandoz) (January-2010)Omnitrope® (somatropin) (Sandoz) (September-2010)Riximyo® (rituximab) (Sandoz) (November-2017) Zarzio (filgrastim) (Sandoz) (May-2013)

Biosimilars Approved In Japan

Filgrastim BS (filgrastim) (Sandoz) (March-2014)Somatropin BS (somatropin) (Sandoz) (June-2009)

Biosimilars Approved In South Korea

Omnitrope® (somatropin) (Sandoz) (June-2009)

approved_indications Inter Partes Review Proceedings


HUMIRA / HYRIMOZIPR2017-01823
IPR2017-01824
IPR2017-01987
IPR2017-01988
IPR2017-02105
IPR2017-02106
IPR2018-00002
IPR2018-00156
RITUXAN / RIXATHONIPR2017-02036
IPR2017-02042

approved_indications U.S. Patent Litigations


ENBREL / ERELZI2:16-cv-01118 (D.N.J.)
3:13-cv-02904 (N.D. Cal.)
HUMIRA / HYRIMOZ3:18-cv-12668 (D.N.J.)
NEULASTA / LA-EP20062:16-cv-01276 (D.N.J.)
3:16-cv-02581 (N.D. Cal.)
NEUPOGEN / ZARXIO3:14-cv-04741 (N.D. Cal.)
RITUXAN / RIXATHON / GENENTECH CABILLY1:17-cv-13507 (D.N.J.)

related articles Related News Articles


Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) April M. Breyer Menon; Joseph K. Yarsky; Corinne E. Atton; Robert S. Schwartz, Ph.D. November 30, 2018
Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) April M. Breyer Menon; Corinne E. Atton; Joyce L. Nadipuram; Robert S. Schwartz, Ph.D. November 30, 2018
Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) April M. Breyer Menon; Corinne E. Atton; Joseph K. Yarsky; Robert S. Schwartz, Ph.D. November 30, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – October 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. November 12, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – September 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. October 6, 2018
VIDEO: The BPCIA 1 Year After Sandoz v. Amgen Ha Kung Wong September 19, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – August 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. September 6, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – July 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. August 3, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – June 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. July 6, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – April 2018 April M. Breyer Menon; Corinne E. Atton; Joseph K. Yarsky; Robert S. Schwartz, Ph.D. May 3, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – February 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. March 6, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – November 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. December 5, 2017
VIDEO: Healthcare Reform Efforts and the BPCIA Ha Kung Wong November 28, 2017
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Supreme Court Hears Oral Argument in Sandoz Inc. v. Amgen Inc. Brendan M. O'Malley, Ph.D.; Jacob T. Whitt, Ph.D. April 27, 2017
Approval Biosimilar Notice Implicates Millions Brian L. Klock; Kathryn Easterling August 3, 2016
180-Day Advance Notice Of First Commercial Marketing Is Mandatory For All Biosimilar Applicants Robert S. Schwartz, Ph.D.; Corinne E. Atton; Frederick C. Millett; Erica L. Norey July 7, 2016
The Amgen v. Sandoz BPCIA Decision Stands: the Federal Circuit Denies an En Banc Rehearing Lawrence S. Perry; H. Rachael Million-Perez October 22, 2015
Amgen v. Sandoz: Divided Federal Circuit Attempts to Unravel the BPCIA Alicia A. Russo; Erin J.D. Austin September 1, 2015
Federal Circuit Halts Market Launch of the First U.S. Biosimilar Robert S. Schwartz, Ph.D.; Corinne E. Atton May 12, 2015
The FDA Approves Zarxio® Opening the Door to the U.S. Biosimilars Market Robert S. Schwartz, Ph.D.; Corinne E. Atton March 6, 2015

Methodology

Information contained in the Venable 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 Venable Fitzpatrick BiologicsHQ database.

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