SANDOZ

SANDOZ

approved_indications FDA Approved Biologics and Pending Applications

BAT1706

bevacizumab
BAT1706 Approval Pending

EG12014

trastuzumab
EG12014 Approval Pending

Erelzi®

etanercept-szzs
aBL 761042

GP2411

denosumab
GP2411 Approval Pending

Hyrimoz

adalimumab-adaz
aBL 761071

Omnitrope®

somatropin
aBL 021426

PB006

natalizumab
PB006 Approval Pending

Rixathon®

rituximab
Rixathon® Approval Pending

Zarxio®

filgrastim-sndz
aBL 125553

Ziextenzo®

pegfilgrastim-bmez
aBL 761045

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Erelzi (etanercept) (Sandoz) (April-2017)Hyrimoz® (adalimumab) (Sandoz Canada) (November-2020)Omnitrope® (somatropin) (Sandoz) (April-2009)Riximyo® (rituximab) (Sandoz) (April-2020) Ziextenzo® (pegfilgrastim) (Sandoz) (April-2020)

Biosimilars Approved In The E.U.

Binocrit (epoetin alfa) (Sandoz) (August-2007)Erelzi (etanercept) (Sandoz) (June-2017)Hyrimoz® (adalimumab) (Sandoz) (July-2018 low-concentration, April-2023 high-concentration)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-2018Ziextenzo® (pegfilgrastim) (Sandoz) (November-2018)

Biosimilars Approved In Australia

Erelzi (etanercept) (Sandoz) (November-2017)Hyrimoz® (adalimumab) (Sandoz) (May-2019)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

SKYRIZIPGR2022-00037
HUMIRA / HYRIMOZIPR2017-01823
IPR2017-01824
IPR2017-01987
IPR2017-01988
IPR2017-02105
IPR2017-02106
IPR2018-00002
IPR2018-00156
RITUXAN / RIXATHONIPR2017-02036
IPR2017-02042
TYSABRI / PB006PGR2022-00054

approved_indications U.S. Patent Litigations

ENBREL / ERELZI2:16-cv-01118 (D.N.J.)
3:13-cv-02904 (N.D. Cal.)
ENBREL / ETICOVO2:19-cv-11755 (D.N.J.)
HUMIRA / HYRIMOZ3:18-cv-12668 (D.N.J.)
NEULASTA / ZIEXTENZO2:16-cv-01276 (D.N.J.)
3:16-cv-02581 (N.D. Cal.)
3:19-cv-00977 (N.D. Cal.)
NEUPOGEN / ZARXIO3:14-cv-04741 (N.D. Cal.)
3:19-cv-00977 (N.D. Cal.)
NEUPOGEN / ZARXIO / NEULASTA / ZIEXTENZO3:19-cv-00977 (N.D. Cal.)
PROLIA / XGEVA / GP24111:23-cv-02406 (D.N.J.)
RITUXAN / RIXATHON / GENENTECH CABILLY1:17-cv-13507 (D.N.J.)
TYSABRI / PB0061:22-cv-01190 (D. Del.)

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.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

    captcha