BIOGEN

BIOGEN

approved_indications FDA Approved Biologics and Pending Applications


Avonex®

interferon beta-1a
BL 103628

Plegridy®

peginterferon beta-1a
BL 125499

Tysabri®

natalizumab
BL 125104

Zinbryta®

daclizumab
BL 761029

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Benepali (etanercept) (Samsung Bioepis / Biogen) (January-2016)

approved_indications Inter Partes Review Proceedings


RITUXANIPR2015-00415
IPR2015-00418
IPR2015-01744
IPR2016-01614
IPR2017-01093
IPR2017-01094
IPR2017-01095
IPR2017-01115
IPR2017-01166
IPR2017-01167
IPR2017-01168
IPR2017-01227
IPR2017-01229
IPR2017-01230
IPR2017-02126
IPR2017-02127
IPR2018-00086
IPR2018-00186
IPR2018-00231
IPR2018-00285
TYSABRIIPR2016-00912
IPR2016-00915
IPR2016-00916
RITUXAN / TRUXIMAIPR2015-01744
IPR2016-01614
IPR2017-01093
IPR2017-01094
IPR2017-01095
IPR2017-01227
IPR2017-01229
IPR2017-01230

approved_indications U.S. Patent Litigations


ACTIVASE / CATHFLO ACTIVASE / AVASTIN / HERCEPTIN / PULMOZYME / RITUXAN / TNKASE / XOLAIR3:08-cv-04909 (N.D. Cal.)
3:09-cv-04919 (N.D. Cal.)
AVONEX / BETASERON / EXTAVIA / REBIF2:10-cv-02734 (D.N.J.)
2:10-cv-02760 (D.N.J.)
RITUXAN / RIXATHON / GENENTECH CABILLY1:17-cv-13507 (D.N.J.)
RITUXAN / TRUXIMA / GENENTECH CABILLY1:18-cv-00574 (D.N.J.)
1:18-cv-11553 (D.N.J.)
4:18-cv-00276 (N.D. Cal.)
SOLIRIS / SYNAGIS / TYSABRI1:11-cv-00084 (D. Del.)

related articles Related News Articles


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
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
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

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.

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