BIOGEN

FDA Approved Biologics and Pending Applications

Aduhelm®

aducanumab-avwa
BL 761178

Avonex®

interferon beta-1a
BL 103628

Byooviz

ranibizumab-nuna
aBL 761202

Plegridy®

peginterferon beta-1a
BL 125499

Tofidence

tocilizumab-bavi
aBL 761354

Tysabri®

natalizumab
BL 125104

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Byooviz (ranibizumab) (Samsung Bioepis / Biogen) (March-2022)

Biosimilars Approved In The E.U.

Benepali (etanercept) (Samsung Bioepis / Biogen) (January-2016)Byooviz (ranibizumab) (Samsung Bioepis / Biogen) (August-2021)Opuviz (aflibercept) (Samsung Bioepis / Biogen) (November-2024)Tofidence (tocilizumab) (Biogen / Bio-Thera) (June-2024)

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
PGR2022-00054
RITUXAN / RUXIENCEIPR2017-01115
IPR2017-01166
IPR2017-01167
IPR2017-01168
IPR2017-02126
IPR2017-02127
IPR2018-00086
IPR2018-00186
IPR2018-00231
IPR2018-00285
RITUXAN / TRUXIMAIPR2015-01744
IPR2016-01614
IPR2017-01093
IPR2017-01094
IPR2017-01095
IPR2017-01227
IPR2017-01229
IPR2017-01230
TYSABRI / TYRUKOPGR2022-00054

U.S. Patent Litigations

ADUHELM1:20-cv-10543 (D. Mass.)
ACTEMRA / TOFIDENCE1:23-cv-11573 (D. Mass.)
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 / DRL_RI1:23-cv-22485 (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.)
TYSABRI / TYRUKO1:22-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.

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