BIOCON

BIOCON

approved_indications FDA Approved Biologics and Pending Applications

Fulphila®

pegfilgrastim-jmdb
aBL 761075

MYL-1402O

bevacizumab
MYL-1402O Approval Pending

Ogivri

trastuzumab-dkst
aBL 761074

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Fulphila® (pegfilgrastim) (Mylan / Biocon) (May-2019) Ogivri (trastuzumab) (Mylan / Biocon) (May-2019)

Biosimilars Approved In The E.U.

Fulphila® (pegfilgrastim) (Mylan / Biocon) (November-2018)Kixelle (insulin aspart) (Viatris / Biocon) (February-2021)Ogivri (trastuzumab) (Mylan / Biocon) (December-2018)Semglee (insulin glargine) (Mylan / Biocon) (March-2018)

Biosimilars Approved In Australia

Fulphila® (pegfilgrastim) (Alphapharm / Mylan / Biocon) (August-2018)Ogivri (trastuzumab) (Mylan / Biocon) (December-2018) Semglee (insulin glargine) (Mylan / Biocon) (March-2018)

Biosimilars Approved In Japan

Insulin glargine BS (insulin glargine) (Biocon / Fujifilm Pharma) (March-2016)

approved_indications Inter Partes Review Proceedings

GENENTECH CABILLYIPR2016-00710
LANTUS / LANTUS SOLOSTAR / SEMGLEEIPR2017-01526
IPR2017-01528
IPR2018-01670
IPR2018-01675
IPR2018-01676
IPR2018-01677
IPR2018-01678
IPR2018-01679
IPR2018-01680
IPR2018-01682
IPR2018-01684
IPR2018-01696
IPR2019-00122

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Venable Fitzpatrick’s BiologicsHQ Monthly Injection – March 2020 April Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D.; Ha Kung Wong April 8, 2020
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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 – June 2018 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. July 6, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – December 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. January 8, 2018
Venable Fitzpatrick’s BiologicsHQ Monthly Injection – July 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. July 26, 2017

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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