MYLAN

MYLAN

approved_indications FDA Approved Biologics and Pending Applications


Fulphila®

pegfilgrastim-jmdb
aBL 761075

Hulio®

adalimumab-fkjp
aBL 761154

M710

aflibercept
M710 Approval Pending

Miacalcin®

calcitonin salmon
BL 20313 [BL 017808]

MYL-1402O

bevacizumab
MYL-1402O Approval Pending

Ogivri®

trastuzumab-dkst
aBL 761074

Semglee®

insulin glargine-yfgn
aBL 210605 / aBL 761201

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)Hulio® (adalimumab) (Mylan / Fujifilm Kyowa Kirin Biologics) (September-2018)Nepexto (etanercept) (Mylan / Lupin) (June-2020)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

Adalimumab BS (adalimumab) (Fujifilm Kyowa Kirin Biologics / Mylan) (June-2020)

Biosimilars Approved In South Korea

Ogivri® (trastuzumab) (Alvogen Korea) (August-2020)

approved_indications Inter Partes Review Proceedings


GENENTECH CABILLYIPR2016-00710
ORENCIAIPR2015-01537
EYLEA / M710IPR2021-00880
IPR2021-00881
IPR2022-01225
IPR2022-01226
IPR2023-00099
IPR2023-00442
HERCEPTIN / OGIVRIIPR2016-01693
IPR2016-01694
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
IPR2019-01657
IPR2019-01658

approved_indications U.S. Patent Litigations


EYLEA / M7101:22-cv-00061 (N.D.W.Va.)
LANTUS / LANTUS SOLOSTAR / SEMGLEE2:17-cv-09105 (D.N.J.)
NEULASTA / FULPHILA2:17-cv-01235 (W.D. Pa.)

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