Sandoz Inc

31 products tracked · names used in filings: Sandoz Inc, Sandoz GmbH

Upcoming milestones

No upcoming milestones listed.

Recent milestones

Thu 22 Oct 2026🇺🇸 FDA approval

FDA approves biosimilar Enzeevu (aflibercept-abzv)

Sandoz Inc; BLA761382; Biosimilar; injectable · source

Wed 06 May 2026🇪🇺 EU approval (EC decision)

Bysumlog (insulin lispro) approved in the EU

Marketing authorisation to Sandoz GmbH; Biosimilar, Additional monitoring · source

Mon 27 Apr 2026🇪🇺 EU approval (EC decision)

Dazparda (insulin aspart) approved in the EU

Marketing authorisation to Sandoz GmbH; Biosimilar, Additional monitoring · source

Thu 26 Feb 2026🇪🇺 CHMP positive opinion

Bysumlog (insulin lispro): CHMP positive opinion

Sandoz GmbH; Biosimilar, Additional monitoring · source

Thu 26 Feb 2026🇪🇺 CHMP positive opinion

Dazparda (insulin aspart): CHMP positive opinion

Sandoz GmbH; Biosimilar, Additional monitoring · source

Fri 09 Jan 2026🇪🇺 EU approval (EC decision)

Ondibta (insulin glargine) approved in the EU

Marketing authorisation to Sandoz GmbH; Biosimilar, Additional monitoring · source

Thu 13 Nov 2025🇪🇺 CHMP positive opinion

Ondibta (insulin glargine): CHMP positive opinion

Sandoz GmbH; Biosimilar, Additional monitoring · source

Products

ProductStatusApproved
🇪🇺Dimherity
dimethyl fumarate
Application withdrawn
🇪🇺Zioxtenzo
pegfilgrastim
Application withdrawn
🇪🇺Duloxetine Sandoz
duloxetine
Application withdrawn
🇺🇸Enzeevu
aflibercept-abzv
Approved2026-10-22
🇪🇺Bysumlog
insulin lispro
Authorised2026-05-06
🇪🇺Dazparda
insulin aspart
Authorised2026-04-27
🇪🇺Ondibta
insulin glargine
Authorised2026-01-09
🇪🇺Rolcya
denosumab
Authorised2025-07-17
🇪🇺Afqlir
aflibercept
Authorised2024-11-13
🇪🇺Wyost
denosumab
Authorised2024-05-17
🇪🇺Jubbonti
denosumab
Authorised2024-05-16
🇪🇺Herwenda
trastuzumab
Authorised2023-11-15
🇪🇺Tyruko
natalizumab
Authorised2023-09-22
🇪🇺Ziextenzo
pegfilgrastim
Authorised2018-11-22
🇪🇺Hefiya
adalimumab
Authorised2018-07-26
🇪🇺Hyrimoz
adalimumab
Authorised2018-07-26
🇪🇺Halimatoz
adalimumab
Withdrawn2018-07-26
🇪🇺Zessly
infliximab
Authorised2018-05-18
🇪🇺Erelzi
etanercept
Authorised2017-06-23
🇪🇺Riximyo
rituximab
Authorised2017-06-15
🇪🇺Rixathon
rituximab
Authorised2017-06-15
🇪🇺Pemetrexed Sandoz
pemetrexed
Withdrawn2015-09-18
🇪🇺Aripiprazole Sandoz
aripiprazole
Authorised2015-08-20
🇪🇺Pregabalin Sandoz
pregabalin
Authorised2015-06-19
🇪🇺Pregabalin Sandoz GmbH
pregabalin
Withdrawn2015-06-19
🇪🇺Ibandronic Acid Sandoz
ibandronic acid
Lapsed2011-07-26
🇪🇺Temozolomide Sandoz
temozolomide
Withdrawn2010-03-15
🇪🇺Rivastigmine Sandoz
rivastigmine
Authorised2009-12-10
🇪🇺Zarzio
filgrastim
Authorised2009-02-06
🇪🇺Binocrit
epoetin alfa
Authorised2007-08-28
🇪🇺Omnitrope
somatropin
Authorised2006-04-12

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.