Biosimilar Collaborations Ireland Limited

15 products tracked · names used in filings: Biosimilar Collaborations Ireland Limited

Upcoming milestones

No upcoming milestones listed.

Recent milestones

Thu 23 Apr 2026🇪🇺 EU approval (EC decision)

Fubelv (etanercept) approved in the EU

Marketing authorisation to Biosimilar Collaborations Ireland Limited; Biosimilar, Additional monitoring · source

Thu 26 Feb 2026🇪🇺 CHMP positive opinion

Fubelv (etanercept): CHMP positive opinion

Biosimilar Collaborations Ireland Limited; Biosimilar, Additional monitoring · source

Products

ProductStatusApproved
🇪🇺Pebrilzo
pertuzumab
Opinion
🇪🇺Fubelv
etanercept
Authorised2026-04-23
🇪🇺Usrenty
ustekinumab
Authorised2025-09-17
🇪🇺Vivlipeg
pegfilgrastim
Authorised2025-08-18
🇪🇺Evfraxy
denosumab
Authorised2025-06-30
🇪🇺Vevzuo
denosumab
Authorised2025-06-25
🇪🇺Yesintek
ustekinumab
Authorised2025-02-14
🇪🇺Yesafili
aflibercept
Authorised2023-09-15
🇪🇺Abevmy
bevacizumab
Authorised2021-04-21
🇪🇺Kirsty (previously Kixelle)
insulin aspart
Authorised2021-02-05
🇪🇺Nepexto
etanercept
Authorised2020-05-20
🇪🇺Ogivri
trastuzumab
Authorised2018-12-12
🇪🇺Fulphila
pegfilgrastim
Authorised2018-11-20
🇪🇺Hulio
adalimumab
Authorised2018-09-17
🇪🇺Semglee
insulin glargine
Authorised2018-03-23

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.