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
| Product | Status | Approved | |
|---|---|---|---|
| 🇪🇺 | Pebrilzo pertuzumab | Opinion | |
| 🇪🇺 | Fubelv etanercept | Authorised | 2026-04-23 |
| 🇪🇺 | Usrenty ustekinumab | Authorised | 2025-09-17 |
| 🇪🇺 | Vivlipeg pegfilgrastim | Authorised | 2025-08-18 |
| 🇪🇺 | Evfraxy denosumab | Authorised | 2025-06-30 |
| 🇪🇺 | Vevzuo denosumab | Authorised | 2025-06-25 |
| 🇪🇺 | Yesintek ustekinumab | Authorised | 2025-02-14 |
| 🇪🇺 | Yesafili aflibercept | Authorised | 2023-09-15 |
| 🇪🇺 | Abevmy bevacizumab | Authorised | 2021-04-21 |
| 🇪🇺 | Kirsty (previously Kixelle) insulin aspart | Authorised | 2021-02-05 |
| 🇪🇺 | Nepexto etanercept | Authorised | 2020-05-20 |
| 🇪🇺 | Ogivri trastuzumab | Authorised | 2018-12-12 |
| 🇪🇺 | Fulphila pegfilgrastim | Authorised | 2018-11-20 |
| 🇪🇺 | Hulio adalimumab | Authorised | 2018-09-17 |
| 🇪🇺 | Semglee insulin glargine | Authorised | 2018-03-23 |
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.