Ropeginterferon alfa-2b
As of the edition of 20 October 2026, Ropeginterferon alfa-2b is a protein: marketed, first approved in 2019 (EU); acts on IFNAR1 and IFNAR2; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Protein
- Brand name
- Besremi
- First approved
- 15 February 2019 (EU)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- PharmaEssentia; 4 holders in all
- Registered trials
- 38, 2 stopped early
- Disease areas
- Blood and lymph; Cancer; Infections; Digestive system; Lungs and airways; Immune system
US protection
US protection ends in 2033.
US protection ends in 2033, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by PharmaEssentia. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 0 | 2 | 0 |
| Phase 1 | 7 | 5 | 2 | 0 |
| Phase 2 | 15 | 4 | 7 | 1 |
| Phase 3 | 12 | 6 | 5 | 0 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 38 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| PharmaEssentia | Applicant and Lead sponsor of trials | 2009 to now |
| AOP Orphan Pharmaceuticals | Applicant and Lead sponsor of trials | 2010 to now |