# Ropeginterferon alfa-2b

Ropeginterferon alfa-2b (Besremi, AOP Orphan Pharmaceuticals GmbH) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Myeloproliferative neoplasms

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Any line | Polycythaemia vera only; Without symptomatic splenomegaly |

## Products

### Besremi

- Company: AOP Orphan Pharmaceuticals GmbH
- Target: Interferon alfa receptor agonist
- ATC: L03AB15
- EU approval: 15 Feb 2019
- Label revised: 24 Apr 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/besremi-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/besremi-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/besremi

Mechanism (SmPC section 5.1): Binds to the interferon alfa receptor (IFNAR), activating downstream JAK/STAT signaling to inhibit proliferation of hematopoietic progenitor cells and reduce JAK2V617F allele burden.

## Label wording

- **Ropeginterferon alfa-2b** (Besremi), Myeloproliferative neoplasms, any line: “Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/besremi-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/ropeginterferon-alfa-2b