Besremi(ropeginterferon alfa-2b)
Besremi (ropeginterferon alfa-2b) is an unknown pharmaceutical. Ropeginterferon alfa-2b was first approved as Besremi on 2019-02-15. It is used to treat polycythemia vera in the USA. It has been approved in Europe to treat polycythemia vera.
Download report
Favorite
Commercial
Trade Name
FDA
EMA
Besremi
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Ropeginterferon alfa-2b
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Besremi | ropeginterferon alfa-2b-njft | PharmaEssentia | N-761166 RX | 2021-11-12 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| besremi | Biologic Licensing Application | 2021-12-08 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ropeginterferon alfa-2b, Besremi, PharmaEssentia Corporation | |||
| 2028-11-12 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
25 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycythemia vera | D011087 | D45 | 1 | 5 | 2 | — | — | 7 | |
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 1 | — | 1 | — | 1 | 3 |
| Essential thrombocythemia | D013920 | D47.3 | — | 1 | 1 | — | — | 2 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 1 | 1 | — | — | — | 2 |
| Primary myelofibrosis | D055728 | D47.4 | — | 2 | — | — | — | 2 | |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | 1 | — | — | — | 1 |
| Hepatitis d | D003699 | EFO_0007304 | — | 1 | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | ROPEGINTERFERON ALFA-2B |
| INN | ropeginterferon alfa-2b |
| Description | Ropeginterferon alfa-2b, sold under the brand name Besremi, is a medication used to treat polycythemia vera. It is an interferon. It is given by injection.
|
| Classification | Protein |
| Drug class | PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1335098-50-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297819 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15119 |
| UNII ID | 981TME683S (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 1 documents
View more details
Safety
Black-box Warning
Black-box warning for: Besremi
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
3,031 adverse events reported
View more details
Premium feature
Learn more about premium features at pharmakb.com
Learn more