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.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
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 | 2024-04-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| polycythemia vera | — | D011087 | D45 |
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
32 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycythemia vera | D011087 | — | D45 | 1 | 4 | 6 | 1 | 1 | 12 |
| Polycythemia | D011086 | EFO_0005804 | D75.1 | 1 | 4 | 6 | 1 | 1 | 12 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | 1 | 1 | 1 | — | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary myelofibrosis | D055728 | — | D47.4 | — | 3 | 1 | — | — | 4 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | — | 1 | — | 1 | 3 |
| Essential thrombocythemia | D013920 | — | D47.3 | — | 1 | 2 | — | — | 3 |
| Thrombocytosis | D013922 | HP_0001894 | D75.83 | — | 1 | 2 | — | — | 3 |
| Hepatitis c | D006526 | — | B19.2 | 1 | 1 | 1 | — | — | 3 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 1 | 1 | 1 | — | — | 3 |
| Infections | D007239 | EFO_0000544 | — | 1 | — | 1 | — | — | 2 |
| Communicable diseases | D003141 | — | — | 1 | — | 1 | — | — | 2 |
| Leukemia | D007938 | — | C95 | 1 | — | 1 | — | — | 2 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis | D006505 | HP_0012115 | K75.9 | 2 | 2 | — | — | 1 | 5 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 2 | 2 | — | — | 1 | 5 |
| Hepatitis d | D003699 | EFO_0007304 | — | 1 | 1 | — | — | — | 2 |
| Carcinoma | D002277 | — | C80.0 | 1 | 1 | — | — | — | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | 1 | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | 1 | — | — | — | 1 |
| Coinfection | D060085 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis b | D006509 | — | — | 1 | — | — | — | 1 | 2 |
| Chronic hepatitis | D006521 | — | K73.9 | 1 | — | — | — | 1 | 2 |
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Chronic hepatitis d | D019701 | — | — | 1 | — | — | — | — | 1 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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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
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Variants
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 139 documents
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Safety
Black-box Warning
Black-box warning for: Besremi
Adverse Events
Top Adverse Reactions
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1,254 adverse events reported
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