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Interferon-β (IFN-β)

Interferon-β (IFN-β)

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Modality

Interferon-β (IFN-β)

Interferons (INFs) are cytokines secreted during the early stages of viral infection that have antiviral and antiproliferative effects. INFs include three categories, namely IFN-α, IFN-β, and IFN-γ. IFN-α and IFN-β have similar amino acid sequences, associated with the same cellular receptors, and therefore have analogous biological effects, particularly antiviral infection and antiproliferative effects for tumor cells. And recombinant IFN-β has been approved for the treatment of relapsing forms of multiple sclerosis.

INFs are usually produced in Escherichia coli (E. coli) and are currently used in clinical practice as it does not need to undergo posttranslational modification to exhibit biological activity.

Application of Interferon-β (IFN-β)
Interferon beta-1b

Produced using recombinant DNA techniques, betaseron (Interferon beta-1b, IFN-β-1b) is a purified, sterile, lyophilized protein product. Interferon-β-1b, produced by bacterial differentiation of an E. coli strain, carrys a genetically engineered plasmid bearing the gene for human interferon betaser17. The native gene is derived from human fibroblasts and modified by replacing cystine (Cys) with serine (Ser) at position 17. Interferon beta-1b contains 165 amino acids and has a molecular weight of approximately 18.5 kDa. And betaseron was developed by and originally approved by FDA in 1993.

Subsequently, Novartis acquired the marketing rights to the Betaseron replica and paid royalties to Bayer. Extavia, a new formulation of IFN-beta-1b, was approved by the European Medical Agency (EMA) in May 2008 and by the US Food and Drug Administration (FDA) in August 2009 as a biosimilar for human use. It is recombinant formulation of IFN-β1b produced from a strain of E. coli through genetic engineering.

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Interferon-β (IFN-β) Pipelines

Generic Name

Brand Name/

Alternative Name

Expression System

Indications

Manufacturer

R&D Stage

Recombinant interferon β-1b

Betaseron, 倍泰龙

Escherichia coli (E. coli)

Multiple sclerosis (MS)

Bayer AG

Approval

Recombinant human interferon β-1b

Extavia, ベタフェロン

E. coli

Multiple sclerosis (MS)

Novartis AG

Approval

interferon β-1b

Actoferon

Pending update

Multiple sclerosis (MS)

AMEGA Biotech

Approval

interferon β-1b

Pending update

Pending update

Multiple sclerosis (MS)

Biocad

Approval

Recombinant human interferon β-1b

Pending update

Pending update

Multiple sclerosis (MS)

International Biotech Center Generium

Approval

interferon β-1b

Pending update

Pending update

Multiple sclerosis (MS)

Pressure BioSciences

Phase III

interferon β-1b

Rec Hu-IFN beta 1a-44 microgram, ReciGen

Pending update

Multiple sclerosis (MS)

CinnaGen

Phase III

interferon β-1b

Pending update

Pending update

Multiple sclerosis (MS)

Probiomed SA de CV

Approval

interferon β-1b

Pending update

Pending update

Multiple sclerosis (MS)

Bio-Ker s.r.l.

Pre-clinical

Polyethylene glycol recombinant interferon β

Peginterferon beta

Pending update

Multiple sclerosis (MS)

Merck, Ambrx Biopharma

Pre-clinical

Recombinant human interferon β-1a

Blastoferon

Pending update

Multiple sclerosis (MS)

Biosidus

Approval

Recombinant human interferon β-1a

Interferon beta-1a, PLEGRIDY, BG-9418, Avonex, アボネックス

CHO cell

Multiple sclerosis (MS)

Biogen,  Inc., Eisai Co.,

Approval

Polyethylene glycol recombinant interferon β-1a

Peginterferon beta-1a, Plegridy, BIIB-017

CHO cell

Multiple sclerosis (MS)

Biogen,  Inc., Eisai Co.,  Ltd., UCB SA

Approval

Recombinant human interferon β-1a

REBIF

CHO cell

Multiple sclerosis (MS)

Merck, FLAMEL IRELAND LTD, Serono Pharma Schweiz, Pfizer

Approval

interferon β-1a

Pending update

Pending update

Multiple sclerosis (MS)

Insight Biopharmaceuticals Ltd.

Approval

interferon β-1a

Xerfelan

Pending update

Multiple sclerosis (MS)

Landsteiner Scientific SA de CV

Approval

Recombinant human interferon β-1a

Interferon beta-1a

Pending update

Multiple sclerosis (MS)

Reliance Life Sciences

Approval

interferon β-1a

Pending update

Pending update

Multiple sclerosis (MS)

Probiomed SA de CV

Approval

Peginterferon beta-1a

Cinnaferon

Pending update

Multiple sclerosis (MS)

CinnaGen

Phase III

interferon β-1a

FP-1201, FP-1201-lyo, MR-11A8, Traumakine

Pending update

Multiple sclerosis (MS)

Lee's Pharmaceutical

Phase III

Sampeginterferon beta-1a

TENEXIA, BCD 054, BCD-054

Pending update

Multiple sclerosis (MS)

Biocad

Phase III

interferon β-1b

Pending update

Pending update

Multiple sclerosis (MS)

Pfenex,  Inc.

Phase I

Interferon beta-1a extended release

Pending update

Pending update

Multiple sclerosis (MS)

Weizmann Institute of Science

Phase I

Recombinant human interferon β-1a

Interferon beta-1a

Pending update

Multiple sclerosis (MS)

CinnaGen

Phase I

Pegylated interferon β

TRK-560, PEG-IFN-beta

Pending update

Multiple sclerosis (MS)

Toray Industries,  Inc.

Phase I

BBT-012

long-acting interferon beta 1b, BBT-032

Pending update

Multiple sclerosis (MS)

Bolder BioTechnology

Pre-clinical

Interferon beta biobetter

Interferon-β, ABN101

Pending update

Multiple sclerosis (MS)

ABION,  Inc.

Pre-clinical

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