Drug intelligence / Profile preview

Alpheon

Development stage
Discontinued
Lead developer
BioPartners Holdings
Modality
Recombinant Proteins and Enzymes
Administration
Subcutaneous, Intramuscular
01

Overview

Alpheon is a biosimilar version of interferon alfa-2a, originally developed by BioPartners GmbH (which was later acquired by Bioton SA) for the treatment of chronic hepatitis C. It was designed as a biosimilar to Roche's reference product, Roferon-A. The drug is a recombinant protein produced in *Escherichia coli* that acts as an agonist of the type I interferon receptor (IFNAR). By binding to IFNAR, it stimulates the JAK-STAT signaling pathway, leading to the induction of interferon-stimulated genes (ISGs) that provide antiviral, antiproliferative, and immunomodulatory effects. In June 2006, the European Medicines Agency (EMA) rejected the marketing authorization application for Alpheon due to major quality concerns, differences in impurity profiles, and clinical data showing higher rates of disease relapse and more side effects compared to the reference medicine.

Brand names
Alpheon
Other names
interferon alfa-2a biosimilarrecombinant interferon alfa-2a
02

Targets

IFNAR (Immune system modulation via type I interferon receptor)

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