PH1005
Research-stage proposed biosimilar candidate referencing infliximab
Development code
PH1005
Reference molecule
Infliximab
Molecular target
TNF-α
Therapeutic area
Immunology
Scientific Profile
PH1005 is a research-stage proposed biosimilar candidate referencing infliximab. The intended molecule is a recombinant chimeric human/murine IgG1 monoclonal antibody directed against human tumour necrosis factor alpha (TNF-α). Planned development activities include mammalian-cell culture process development and stepwise comparative analytical and functional studies. Biosimilarity has not been established.
Development Focus
Development is focused on comparative characterization of molecular structure, glycosylation, charge and size variants, purity, aggregates, stability, binding to soluble and transmembrane TNF-α, inhibition of TNF-receptor engagement, and cell-based neutralization of TNF-α signalling. Transmembrane-TNF-related and Fc-mediated functional assays will be included where their criticality is scientifically supported. The reference-product context includes multiple immune-mediated inflammatory diseases. These are not established indications for PH1005.
Proposed Mode of Action
PH1005 is designed to bind both soluble and transmembrane forms of TNF-α and inhibit their functional interaction with cell-surface TNF receptors. It is not intended to target lymphotoxin-alpha, also known as TNF-β. If confirmed through comparative studies, TNF-α neutralization would be expected to attenuate TNF-mediated inflammatory signalling in relevant experimental systems. No therapeutic effect has been established for PH1005.
- PH1005 is a research-stage proposed biosimilar candidate. Biosimilarity, safety, efficacy, approved indications, and interchangeability, where such a designation exists, have not been established for PH1005, and PH1005 has not been approved by any regulatory authority. References to the reference medicine, its mechanism of action, and its authorized indications are provided solely for scientific context and do not imply the same characteristics, clinical profile, or regulatory status for PH1005.
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