The European Pharmacopoeia (Ph. Eur.) has continued to build upon its work in the field of therapeutic monoclonal antibodies with the publication of its first monoclonal antibody (mAb) medicinal product monograph, for the IgG1-antibody based TNF-alpha antagonist, Golimumab injection (3187). The new monograph is included in European Pharmacopoeia (Ph. Eur.) Issue 12.2, released in October 2025.
This monograph joins Infliximab concentrated solution (2928), as well as the general chapters on Cell-based assays for potency determination of TNF-alpha antagonists (2.7.26) and Capillary isoelectric focusing for recombinant therapeutic monoclonal antibodies (2.5.44), all three of which were elaborated as part of the recently concluded MAB pilot phase. An additional monograph, Golimumab concentrated solution (3103), for another anti-TNF-alpha monoclonal antibody, was developed in parallel but using the single-source approach. Individual monographs on a TNF-alpha antagonist (adalimumab) and on a mAb that targets a different type of cytokines, i.e. interleukins (ustekinumab), as well as a general chapter on Size-exclusion chromatography for recombinant therapeutic monoclonal antibodies (2.5.43) are also in the pipeline.
As the first individual medicinal product monograph covering a monoclonal antibody, Golimumab injection constitutes another milestone in the European Pharmacopoeia Commission’s commitment to developing public standards for this class of biotherapeutics. The new monograph will come into force on 1 April 2026.
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