The European Pharmacopoeia (Ph. Eur.) has published its first monoclonal antibody (mAb) medicinal product monograph for the IgG1-antibody based TNF-alpha antagonist, Golimumab injection (3187).
The European Pharmacopoeia produces monographs for biotherapeutic products that are publicly available and considered the standard for defining the quality of these medicines. The Golimumab injection monograph is included in issue 12.2 of 2025 and become applicable on 1 April 2026.
The monographs and associated physical reference standards of the Ph. Eur. play a major role in ensuring the quality of medicines in Europe and across the globe. First introduced in the 1990s [1], the monographs have encountered challenges related to the advent of biosimilars. As such, there has been a dynamic, collaborative, and transparent dialogue with stakeholders—including representatives from innovator and biosimilar companies, National Control Laboratories, and licensing authorities—on the development of public standards for biotherapeutics [2, 3].
The European Pharmacopoeia Commission (EPC) concluded its pilot phase on monoclonal antibodies (mAbs) in mid-2025 (MAB pilot phase). This initiative aimed to explore the feasibility of establishing Ph. Eur. quality standards for therapeutic mAbs by developing individual monographs for multi-source mAbs (elaboration of monographs via Procedure 1), as well as general chapters to standardise quality attributes common to classes of mAbs. This Golimumab injection monograph is the first individual medicinal product monograph covering a monoclonal antibody and, as such, represents a milestone in the EPC’s mission to develop public standards for this class of biotherapeutics [2].
This Golimumab injection monograph complements the Infliximab concentrated solution (2928) and Adalimumab concentrated solution (3147) monographs, along with 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 were developed as part of the recently concluded MAB pilot phase.
In parallel, an additional monograph, Golimumab concentrated solution (3103), covering another anti-TNF-alpha monoclonal antibody, was developed using the single-source approach. Further monographs are currently in development, including one on a monoclonal antibody targeting a different class of cytokines—interleukins (ustekinumab)—as well as a general chapter on Size-exclusion chromatography for recombinant therapeutic monoclonal antibodies (2.5.43).
Related articles
The European Pharmacopoeia monographs for biotherapeutic products
Non-biological complex drugs and pharmacopoeias
References
1. Charton E. The role of European Pharmacopoeia monographs in setting quality standards for biotherapeutic products. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(4):174-9.doi:10.5639/gabij.2016.0504.045
2. Buda M, Kolaj-Robin O, Charton E. Biotherapeutic products in the European Pharmacopoeia: have all challenges been tackled?. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(4):174-9.doi: 10.5639/gabij.2022.1101.003
3. GaBI Online - Generics and Biosimilars Initiative. Updates for European Pharmacopoeia monographs for biotherapeutic products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 May 6]. Available from: www.gabionline.net/biosimilars/research/updates-for-european-pharmacopoeia-monographs-for-biotherapeutic-products
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