New monographs on an anti-interleukin monoclonal antibody released for public consultation

The European Pharmacopoeia (Ph. Eur.) has published two new draft monographs, Ustekinumab concentrated solution (3165) and Ustekinumab injection (3188), for public comment in this quarter’s issue of Pharmeuropa (36.3).

Following the adoption and publication of the monographs for Etanercept (2895), Infliximab concentrated solution (2928) and Golimumab concentrated solution (3103), as well as the ongoing elaboration of a new monograph for Adalimumab concentrated solution (3147), the European Pharmacopoeia Commission (EPC) has continued to build upon its work in the field of therapeutic monoclonal antibodies (mAbs) – to date, predominantly focussing on TNF-alpha inhibitors -- and embarked on the development of standards for a mAb that targets another type of cytokines (i.e. interleukins (IL)), thereby addressing different complexities. Two new draft monographs for ustekinumab, a first-in-class therapeutic human IgG1 kappa mAb that binds to IL-12 and IL-23, have been established using the single-source approach and reflect the considerations outlined in the EDQM’s scientific publication on Elaborating European Pharmacopoeia monographs for biotherapeutic proteins using substances from a single source. A first wave of biosimilar product approvals for ustekinumab has been recorded, with more biosimilars under development.

All interested parties are invited to review the drafts and submit comments on their technical content, via the appropriate channel. Stakeholder input will be key to refining and evolving the proposed monograph specifications, and to ensuring that they are and remain fit-for-purpose in a rapidly evolving multi-product market.

The same issue of Pharmeuropa contains another new draft monograph, Golimumab injection (3187), the first text on a medicinal product comprising the active substance described in Golimumab concentrated solution (3103), recently published in Ph. Eur. Supplement 11.6. Ustekinumab concentrated solution (3165) and Ustekinumab injection (3188) therefore form the second such “pair” of monographs for application in this dynamic field.

The commenting period runs until 30 September 2024.

More information on how to comment can be found here: “Comment on drafts (Pharmeuropa)”

Source from EDQM: https://www.edqm.eu/en/-/new-monographs-on-an-anti-interleukin-monoclonal-antibody-released-for-public-consultation

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