The European Pharmacopoeia (Ph. Eur.) has published a new draft monograph, Adalimumab concentrated solution (3147), for public comment in this quarter’s issue of Pharmeuropa (37.3).

Adalimumab is a widely used therapeutic human IgG1 kappa monoclonal antibody. It targets tumour necrosis factor alpha (TNF-α) – a key mediator in inflammatory responses – and is used to treat conditions such as rheumatoid arthritis and psoriasis.

Given its therapeutic importance and the numerous biosimilars available across Ph. Eur. member states, the European Pharmacopoeia Commission (EPC) decided to elaborate an adalimumab monograph using the multi-source approach (Procedure 1). This ensures that the resulting standard can be applied by manufacturers of both originator and biosimilar products.

The elaboration of the adalimumab monograph builds on the EPC’s broader efforts to define quality standards for anti-TNF-α biotherapeutics. It complements existing Ph. Eur. texts, including monographs on etanercept, infliximab and golimumab, as well as general chapter 2.7.26. Cell-based assays for potency determination of TNF-alpha antagonists.

Comments from interested parties from member states of the European Pharmacopoeia Convention should be sent to the responsible national pharmacopoeia authority (NPA); comments from other countries or from industry associations should be sent to the European Directorate for the Quality of Medicines & HealthCare (EDQM) via the EDQM HelpDesk.

Stakeholder input will be key to the process of refining the proposed monograph specifications in order to ensure they are fit for purpose.

📘 Access the draft monograph in Pharmeuropa 37.3

🗓️ Deadline for comments: 30 September 2025

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