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New monograph on a single-source anti-TNF-alpha monoclonal antibody released for public consultation in Pharmeuropa

European Pharmacopoeia
12 July 2021
Strasbourg, France

A new draft monograph, Golimumab concentrated solution (3103), has been published in this quarter’s issue of Pharmeuropa (33.3), the European Pharmacopoeia (Ph. Eur.) online forum for comment.

Following the adoption and publication of the monographs for Etanercept (2895) and Infliximab concentrated solution (2928) – the first monographs on anti-tumour necrosis factor-alpha (TNF-alpha) therapeutics – and the ongoing work related to the new general chapter on Cell-based assays for potency determination of TNF-alpha antagonists (2.7.26), the Ph. Eur. Commission has continued developing further quality standards for anti-TNF-alpha products. This has resulted in the elaboration of an individual monograph for the IgG1-antibody based drug, golimumab, another of the five approved anti-TNF-alpha antagonists. The new draft monograph has been elaborated using the single-source approach and reflects the considerations outlined in the EDQM’s scientific publication on Elaborating European Pharmacopoeia monographs for biotherapeutic proteins using substances from a single source.

All interested parties are invited to review the draft monograph and submit their comments on its technical content. In addition, the Ph. Eur. sees this new monograph as an opportunity to reiterate the approach taken for the development of individual monographs for monoclonal antibodies. The EDQM also looks forward to receiving general stakeholder feedback, confirming the success of this way forward.

The deadline for comments is 30 September 2021.

Comments from within the member states are to be sent to the responsible national pharmacopoeial authority; comments from countries outside the Ph. Eur. convention or from industry associations may be sent to the European Directorate for the Quality of Medicines & HealthCare (EDQM) via the EDQM HelpDesk.

For more information on how to comment, please consult our guide.

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