European Pharmacopoeia Commission Concludes Biotherapeutics Pilot Phase

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The commission concluded its P4Bio pilot phase with the adoption of the monograph for etanercept.

The European Pharmacopoeia Commission announced on Dec. 14, 2016 the completion of the pilot phase of its alternative monograph elaboration procedure, P4Bio. The procedure was created to address the patent expiry of biotherapeutics. The P4Bio procedure ensures when a patent on a monograph for first-generation biotherapeutics (e.g., peptide hormones, growth factors, interferons) expires, a public standard for future products is in place. The P4Bio pilot phase concluded when the commission adopted the monograph for Etanercept (2895) during the commission’s November 22–23, 2016 session.

The P4Bio procedure subjects the tests and procedures for a monography to extensive experimental testing by European Phamacopoeia experts from Official Medicines Control Laboratories and by the European Directorate for the Quality of Medicines (EDQM) laboratory. The draft monograph text is then published in the European Pharmacopoeia for public consultation. Four P4Bio monographs have been published in the Ph. Eur.: Insulin glargine (2571), Human coagulation factor VIIa (rDNA) concentrated solution (2534), Human coagulation factor IX (rDNA) concentrated solution (2522), and Teriparatide (2829).

EDQM stated in a


that “the Etanercept monograph is further proof that the standardization challenges related to the complexity and heterogeneity of biotherapeutics can be overcome, so that the monograph specifications are compatible with the development of biosimilars. For example, including process-dependent microheterogeneity (e.g., glycosylation) tests in the Production section adds flexibility to the monograph.”

Source: EDQM