Semaglutide products
Semaglutide products invited for prequalification are listed in the Invitation to Manufacturers of medicinal products for management of diabetes
Semaglutide Biotherapeutic Products (BTPs) or the corresponding Similar biotherapeutic Products (SBPs), that have been approved by a stringent regulatory authority (SRA)/WHO listed authority (WLA) and are marketed in the country of registration, will be assessed via an Abridged Assessment pathway in line with the guideline for human insulin products.
The Abridged Assessment will include verification of the data submitted by the applicant to demonstrate that the product submitted for WHO prequalification is the same as the product approved by the SRA or WLA. In addition, the applicant should provide evidence that the product proposed for prequalification under this procedure adheres to the principles laid out in the WHO guidelines on the international packaging and shipping of vaccines and meets relevant operational packaging and presentation specifications.
Semaglutide SBPs that have not been registered by SRAs/WLAs will be assessed via a Full Assessment pathway, in accordance with, among other documents, the WHO Procedure for Prequalification of BTPs or their corresponding SBPs (issues originally for human insulin products) and the WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products for rituximab and trastuzumab.
https://extranet.who.int/prequal/sites/default/files/document_files/01_Pilot_PQ_procedure_insulin_Feb2020.pdf
https://extranet.who.int/prequal/sites/default/files/document_files/02_Pilot_PQ_anticancer_fullPathway_20Feb2020.pdf
Semaglutide formulations developed as synthetic peptides and submitted for prequalification via the abridge assessment pathway, the dossier submission should be made based on the guidelines for human insulin products approved by SRAs/WLAs.
https://extranet.who.int/prequal/sites/default/files/document_files/03_GLs_Submission_SBP_Pilot_AbridgedPathway_insulinFeb2020.pdf
Semaglutide formulations developed as synthetic peptides and submitted for prequalification via the full assessment pathway, the dossier submission should be made based on the generic guideline (Annex 4, TRS 970 and Annex 15, TRS 961). Additional product specific guidelines will be issued in due course.
https://iris.who.int/server/api/core/bitstreams/d0447d6c-418e-435d-96d0-5a081498f153/content