MHRA Updates on Biosimilar Initiatives, Adds Ocrevus, Amends Lynkuet Variation

We use some essential cookies to make this website work. We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. We also use cookies set by other sites to help us deliver content from their services. You have accepted additional cookies. You can change your cookie settings at any time. You have rejected additional cookies. You can change your cookie settings at any time. Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products. Ocrevus (ocrelizumab) added Amended to add type-II variation to Lynkuet (elinzanetant) Updated document to add new updated NAS EoI form Added 'Dupixent (dupilumab)' to 'Overview of MHRA NASWSI approvals' table. Ekterly (sebetralstat) added to the overview of MHRA NASWSI approvals table. Lynkuet (elinzanetant) added to the overview of MHRA NASWSI approvals table. Update to the The Operational Procedures attachment to include the latest version. Added another row for Nemluvio Changed to resolve table layout issue with Opsumit and to add Andembry Added Opsumit (macitentan) to Naswsi Approvals table Fruzaqla (fruquintinib) added to approvals list Product Vabysmo (faricimab) added to the overview of MHRA NASWSI approvals table. The table has been updated to add a new product: Brukinsa (zanubrutinib). Updated the Operational Procedures for the New Active Substance Work Sharing Initiative (NASWSI). Overview of MHRA NASWSI approvals section added. Added the Expression of Interest (EOI) form. The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success. By engaging in these partnerships, Access is able to co-ordinate regulatory review procedures, and increase each agency’s capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products. The Operational Procedures for the New Active Substance Work Sharing Initiative (NASWSI) ( PDF , 340 KB , 13 pages ) contains further details on this procedure. The applicant should first express interest in the initiatives by using the NAS Expression of Interest Form ( MS Word Document , 169 KB ) or Biosimilar Expression of Interest (EOI) form ( MS Word Document , 177 KB ) to the relevant authorities. This should be done 3 - 6 months before the target submission date. The applicant must then submit identical dossiers (while taking country-specific aspects into account) to the relevant authorities participating in the work sharing initiative. Where possible, this should be done within a time frame of two weeks. The application to the MHRA must be in eCTD format and in accordance with UK regulatory requirements . Modules 2 to 5 do not have to be identical across countries, but it is preferable that the same dossiers are submitted to all the participating regulators. Where there are differences, the ‘Summary of differences between dossiers’ (included in the EOI form) should be completed outlining the differences in information provided to each regulator. Each authority reviews the module or modules allocated to it for the main review. As soon as the main review of all modules is concluded, the evaluation reports will be shared via a secure IT platform. Modules will be peer reviewed by those participating authorities that have not conducted the initial main review. The authorities will then discuss the results in a teleconference and prepare a consolidated response to be communicated to the applicant. Product labelling will not be part of the joint review process. There may be discussions among regulators about product labelling during the assessment phase, however regulators will review and determine this on a national basi