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MHRA adds Icotyde (icotrokinra) to NASWSI approvals list on Access work-sharing guidance page

🇬🇧 MHRA · Tue 27 Oct 2026

The UK regulator updated its Access work-sharing guidance on 27 October 2026, adding icotrokinra to the table of products approved through the New Active Substance Work Sharing Initiative.

The MHRA has updated its guidance page on the Access Consortium's New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI). The latest change, dated 27 October 2026, adds Icotyde (icotrokinra) to the table of MHRA NASWSI approvals.

It follows a 14 October 2026 addition of Onswik (insulin efsitora alfa) to the same table. The page's change log also records Ocrevus (ocrelizumab) being added on 1 October 2026, and an amendment on 9 July 2026 adding a type-II variation to Lynkuet (elinzanetant). A new NAS expression of interest form was added on 30 January 2026.

The page also restates how the procedure works. Applicants should submit an expression of interest 3 to 6 months before the target submission date, then file identical dossiers, taking country-specific aspects into account, with the participating authorities, ideally within two weeks. The MHRA submission must be in eCTD format and meet UK requirements.

Each authority reviews its allocated modules, evaluation reports are shared via a secure IT platform, and the regulators hold a teleconference to prepare a consolidated response. Labelling is not part of the joint review and is decided nationally. Each regulator keeps its own decision-making independence, so approval or refusal by one does not necessarily affect the others. National fees apply.

What it means for your team

  • Sponsors can use the approvals table to see which new active substances have already reached a UK positive outcome through NASWSI.
  • Teams planning work-sharing filings should plan expressions of interest 3 to 6 months before target submission and use the current NAS form.
  • Labelling and external assessment summaries remain national, so UK-specific product information and PAR processes still need separate planning.
  • Decision timing can differ between Access regulators, so UK launch planning should not assume simultaneous outcomes.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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