Biosimilars in Ireland: HSE best-value biologicals, ustekinumab and aflibercept

What is a biosimilar?

A biosimilar is, in the words of the European Medicines Agency, "a biological medicine highly similar to another biological medicine already approved in the EU (called 'reference medicine') in terms of structure, biological activity and efficacy, safety and immunogenicity profile". The EU approved its first biosimilar in 2006, and the EMA says a biosimilar "is not regarded as a generic of a biological medicine", because living-cell manufacturing cannot copy a protein exactly.

In September 2022 the EMA and the Heads of Medicines Agencies issued a joint statement that biosimilars approved in the EU "are interchangeable from a scientific viewpoint". The EMA adds that "any interchange should only take place after careful consideration of the product information". Source: EMA, Biosimilar medicines: Overview.

Biosimilars in Ireland: the HSE best-value biological programme

Biosimilars in Ireland are steered into use by the HSE Medicines Management Programme (MMP), which reviews every product containing a given molecule and names one or more "best-value biological" (BVB) medicines for prescribers to choose. The MMP states that biosimilar savings "can only be realised by prescribing and utilisation of the recommended BVB medicines".

As listed on the MMP best-value medicines page on 18 October 2026, the current recommendations are:

• Ustekinumab: Imuldosa, Otulfi, Pyzchiva, Steqeyma, Uzpruvo and Wezenla. From 1 July 2026 the HSE reimburses only these for patients starting ustekinumab on the High Tech Arrangement.
• Tocilizumab: Avtozma and Tyenne, with the same new-patient rule from 1 July 2026.
• Filgrastim: Accofil and Tevagrastim.
• Teriparatide: Movymia, Sondelbay, Terrosa and Tetridar, named as best-value medicines; from 1 March 2023 only these are reimbursed for adults starting teriparatide.
• Adalimumab and etanercept: BVB medicines recommended, with patients moved to them since May 2019 (see below).

An evaluation for denosumab 60 mg is under way. The MMP's list of possible 2026 processes (January 2026) also names adalimumab, eculizumab, etanercept, follitropin alfa, golimumab, lipegfilgrastim, liraglutide, pegfilgrastim, somatropin, teriparatide, tocilizumab and ustekinumab. Aflibercept is not on that list, and the MMP had published no aflibercept recommendation by 18 October 2026.

What the HSE says it means for prescribers and patients

For ustekinumab, the MMP recommends that new patients with plaque psoriasis, psoriatic arthritis or Crohn's disease be prescribed a BVB medicine, and that established patients "should be considered for switching to a BVB medicine at the earliest possible opportunity". It cites the EMA and HMA statement in support. Public hospital teams that switch established patients receive a gainshare of €500 of the savings per patient, from 1 January 2026 to 31 December 2026 (MMP letter, 19 December 2025; MMP letter, 24 June 2026).

None of the biosimilars on the HSE Reimbursement List is licensed for ulcerative colitis, so the MMP will consider individual applications for Stelara where that is the indication (MMP reimbursement Q&A, June 2026).

Ustekinumab biosimilars: 11 authorised in the EU

Eleven ustekinumab biosimilars of Stelara hold an EU marketing authorisation, and six of them are HSE best-value biologicals. Three more were authorised and later withdrawn. Stelara itself, held by Janssen-Cilag International NV, was authorised on 16 January 2009. Our drug page for ustekinumab brings together its approvals and trials.

Source: EMA medicines data download, 18 October 2026, and each product's EPAR page ("The reference medicine for ... is Stelara"); HSE status from the MMP best-value medicines page and letters of 19 December 2025, 12 June 2026 and 24 June 2026, plus the Steqeyma evaluation report. The supplier is the company the MMP names in Ireland, which can differ from the EU holder.

Spending explains the attention. The MMP reports High Tech Arrangement expenditure on ustekinumab of about €67.3 million in 2023 and €63.1 million in 2024, with more spent in hospitals (MMP evaluation report, ustekinumab, 27 November 2025). In April 2026, 19% of people receiving ustekinumab on the High Tech Arrangement were prescribed a BVB medicine, against an HSE National Service Plan 2026 target of 80% uptake of BVB medicines (MMP letter, 12 June 2026).

Aflibercept biosimilars: 12 authorised in the EU, none named by the HSE

Twelve biosimilars of Eylea, the aflibercept eye injection held by Bayer AG and authorised in the EU on 21 November 2012, hold an EU marketing authorisation as of 18 October 2026. One more, Skojoy from Amgen Technology (Ireland) UC, received a positive opinion in January 2025 but its application was withdrawn on 12 March 2025. See our aflibercept compound page for trials and approvals.

Source: EMA medicines data download, 18 October 2026, and EPAR pages. Pavblu's date is taken from its EPAR, as the download leaves the field blank; for Ahzantive we use the "marketing authorisation issued" date of 13 January 2025 shown on the EPAR. New authorisations appear in our EMA approvals register.

Adalimumab biosimilars in Ireland: the precedent

Adalimumab, the molecule in Humira, has been in the HSE best-value biological programme since 2019, and its results are the main published Irish evidence for it. A study by Duggan, Smith and Barry of Trinity College Dublin and the MMP found that just over 90 patients had started or switched to a BVB for adalimumab or etanercept by June 2019, rising to over 8,500 a year later (International Journal of Clinical Pharmacy, 2021).

With BVB medicines holding about 50% of the market in June 2020, the authors put combined savings and avoided costs at €22.7 million, and the gainshare had raised over €3.6 million for hospital specialties. By the MMP's later count, over 25,000 patients have started or switched to a biosimilar BVB for adalimumab or etanercept since May 2019. In July 2025, every patient on adalimumab 40 mg pens or syringes on the High Tech Arrangement was on a BVB medicine, 69.5% of them on a biosimilar; for etanercept, 78.6% were on a biosimilar BVB (MMP evaluation report, November 2025).

Ten adalimumab biosimilars hold an EU authorisation today, the first being Amgevita on 21 March 2017; Humira dates from 8 September 2003. More on our adalimumab drug page and etanercept page.

Irish companies behind EU biosimilars

Two companies registered in Ireland hold several of these EU authorisations. Amgen Technology (Ireland) UC holds Wezenla (ustekinumab) and Pavblu (aflibercept); see our Amgen Ireland page. Biosimilar Collaborations Ireland Limited holds Yesintek and Usrenty (ustekinumab), Yesafili (aflibercept) and Hulio (adalimumab). The holder is the legal entity responsible for the medicine in the EU; it does not show where a product is made.

For supply in Ireland, the MMP names a local company for each ustekinumab BVB: Accord Healthcare Ireland Limited, Amgen Ireland Limited, Celltrion Healthcare Ireland Limited, Clonmel Healthcare Limited, Fresenius Kabi Ireland and Sandoz Limited trading as Rowex. In June 2026 the five suppliers then named, all except Celltrion, confirmed to the MMP that they had enough stock for the expected rise in demand.

The US side and how we built this guide

In the United States the FDA licenses biosimilars separately. Our FDA biosimilars register, built from the FDA Purple Book (August 2026 edition, read 27 September 2026), lists eight ustekinumab biosimilar brands, all designated interchangeable, and six aflibercept brands, two of them interchangeable. Patent and exclusivity dates are on our patent expiry tracker, and last year's EU approvals are analysed in our EMA new medicines report.

We filtered the EMA medicines data (18 October 2026) by active substance and biosimilar flag and checked each EPAR; HSE details come from MMP documents. Our methodology page explains the registers, and corrections are logged on our corrections page.