Biosimilars in the United Kingdom
Every biosimilar licensed in the United Kingdom, with its presentations, from the MHRA product lists.
Regulator: Medicines and Healthcare products Regulatory Agency
MHRAproducts approved110
MHRAmolecules with a biosimilar26
About biosimilars in the United Kingdom
The MHRA licenses medicines for Great Britain, while Northern Ireland follows EU licences. Biosimilars approved in the EU before 2021 became UK licences automatically, and since then new products have been approved by relying on EMA or FDA decisions, so the UK list closely follows the European one, with a few products that exist only here. The MHRA product lists give each product's name and presentations but not its holder, licence number or approval date, so the UK entries on this page show what is licensed rather than when. There is no interchangeable designation; the MHRA considers approved biosimilars interchangeable with their reference, and switching is decided by prescribers and the NHS.
By molecule
Products approved per molecule.
Denosumab11Teriparatide9Adalimumab8Aflibercept8Bevacizumab8Ustekinumab8Pegfilgrastim6Ranibizumab6Trastuzumab6Enoxaparin sodium5Filgrastim4Rituximab4Tocilizumab4Etanercept3Infliximab3Eculizumab2Epoetin alfa and zeta2Follitropin alfa2Insulin aspart2Insulin glargine2Omalizumab2Golimumab1Insulin lispro1Natalizumab1Pertuzumab1Somatropin1
Every record
| Molecule | Brand | Developer | Holder or applicant | Approved | Application or permission | Status |
|---|---|---|---|---|---|---|
| Adalimumab | Amgevita | Amgen | Not shown in the MHRA substance list | not shown | not published | Approved |
| Adalimumab | Hukyndra | Alvotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Adalimumab | Hulio | Fujifilm Kyowa Kirin Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Adalimumab | Hyrimoz | Sandoz | Not shown in the MHRA substance list | not shown | not published | Approved |
| Adalimumab | Idacio | Fresenius Kabi | Not shown in the MHRA substance list | not shown | not published | Approved |
| Adalimumab | Imraldi | Samsung Bioepis | Not shown in the MHRA substance list | not shown | not published | Approved |
| Adalimumab | Yuflyma | Celltrion | Not shown in the MHRA substance list | not shown | not published | Approved |
| Adalimumab | Qletli | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Aflibercept | Afqlir | Sandoz | Not shown in the MHRA substance list | not shown | not published | Approved |
| Aflibercept | Ahzantive | Formycon | Not shown in the MHRA substance list | not shown | not published | Approved |
| Aflibercept | Eydenzelt | Celltrion | Not shown in the MHRA substance list | not shown | not published | Approved |
| Aflibercept | Mynzepli | Alvotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Aflibercept | Opuviz | Samsung Bioepis | Not shown in the MHRA substance list | not shown | not published | Approved |
| Aflibercept | Pavblu | Amgen | Not shown in the MHRA substance list | not shown | not published | Approved |
| Aflibercept | Vgenfli | Sam Chun Dang Pharm | Not shown in the MHRA substance list | not shown | not published | Approved |
| Aflibercept | Yesafili | Biocon Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Bevacizumab | Abevmy | Biocon Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Bevacizumab | Alymsys | mAbxience | Not shown in the MHRA substance list | not shown | not published | Approved |
| Bevacizumab | Oyavas | mAbxience | Not shown in the MHRA substance list | not shown | not published | Approved |
| Bevacizumab | Aybintio | Samsung Bioepis | Not shown in the MHRA substance list | not shown | not published | Approved |
| Bevacizumab | Vegzelma | Celltrion | Not shown in the MHRA substance list | not shown | not published | Approved |
| Bevacizumab | Zirabev | Pfizer | Not shown in the MHRA substance list | not shown | not published | Approved |
| Bevacizumab | Ankevda | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Bevacizumab | Bevqolva | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Bevacizumab | Versavo | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Acvybra | Alvotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Xbonzy | Alvotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Zvogra | Alvotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Kefdensis | Alvotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Bildyos | Shanghai Henlius Biotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Bilprevda | Shanghai Henlius Biotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Bomyntra | Fresenius Kabi | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Conexxence | Fresenius Kabi | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Denbrayce | mAbxience | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Izamby | mAbxience | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Zadenvi | mAbxience | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Enwylma | mAbxience | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Evfraxy | Biocon Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Vevzuo | Biocon Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Jubbonti | Sandoz | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Wyost | Sandoz | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Jubereq | Intas Pharmaceuticals | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Osvyrti | Intas Pharmaceuticals | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Junod | Gedeon Richter | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Yaxwer | Gedeon Richter | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Obodence | Samsung Bioepis | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Xbryk | Samsung Bioepis | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Osenvelt | Celltrion | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Stoboclo | Celltrion | Not shown in the MHRA substance list | not shown | not published | Approved |
| Denosumab | Ponlimsi | Teva | Not shown in the MHRA substance list | not shown | not published | Approved |
| Eculizumab | Bekemv | Amgen | Not shown in the MHRA substance list | not shown | not published | Approved |
| Eculizumab | Epysqli | Samsung Bioepis | Not shown in the MHRA substance list | not shown | not published | Approved |
| Enoxaparin sodium | Inhixa | Techdow | Not shown in the MHRA substance list | not shown | not published | Approved |
| Enoxaparin sodium | Ledraxen | Not stated in the EDE directory | Not shown in the MHRA substance list | not shown | not published | Approved |
| Enoxaparin sodium | Arovi | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Enoxaparin sodium | Crusia | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Enoxaparin sodium | Ghemaxan | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Epoetin alfa and zeta | Abseamed | Sandoz | Not shown in the MHRA substance list | not shown | not published | Approved |
| Epoetin alfa and zeta | Retacrit | Norbitec | Not shown in the MHRA substance list | not shown | not published | Approved |
| Etanercept | Benepali | Samsung Bioepis | Not shown in the MHRA substance list | not shown | not published | Approved |
| Etanercept | Erelzi | Sandoz | Not shown in the MHRA substance list | not shown | not published | Approved |
| Etanercept | Nepexto | Lupin | Not shown in the MHRA substance list | not shown | not published | Approved |
| Filgrastim | Accofil | Intas Pharmaceuticals | Not shown in the MHRA substance list | not shown | not published | Approved |
| Filgrastim | Nivestim | Pfizer | Not shown in the MHRA substance list | not shown | not published | Approved |
| Filgrastim | Zarzio | Sandoz | Not shown in the MHRA substance list | not shown | not published | Approved |
| Filgrastim | Zefylti | CuraTeQ Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Follitropin alfa | Bemfola | Finox Biotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Follitropin alfa | Ovaleap | Teva | Not shown in the MHRA substance list | not shown | not published | Approved |
| Golimumab | Gobivaz | Alvotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Golimumab | Gotenfia | Alvotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Infliximab | Flixabi | Samsung Bioepis | Not shown in the MHRA substance list | not shown | not published | Approved |
| Infliximab | Inflectra | Celltrion | Not shown in the MHRA substance list | not shown | not published | Approved |
| Infliximab | Remsima | Celltrion | Not shown in the MHRA substance list | not shown | not published | Approved |
| Infliximab | Zessly | Pfizer | Not shown in the MHRA substance list | not shown | not published | Approved |
| Insulin aspart | Kirsty | Biocon Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Insulin aspart | Trurapi | Sanofi | Not shown in the MHRA substance list | not shown | not published | Approved |
| Insulin glargine | Abasaglar | Eli Lilly | Not shown in the MHRA substance list | not shown | not published | Approved |
| Insulin glargine | Semglee | Biocon Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Insulin lispro | Admelog | Sanofi | Not shown in the MHRA substance list | not shown | not published | Approved |
| Natalizumab | Tyruko | Polpharma Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Omalizumab | Omlyclo | Celltrion | Not shown in the MHRA substance list | not shown | not published | Approved |
| Omalizumab | Adcomfo | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Pegfilgrastim | Dyrupeg | CuraTeQ Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Pegfilgrastim | Fulphila | Biocon Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Pegfilgrastim | Grasustek | Juta Pharma | Not shown in the MHRA substance list | not shown | not published | Approved |
| Pegfilgrastim | Pelgraz | Intas Pharmaceuticals | Not shown in the MHRA substance list | not shown | not published | Approved |
| Pegfilgrastim | Pelmeg | Cinfa Biotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Pegfilgrastim | Ziextenzo | Sandoz | Not shown in the MHRA substance list | not shown | not published | Approved |
| Pertuzumab | Poherdy | Shanghai Henlius Biotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ranibizumab | Byooviz | Samsung Bioepis | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ranibizumab | Ranluspec | Lupin | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ranibizumab | Rimmyrah | Qilu Pharmaceutical | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ranibizumab | Ximluci | Xbrane Biopharma | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ranibizumab | Fovlussea | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ranibizumab | Ongavia | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Rituximab | Ituxredi | Dr. Reddy's Laboratories | Not shown in the MHRA substance list | not shown | not published | Approved |
| Rituximab | Rixathon | Sandoz | Not shown in the MHRA substance list | not shown | not published | Approved |
| Rituximab | Ruxience | Pfizer | Not shown in the MHRA substance list | not shown | not published | Approved |
| Rituximab | Truxima | Celltrion | Not shown in the MHRA substance list | not shown | not published | Approved |
| Somatropin | Omnitrope | Sandoz | Not shown in the MHRA substance list | not shown | not published | Approved |
| Teriparatide | Kauliv | Strides Pharma | Not shown in the MHRA substance list | not shown | not published | Approved |
| Teriparatide | Movymia | Gedeon Richter | Not shown in the MHRA substance list | not shown | not published | Approved |
| Teriparatide | Terrosa | Gedeon Richter | Not shown in the MHRA substance list | not shown | not published | Approved |
| Teriparatide | Sondelbay | Intas Pharmaceuticals | Not shown in the MHRA substance list | not shown | not published | Approved |
| Teriparatide | Lusama | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Teriparatide | Teriparatide Teva | Teva | Not shown in the MHRA substance list | not shown | not published | Approved |
| Teriparatide | Teriparatide Sun | Sun Pharmaceutical Industries | Not shown in the MHRA substance list | not shown | not published | Approved |
| Teriparatide | Teriparatide Dr. Reddy's | Dr. Reddy's Laboratories | Not shown in the MHRA substance list | not shown | not published | Approved |
| Teriparatide | Teriparatide Biotech | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Teriparatide | Teriparatide Ambio Pharma | Not stated in the MHRA list | Not shown in the MHRA substance list | not shown | not published | Approved |
| Tocilizumab | Avtozma | Celltrion | Not shown in the MHRA substance list | not shown | not published | Approved |
| Tocilizumab | Tofidence | Bio-Thera Solutions | Not shown in the MHRA substance list | not shown | not published | Approved |
| Tocilizumab | Tuyory | Gedeon Richter | Not shown in the MHRA substance list | not shown | not published | Approved |
| Tocilizumab | Tyenne | Fresenius Kabi | Not shown in the MHRA substance list | not shown | not published | Approved |
| Trastuzumab | Dazublys | CuraTeQ Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Trastuzumab | Herzuma | Celltrion | Not shown in the MHRA substance list | not shown | not published | Approved |
| Trastuzumab | Ogivri | Biocon Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
| Trastuzumab | Ontruzant | Samsung Bioepis | Not shown in the MHRA substance list | not shown | not published | Approved |
| Trastuzumab | Trazimera | Pfizer | Not shown in the MHRA substance list | not shown | not published | Approved |
| Trastuzumab | Zercepac | Shanghai Henlius Biotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ustekinumab | Imuldosa | Dong-A ST | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ustekinumab | Otulfi | Formycon | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ustekinumab | Pyzchiva | Samsung Bioepis | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ustekinumab | Steqeyma | Celltrion | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ustekinumab | Usymro | Gedeon Richter | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ustekinumab | Uzpruvo | Alvotech | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ustekinumab | Wezenla | Amgen | Not shown in the MHRA substance list | not shown | not published | Approved |
| Ustekinumab | Yesintek | Biocon Biologics | Not shown in the MHRA substance list | not shown | not published | Approved |
Last checked Sep 2026.
How MHRA assesses a biosimilar
| Legal pathway | UK marketing authorisation from MHRA. EU approvals in force at the end of 2020 became Great Britain licences automatically; new products since 2021 are approved through reliance on EMA or FDA decisions, and from 2024 through the International Recognition Procedure. Northern Ireland follows EU licences |
|---|---|
| Reference product | Reference biologic authorised in the UK, or an EU-authorised version with bridging data |
| Comparative clinical study | Follows the EU guideline; MHRA's 2021 biosimilar guidance states that a comparative efficacy trial is generally not needed where analytical and pharmacokinetic comparability is shown |
| Interchangeability | No designation; MHRA considers approved biosimilars interchangeable with their reference, and switching is decided by the prescriber and by NHS commissioning |
| Naming | Brand name with the non-proprietary name; licence numbers PL, PLGB or PLNI |
Sources: FDA draft guidance on comparative efficacy studies (October 2025) and interchangeability (June 2024); EMA reflection paper EMA/CHMP/BMWP/60916/2025 (March 2026) and EMA/HMA statement on interchangeability (September 2022); CDSCO Guidelines on Similar Biologics 2016 and 2025 draft (S009, S010); EDE directory (S018); MHLW/PMDA biosimilar guideline and notifications (S021); Health Canada guidance on biosimilar biologic drugs; MHRA guidance on the licensing of biosimilar products (2021).
EvySaif prepares MHRA submissions and regional dossier strategy for biosimilar developers. Regulatory strategy consulting
Sources
S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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