Biosimilars in United Arab Emirates
Biosimilars registered with the Emirates Drug Establishment, with manufacturer, UAE supplier and registration date from the EDE directory.
Regulator: Emirates Drug Establishment
EDEproducts registered35
EDEmolecules with a biosimilar17
By molecule
Products registered per molecule.
Pegfilgrastim5Adalimumab4Trastuzumab4Bevacizumab3Denosumab3Rituximab3Enoxaparin sodium2Filgrastim2Infliximab2Ustekinumab2Epoetin alfa and zeta1Etanercept1Follitropin alfa1Insulin aspart1Insulin glargine1Ranibizumab1Somatropin1
Every record
| Molecule | Brand | Developer | Holder or applicant | Registered | Application or permission | Status |
|---|---|---|---|---|---|---|
| Adalimumab | Hyrimoz | Sandoz | Novartis Pharmaceutical Manufacturing GmbH (Sandoz) | Oct 2019 | not published | Registered |
| Adalimumab | Idacio | Fresenius Kabi | Fresenius Kabi Austria GmbH | Mar 2024 | not published | Registered |
| Adalimumab | Hulio | Fujifilm Kyowa Kirin Biologics | Terumo Yamaguchi Corporation for Biocon Biologics | May 2025 | not published | Registered |
| Adalimumab | Amgevita | Amgen | Amgen Europe B.V. | not published | not published | Registered |
| Bevacizumab | Mvasi | Amgen | Amgen Technology (Ireland) Unlimited Company | Apr 2020 | not published | Registered |
| Bevacizumab | Zirabev | Pfizer | Pfizer Service Company BVBA, Belgium | Dec 2020 | not published | Registered |
| Bevacizumab | Abevmy | Biocon Biologics | Biocon Biologics Limited, India | Feb 2022 | not published | Registered |
| Denosumab | Osvyrti | Intas Pharmaceuticals | Accord Healthcare Limited, United Kingdom | Sep 2025 | not published | Registered |
| Denosumab | Jubereq | Intas Pharmaceuticals | Accord Healthcare Limited, United Kingdom | Sep 2025 | not published | Registered |
| Denosumab | Jubbonti | Sandoz | Novartis Pharmaceutical Manufacturing GmbH (Sandoz) | Jun 2026 | not published | Registered |
| Enoxaparin sodium | Inhixa | Techdow | SciencePharma Sp. z o.o., Poland (for Techdow) | Jun 2019 | not published | Registered |
| Enoxaparin sodium | Ledraxen | Not stated in the EDE directory | Centre Specialites Pharmaceutiques, France | Oct 2021 | not published | Registered |
| Epoetin alfa and zeta | Binocrit | Sandoz | Sandoz GmbH TechOps, Austria | Sep 2018 | not published | Registered |
| Etanercept | Erelzi | Sandoz | Novartis Pharmaceutical Manufacturing GmbH (Sandoz) | Apr 2020 | not published | Registered |
| Filgrastim | Zarzio | Sandoz | Novartis Pharmaceutical Manufacturing GmbH (Sandoz) | Mar 2015 | not published | Registered |
| Filgrastim | TevaGrastim | Teva | Teva Pharmaceutical Industries, Israel | Jun 2022 | not published | Registered |
| Follitropin alfa | Bemfola | Finox Biotech | Gedeon Richter Plc., Hungary | Sep 2016 | not published | Registered |
| Infliximab | Remsima | Celltrion | Hikma Pharmaceuticals, Jordan (for Celltrion) | Jun 2017 | not published | Registered |
| Infliximab | Renflexis | Samsung Bioepis | Samsung Bioepis NL B.V. | Oct 2021 | not published | Registered |
| Insulin aspart | Kirsty | Biocon Biologics | Biocon Sdn. Bhd., Malaysia | Jul 2023 | not published | Registered |
| Insulin glargine | Semglee | Biocon Biologics | Biocon Sdn. Bhd., Malaysia | Aug 2021 | not published | Registered |
| Pegfilgrastim | Biopegfil | Biocon Biologics | Biocon Biologics Limited, India | Feb 2019 | not published | Registered |
| Pegfilgrastim | Fulphila | Biocon Biologics | Biocon Biologics Limited, India (country of origin Ireland) | Nov 2019 | not published | Registered |
| Pegfilgrastim | Ziextenzo | Sandoz | Novartis Pharmaceutical Manufacturing GmbH (Sandoz) | Oct 2020 | not published | Registered |
| Pegfilgrastim | Pelgraz | Intas Pharmaceuticals | Accord Healthcare Limited, United Kingdom | Dec 2021 | not published | Registered |
| Pegfilgrastim | Nyvepria | Pfizer | Hospira Zagreb d.o.o. (Pfizer) | May 2024 | not published | Registered |
| Ranibizumab | Ximluci | Xbrane Biopharma | STADA Arzneimittel AG, Germany | Dec 2023 | not published | Registered |
| Rituximab | Rixathon | Sandoz | Lek Pharmaceuticals d.d., Slovenia (Sandoz) | Mar 2019 | not published | Registered |
| Rituximab | Truxima | Celltrion | Hikma Pharmaceuticals, Jordan (for Celltrion) | Apr 2020 | not published | Registered |
| Rituximab | Ruxience | Pfizer | Pfizer Manufacturing Belgium NV | Feb 2021 | not published | Registered |
| Somatropin | Omnitrope | Sandoz | Novartis Pharmaceutical Manufacturing GmbH (Sandoz) | May 2014 | not published | Registered |
| Trastuzumab | Ogivri | Biocon Biologics | Biocon Biologics Limited, India | Nov 2018 | not published | Registered |
| Trastuzumab | Kanjinti | Amgen | Amgen Europe B.V. | Feb 2019 | not published | Registered |
| Trastuzumab | Herzuma | Celltrion | Hikma Pharmaceuticals, Jordan (for Celltrion) | Apr 2020 | not published | Registered |
| Trastuzumab | Trazimera | Pfizer | Pfizer Manufacturing Belgium NV | Apr 2020 | not published | Registered |
| Ustekinumab | Wezenla | Amgen | Amgen Technology (Ireland) Unlimited Company | Oct 2024 | not published | Registered |
| Ustekinumab | Imuldosa | Dong-A ST | Accord Healthcare Limited, United Kingdom | May 2025 | not published | Registered |
Records checked against EDE's files, Sep 2026.
How EDE assesses a biosimilar
| Legal pathway | Registration through the Emirates Drug Establishment; the public directory does not distinguish biosimilars from other biologicals |
|---|---|
| Reference product | Not stated in the public directory; registration relies on assessment by reference regulators |
| Comparative clinical study | Assessed on the dossier accepted by the reference regulator |
| Interchangeability | Not defined |
| Naming | Brand name as registered |
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.
EvySaif prepares EDE submissions and regional dossier strategy for biosimilar developers. Regulatory strategy consulting
Sources
S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)
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