Denosumab biosimilars
An antibody that slows bone loss, used for osteoporosis and for cancer that has spread to bone, and the molecule with the most new biosimilars in 2025.
About denosumab
Denosumab is an antibody that stops the cells which break down bone from forming and working. It is used at a low dose for osteoporosis and at a high dose for cancer that has spread to bone, and the two uses are sold under different brand names.
Bone is constantly built up and broken down. Denosumab blocks a signal called RANK ligand that the body uses to switch on the bone-removing cells. With that signal blocked, bone loss slows and bone density rises.
For osteoporosis it is an injection under the skin every six months. For cancer patients it is a larger injection every four weeks. Because the two doses are separate products, each biosimilar usually appears under two brand names, one for each use.
Osteoporosis in women after the menopause and in men, bone loss caused by hormone treatment for cancer, prevention of fractures and other bone problems in patients whose cancer has spread to bone, and giant cell tumour of bone.
Denosumab biosimilars are compared in the laboratory, in healthy volunteers using a blood marker of bone turnover, and in a clinical study of bone density in women with osteoporosis over a year. Immune reactions to the drug are rare.
The reference products are Prolia and Xgeva, both from Amgen. Their patents expired in the United States and Europe in 2025, and many biosimilars were approved within a few months.
More denosumab biosimilars were approved in 2025 than of any other molecule in a single year. Ten companies gained US approval within eighteen months, nearly all with interchangeable status, and the European list is longer still. The science is well understood, so companies compete on speed, price and having both presentations. India's first permission came in 2018, well ahead of the West.
Clinical details are summarised from the reference product's prescribing information. Approval dates, numbers and presentations are in the tables below, each with its source.
Competitive outlook
- Today17 denosumab biosimilars are approved in at least one of the seven markets.
- With regulators nowDenosumab Ascend, EU application 006710, EU application 006719 are under review. A decision usually comes within a year.
- Nearest to marketArylia, CMAB807, LY06006 have reached phase 3, the last trial before a filing.
- Further outMW032 is still at the pharmacokinetic stage, usually two to three years from any approval.
- If all of them arriveThe approved count would rise from 17 to 24. The applications under review are anonymous in the EMA list and are probably some of the same candidates, so 21 is the more realistic figure.
No published switching study for this molecule yet.
Approvals by year
Regulatory register
| Regulator | Brand | Holder or applicant | Approved | Application or permission | US licence | Status | Source |
|---|---|---|---|---|---|---|---|
| FDA | Jubbonti | Sandoz Inc. | Mar 2024 | 761362 | Interchangeable | Approved | S001, S016 |
| FDA | Wyost | Sandoz Inc. | Mar 2024 | 761362 | Interchangeable | Approved | S001, S016 |
| FDA | Ospomyv | Samsung Bioepis Co., Ltd. | Feb 2025 | 761392 | Interchangeable | Approved | S001, S016 |
| FDA | Xbryk | Samsung Bioepis Co., Ltd. | Feb 2025 | 761392 | Interchangeable | Approved | S001, S016 |
| FDA | Stoboclo | CELLTRION, Inc. | Feb 2025 | 761404 | Interchangeable | Approved | S001, S016 |
| FDA | Osenvelt | CELLTRION, Inc. | Feb 2025 | 761404 | Interchangeable | Approved | S001, S016 |
| FDA | Conexxence | Fresenius Kabi USA, LLC | Mar 2025 | 761398 | Interchangeable | Approved | S001, S016 |
| FDA | Bomyntra | Fresenius Kabi USA, LLC | Mar 2025 | 761398 | Interchangeable | Approved | S001, S016 |
| FDA | Bildyos | Shanghai Henlius Biotech, Inc. | Aug 2025 | 761444 | Interchangeable | Approved | S001, S016 |
| FDA | Bilprevda | Shanghai Henlius Biotech, Inc. | Aug 2025 | 761444 | Interchangeable | Approved | S001, S016 |
| FDA | Bosaya | Biocon Biologics Inc. | Sep 2025 | 761436 | Interchangeable | Approved | S001, S016 |
| FDA | Aukelso | Biocon Biologics Inc. | Sep 2025 | 761436 | Interchangeable | Approved | S001, S016 |
| FDA | Enoby | Hikma Pharmaceuticals USA Inc. | Sep 2025 | 761439 | Interchangeable | Approved | S001, S016 |
| FDA | Xtrenbo | Hikma Pharmaceuticals USA Inc. | Sep 2025 | 761439 | Interchangeable | Approved | S001, S016 |
| FDA | Osvyrti | Accord BioPharma Inc. | Oct 2025 | 761424 | Interchangeable | Approved | S001, S016 |
| FDA | Jubereq | Accord BioPharma Inc. | Oct 2025 | 761424 | Interchangeable | Approved | S001, S016 |
| FDA | Boncresa | Amneal Pharmaceuticals LLC | Dec 2025 | 761456 | Interchangeable | Approved | S001, S016 |
| FDA | Oziltus | Amneal Pharmaceuticals LLC | Dec 2025 | 761457 | Interchangeable | Approved | S001, S016 |
| FDA | Ponlimsi | Teva Pharmaceuticals, Inc. | Mar 2026 | 761385 | Interchangeable | Approved | S001, S016 |
| EMA | Jubbonti | Sandoz GmbH | May 2024 | EMEA/H/C/005964 | Approved | S017 | |
| EMA | Wyost | Sandoz GmbH | May 2024 | EMEA/H/C/006378 | Approved | S017 | |
| EMA | Obodence | Samsung Bioepis NL B.V. | Feb 2025 | EMEA/H/C/006424 | Approved | S017 | |
| EMA | Xbryk | Samsung Bioepis NL B.V. | Feb 2025 | EMEA/H/C/006468 | Approved | S017 | |
| EMA | Stoboclo | Celltrion Healthcare Hungary Kft. | Feb 2025 | EMEA/H/C/006156 | Approved | S017 | |
| EMA | Osenvelt | Celltrion Healthcare Hungary Kft. | Feb 2025 | EMEA/H/C/006157 | Approved | S017 | |
| EMA | Osvyrti | Accord Healthcare S.L.U. | May 2025 | EMEA/H/C/006399 | Approved | S017 | |
| EMA | Jubereq | Accord Healthcare S.L.U. | May 2025 | EMEA/H/C/006398 | Approved | S017 | |
| EMA | Junod | Gedeon Richter Plc. | Jun 2025 | EMEA/H/C/006436 | Approved | S017 | |
| EMA | Yaxwer | Gedeon Richter Plc. | Jun 2025 | EMEA/H/C/006437 | Approved | S017 | |
| EMA | Vevzuo | Biosimilar Collaborations Ireland Limited | Jun 2025 | EMEA/H/C/006534 | Approved | S017 | |
| EMA | Denbrayce | Mabxience Research SL | Jun 2025 | EMEA/H/C/006199 | Approved | S017 | |
| EMA | Izamby | Mabxience Research SL | Jun 2025 | EMEA/H/C/006152 | Approved | S017 | |
| EMA | Zadenvi | Zentiva k.s. | Jun 2025 | EMEA/H/C/006377 | Approved | S017 | |
| EMA | Enwylma | Zentiva k.s. | Jun 2025 | EMEA/H/C/006376 | Approved | S017 | |
| EMA | Evfraxy | Biosimilar Collaborations Ireland Limited | Jun 2025 | EMEA/H/C/006526 | Approved | S017 | |
| EMA | Bomyntra | Fresenius Kabi Deutschland GmbH | Jul 2025 | EMEA/H/C/006269 | Approved | S017 | |
| EMA | Rolcya | Sandoz GmbH | Jul 2025 | EMEA/H/C/006507 | Approved | S017 | |
| EMA | Conexxence | Fresenius Kabi Deutschland GmbH | Jul 2025 | EMEA/H/C/006268 | Approved | S017 | |
| EMA | Bilprevda | Sciencepharma Sp. z o.o | Sep 2025 | EMEA/H/C/006435 | Approved | S017 | |
| EMA | Bildyos | Sciencepharma Sp. z o.o | Sep 2025 | EMEA/H/C/006434 | Approved | S017 | |
| EMA | Vysribli | Intas Third Party Sales 2005 S.L. | Nov 2025 | EMEA/H/C/006797 | Approved | S017 | |
| EMA | Zvogra | Stada Arzneimittel AG | Nov 2025 | EMEA/H/C/006552 | Approved | S017 | |
| EMA | Kefdensis | Stada Arzneimittel AG | Nov 2025 | EMEA/H/C/006490 | Approved | S017 | |
| EMA | Xbonzy | Reddy Holding GmbH | Nov 2025 | EMEA/H/C/006722 | Approved | S017 | |
| EMA | Acvybra | Reddy Holding GmbH | Nov 2025 | EMEA/H/C/006734 | Approved | S017 | |
| EMA | Degevma | Teva GmbH | Nov 2025 | EMEA/H/C/006239 | Approved | S017 | |
| EMA | Ponlimsi | Teva GmbH | Nov 2025 | EMEA/H/C/006238 | Approved | S017 | |
| EMA | Osqay | Theramex Ireland Limited | Jan 2026 | EMEA/H/C/006492 | Approved | S017 | |
| EMA | Denosumab Ascend | Ascend GmbH | opinion Jun 2026 | EMEA/H/C/006626 | Under review | S017 | |
| EMA | Application 006710 | Applicant not yet named by EMA | since Jul 2026 | EMEA/H/C/006710 | Under review | S019 | |
| EMA | Application 006719 | Applicant not yet named by EMA | since Jul 2026 | EMEA/H/C/006719 | Under review | S019 | |
| MHRA | Acvybra | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Xbonzy | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Zvogra | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Kefdensis | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Bildyos | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Bilprevda | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Bomyntra | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Conexxence | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Denbrayce | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Izamby | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Zadenvi | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Enwylma | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Evfraxy | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Vevzuo | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Jubbonti | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Wyost | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Jubereq | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Osvyrti | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Junod | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Yaxwer | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Obodence | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Xbryk | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Osenvelt | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Stoboclo | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ponlimsi | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Denosumab BS 120 mg RM F | Fuji Pharma | Sep 2025 | not published | Approved | S020 | |
| HC | Jubbonti | Sandoz Canada Incorporated | Feb 2024 | DIN 02545411 | Approved | S022 | |
| HC | Wyost | Sandoz Canada Incorporated | Mar 2024 | DIN 02545764 | Approved | S022 | |
| HC | Osenvelt | Celltrion INC. | Sep 2025 | DIN 02560895 | Approved | S022 | |
| HC | Stoboclo | Celltrion INC. | Sep 2025 | DIN 02560917 | Approved | S022 | |
| HC | Bildyos | Shanghai Henlius Biotech, INC. | Mar 2026 | DIN 02565951 | Approved | S022 | |
| HC | Tuzemty | Shanghai Henlius Biotech, INC. | Mar 2026 | DIN 02566001 | Approved | S022 | |
| HC | Denoza | Apotex INC | Mar 2026 | DIN 02566265 | Approved | S022 | |
| CDSCO | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals Ltd | Jan 2018 | MF-284/2017 | Approved | S014 | |
| CDSCO | Enzene Biosciences (INN only) | Enzene Biosciences Ltd | Jul 2021 | MF/BIO/21/000062 | Approved | S011 | |
| CDSCO | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals Ltd | Aug 2021 | MF/BIO/21/000083 | Approved | S011 | |
| CDSCO | Reliance Life Sciences (INN only) | Reliance Life Sciences Pvt Ltd | Dec 2022 | MF/BIO/22/000133 | Approved | S011 | |
| CDSCO | Hetero Biopharma (INN only) | Hetero Biopharma Limited | Dec 2024 | MF/BIO/24/000132 | Approved | S011 | |
| CDSCO | Lupin (INN only) | Lupin Limited | Jun 2026 | MF/BIO/26/000084 | Approved | S011 | |
| EDE | Osvyrti | Accord Healthcare Limited, United Kingdom | Sep 2025 | not published | Registered | S018 | |
| EDE | Jubereq | Accord Healthcare Limited, United Kingdom | Sep 2025 | not published | Registered | S018 | |
| EDE | Jubbonti | Novartis Pharmaceutical Manufacturing GmbH (Sandoz) | Jun 2026 | not published | Registered | S018 |
Last checked Sep 2026. US interchangeability designations are listed in full on the interchangeable biosimilars page. CDSCO lists permissions by firm and INN, not brand. PMDA's list and the UAE directory do not publish application numbers; Canadian dates are the first approval or market date recorded in the Drug Product Database.
Regulatory pathway by market
Requirements for a denosumab biosimilar under the guidance in force in September 2026.
| FDA, United States | EMA, European Union | MHRA, United Kingdom | PMDA, Japan | Health Canada | CDSCO, India | EDE, UAE | |
|---|---|---|---|---|---|---|---|
| Legal pathway | Section 351(k) of the Public Health Service Act (BPCIA 2009) | Article 10(4) of Directive 2001/83/EC; centralised procedure is mandatory for biotechnology products | 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 | MHLW approval on PMDA review under the Guideline for Ensuring Quality, Safety and Efficacy of Biosimilars (2009, revised 2020), with Q&A updates in 2024 and 2026 | Notice of Compliance under the Food and Drug Regulations as a biosimilar biologic drug, assessed under Health Canada's guidance on biosimilars (2016, revised 2022 and 2026) | Guidelines on Similar Biologics (CDSCO and DBT, 2016, in force); revised draft published May 2025 | Registration through the Emirates Drug Establishment; the public directory does not distinguish biosimilars from other biologicals |
| Reference product | US-licensed reference; a non-US comparator may be used with analytical and PK bridging | EU-authorised reference; a non-EEA comparator may be used with bridging data | Reference biologic authorised in the UK, or an EU-authorised version with bridging data | The original biopharmaceutical approved in Japan; foreign-sourced reference accepted with bridging since the 2020 revision | Reference biologic drug authorised in Canada, or a non-Canadian version of it with bridging data | Product licensed in India, or if not, one licensed in an ICH country, with justification | Not stated in the public directory; registration relies on assessment by reference regulators |
| Comparative clinical study | Draft guidance (October 2025): comparative analytical assessment plus a PK similarity study and immunogenicity assessment; a comparative efficacy study is generally not needed | Reflection paper adopted March 2026: a comparative efficacy trial can be waived when analytical and PK comparability is sufficient | 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 | Comparative PK study and, in principle, a comparative efficacy study; the May 2026 early consideration sets out when the efficacy study can be omitted, and Japanese patient data are no longer required in every case (2025) | Comparative structural and functional studies, PK and, where warranted, PD equivalence; the 2026 revision reduces the expectation of comparative efficacy trials in line with FDA and EMA | Comparative PK/PD study and a comparative safety and efficacy study are generally expected, followed by a post-marketing study | Assessed on the dossier accepted by the reference regulator |
| Interchangeability | A separate designation permitting pharmacy-level substitution; switching studies generally not required under the June 2024 draft | EMA and HMA statement (September 2022): EU biosimilars are interchangeable with their reference; substitution rules are set by each member state | No designation; MHRA considers approved biosimilars interchangeable with their reference, and switching is decided by the prescriber and by NHS commissioning | Not defined; prescribing by brand, with pharmacist substitution not automatic | No federal designation; substitution and mandatory switching policies are set by each province, several of which have required switching since 2019 | Not defined in the guidelines | Not defined |
| Naming | INN plus a four-letter suffix | INN, identical to the reference; brand name and batch recorded for pharmacovigilance | Brand name with the non-proprietary name; licence numbers PL, PLGB or PLNI | INN followed by BS (biosimilar), strength, form and the company name in quotation marks, with a biosimilar number in the non-proprietary name | Non-proprietary name identical to the reference, with brand name and DIN as identifiers | INN with the brand name | 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; MHRA guidance on the licensing of biosimilar products (2021).
EvySaif prepares the comparative evidence plan and the regional dossier strategy for denosumab programmes. Regulatory strategy consulting
Presentations and concentration
60 mg/mL is the osteoporosis presentation (Prolia equivalent); 120 mg in 1.7 mL, 70 mg/mL, is the oncology presentation (Xgeva equivalent).
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Jubbonti / Wyost GP2411 | 60 mg/mL PFS; 120 mg/1.7 mL vial | see SmPC | 60 mg syringe; 120 mg | · | 60 mg; 120 mg | · | 60 mg/mL |
| Ospomyv / Xbryk / Obodence SB16 | 60 mg/mL PFS; 120 mg/1.7 mL vial | see SmPC | 60 mg syringe; 120 mg | · | · | · | · |
| Stoboclo / Osenvelt CT-P41 | 60 mg/mL PFS; 120 mg/1.7 mL vial | see SmPC | 120 mg; 60 mg syringe | · | 120 mg; 60 mg | · | · |
| Conexxence / Bomyntra FKS518 | 60 mg/mL PFS; 120 mg/1.7 mL vial | see SmPC | 120 mg syringe and vial; 60 mg syringe | · | · | · | · |
| Osvyrti / Jubereq INTP23 | 60 mg/mL PFS; 120 mg/1.7 mL vial | see SmPC | 120 mg; 60 mg syringe | · | · | 60 mg/mL PFS and vial; 70 mg/mL vial (120 mg) | 60 mg/mL; 120 mg (70 mg/mL) |
| Bosaya / Aukelso / Vevzuo / Evfraxy Bmab 1000 | 60 mg/mL PFS; 120 mg/1.7 mL vial | see SmPC | 60 mg syringe; 120 mg | · | · | · | · |
| Enoby / Xtrenbo / Junod / Yaxwer RGB-14 | 60 mg/mL PFS; 120 mg/1.7 mL vial | see SmPC | 60 mg syringe; 120 mg | · | · | · | · |
| Bildyos / Bilprevda HLX14 | 60 mg/mL PFS; 120 mg/1.7 mL vial | see SmPC | 60 mg syringe; 120 mg | · | 60 mg; 120 mg | · | · |
| Boncresa / Oziltus / Denbrayce / Izamby MB09 | 60 mg/mL PFS; 120 mg/1.7 mL vial | see SmPC | 120 mg; 60 mg syringe | · | · | · | · |
| Ponlimsi / Degevma TVB-009 | 60 mg/mL PFS | see SmPC | 60 mg syringe | · | · | · | · |
| Zvogra / Kefdensis / Xbonzy / Acvybra AVT03 | · | see SmPC | 60 mg syringe; 120 mg | · | · | · | · |
| Osqay / Enzene denosumab | · | see SmPC | · | · | · | 60 mg/mL PFS | · |
| Reliance Life Sciences denosumab | · | · | · | · | · | 60 mg/mL PFS and vial; 120 mg/1.7 mL vial (2025) | · |
| Hetero denosumab | · | · | · | · | · | 120 mg/1.7 mL vial (70 mg/mL) | · |
| Lupin denosumab | · | · | · | · | · | 60 mg/mL PFS | · |
| Denosumab Ascend | · | see SmPC | · | · | · | · | · |
| EU application 006710 | · | see SmPC | · | · | · | · | · |
| EU application 006719 | · | see SmPC | · | · | · | · | · |
| Denosumab BS F | · | · | · | 120 mg vial | · | · | · |
| Denoza | · | · | · | · | 60 mg | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Sandoz | Jubbonti / Wyost | ✓ | ✓ | ✓ | · | ✓ | · | ✓ |
| Samsung Bioepis | Ospomyv / Xbryk / Obodence | ✓ | ✓ | ✓ | · | · | · | · |
| Celltrion | Stoboclo / Osenvelt | ✓ | ✓ | ✓ | · | ✓ | · | · |
| Fresenius Kabi | Conexxence / Bomyntra | ✓ | ✓ | ✓ | · | · | · | · |
| Intas Pharmaceuticals | Osvyrti / Jubereq | ✓ | ✓ | ✓ | · | · | ✓ | ✓ |
| Biocon Biologics | Bosaya / Aukelso / Vevzuo / Evfraxy | ✓ | ✓ | ✓ | · | · | · | · |
| Gedeon Richter | Enoby / Xtrenbo / Junod / Yaxwer | ✓ | ✓ | ✓ | · | · | · | · |
| Shanghai Henlius Biotech | Bildyos / Bilprevda | ✓ | ✓ | ✓ | · | ✓ | · | · |
| mAbxience | Boncresa / Oziltus / Denbrayce / Izamby | ✓ | ✓ | ✓ | · | · | · | · |
| Teva | Ponlimsi / Degevma | ✓ | ✓ | ✓ | · | · | · | · |
| Alvotech | Zvogra / Kefdensis / Xbonzy / Acvybra | · | ✓ | ✓ | · | · | · | · |
| Enzene Biosciences (Alkem) | Osqay / Enzene denosumab | · | ✓ | · | · | · | ✓ | · |
| Reliance Life Sciences | Reliance Life Sciences denosumab | · | · | · | · | · | ✓ | · |
| Hetero Biopharma | Hetero denosumab | · | · | · | · | · | ✓ | · |
| Lupin | Lupin denosumab | · | · | · | · | · | ✓ | · |
| Ascend | Denosumab Ascend | · | review | · | · | · | · | · |
| Applicant not yet named by EMA | EU application 006710 | · | review | · | · | · | · | · |
| Applicant not yet named by EMA | EU application 006719 | · | review | · | · | · | · | · |
| Fuji Pharma | Denosumab BS F | · | · | · | ✓ | · | · | · |
| Apotex | Denoza | · | · | · | · | ✓ | · | · |
Entering a market where a competitor is already listed changes the evidence and pricing conversation. EvySaif's global value dossier and HTA submission work covers that side.
Products
Jubbonti / Wyost
Ospomyv / Xbryk / Obodence
Stoboclo / Osenvelt
Conexxence / Bomyntra
Osvyrti / Jubereq
Bosaya / Aukelso / Vevzuo / Evfraxy
Enoby / Xtrenbo / Junod / Yaxwer
Bildyos / Bilprevda
Boncresa / Oziltus / Denbrayce / Izamby
Ponlimsi / Degevma
Zvogra / Kefdensis / Xbonzy / Acvybra
Osqay / Enzene denosumab
Reliance Life Sciences denosumab
Hetero denosumab
Lupin denosumab
Denosumab Ascend
EU application 006710
EU application 006719
Denosumab BS F
Denoza
In development
ClinicalTrials.gov holds eighteen comparative trials of twelve denosumab biosimilar candidates against the reference product, run by twelve sponsors. Four of the candidates (Arylia, CMAB807, LY06006, MW032) have no approval yet in any of the seven markets, so they show where the next competition may come from. Trials are listed with the sponsor's own wording for status and dates.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | In the Atlas | Registry record |
|---|---|---|---|---|---|---|---|---|---|
| AVT03 | Alvotech | Prolia | Phase 3 | Comparative efficacy | Completed | Aug 2022 | May 2024 | Zvogra / Kefdensis / Xbonzy / Acvybra | NCT05395091 |
| AVT03 | Alvotech | Xgeva | Phase 1 | Comparative PK | Completed | Jul 2023 | Apr 2024 | Zvogra / Kefdensis / Xbonzy / Acvybra | NCT05876949 |
| AVT03 | Alvotech | Prolia | Phase 1 | Comparative PK | Completed | Jun 2022 | Oct 2023 | Zvogra / Kefdensis / Xbonzy / Acvybra | NCT05126784 |
| Arylia | AryoGen Pharmed | Prolia | Phase 3 | Comparative efficacy | Unknown, last active, not recruiting | Apr 2017 | Sep 2020 | no approval in the seven markets | NCT03293108 |
| CMAB807 | Biomabs | Prolia | Phase 3 | Comparative efficacy | Completed | Mar 2021 | Nov 2024 | no approval in the seven markets | NCT04591275 |
| ENZ215 | Enzene Biosciences | Prolia | Phase 1 | Comparative PK | Completed | Jan 2022 | May 2024 | Osqay / Enzene denosumab | NCT05245669 |
| ENZ215 | Enzene Biosciences | Prolia | Phase 3 | Comparative efficacy | Completed | Jul 2022 | Jul 2024 | Osqay / Enzene denosumab | NCT05405725 |
| FKS518 | Fresenius Kabi | Prolia | Phase 3 | Comparative efficacy | Completed | Jun 2021 | Aug 2023 | Conexxence / Bomyntra | NCT04934072 |
| RGB-14 | Gedeon Richter | Prolia | Phase 3 | Comparative efficacy | Completed | Sep 2021 | Oct 2023 | Enoby / Xtrenbo / Junod / Yaxwer | NCT05087030 |
| INTP23 | Intas Pharmaceuticals | Prolia | Phase 3 | Comparative efficacy | Unknown, last recruiting | Nov 2021 | Sep 2024 | Osvyrti / Jubereq | NCT05419427 |
| LY06006 | Luye | Prolia | Phase 3 | Comparative efficacy | Unknown, last active, not recruiting | Apr 2023 | Jul 2025 | no approval in the seven markets | NCT05853354 |
| LY06006 | Luye | Prolia | Phase 1 | Comparative PK | Completed | Mar 2021 | Mar 2023 | no approval in the seven markets | NCT06095427 |
| MW032 | Mabwell | Xgeva | Phase 1 | Comparative PK | Completed | Jun 2019 | Jan 2020 | no approval in the seven markets | NCT04798326 |
| SB16 | Samsung Bioepis | Prolia | Phase 3 | Comparative efficacy | Completed | Nov 2020 | Jun 2022 | Ospomyv / Xbryk / Obodence | NCT04664959 |
| SB16 | Samsung Bioepis | Prolia | Phase 1 | Comparative PK | Completed | Oct 2020 | Nov 2022 | Ospomyv / Xbryk / Obodence | NCT04621318 |
| GP2411 | Sandoz | Prolia | Phase 3 | Comparative efficacy | Completed | Jul 2019 | Apr 2022 | Jubbonti / Wyost | NCT03974100 |
| MB09 | mAbxience | Prolia | Phase 3 | Comparative efficacy | Completed | Mar 2022 | Dec 2023 | Boncresa / Oziltus / Denbrayce / Izamby | NCT05338086 |
| MB09 | mAbxience | Xgeva | Phase 1 | Comparative PK | Completed | Mar 2022 | Mar 2023 | Boncresa / Oziltus / Denbrayce / Izamby | NCT05299073 |
Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026. The full list across all molecules is on the pipeline page.
Questions
Why do denosumab biosimilars have two names?
The reference product is sold as Prolia for osteoporosis and Xgeva for cancer, and biosimilar makers do the same, so each product appears twice in the tables below.
Which was the first denosumab biosimilar?
Intas received the first permission in India in 2018. In the United States and Europe the first was Sandoz's Jubbonti and Wyost in 2024.
Are denosumab biosimilars interchangeable in the United States?
Yes, all of them. Most received the designation on the day they were approved or soon after.
Which denosumab biosimilars are available in the UAE?
Products from Accord and Sandoz so far. The rest are likely to follow, since they already hold European approval.
How are denosumab biosimilars tested?
Laboratory comparison, a study in healthy volunteers using a blood marker of bone turnover, and a year-long comparison of bone density in women with osteoporosis.
Do all denosumab biosimilars cover both uses?
Most do in the United States and Europe. In India some companies hold a permission for one presentation only. The tables show which.
Work with EvySaif on denosumab
Denosumab biosimilar landscape report
The register on this page as a delivered document: every approval, holder, presentation and pathway requirement across FDA, EMA, CDSCO and the Gulf, updated to the month, with the sources attached.
Request the landscape reportRegulatory gap assessment
For a developer deciding whether and where to file: a review of your analytical, PK and clinical package against what each regulator expects for denosumab, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S019EMA, applications for new human medicines under evaluation by the CHMP, August 2026 Primary (regulator)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)S009CDSCO and DBT, Guidelines on Similar Biologics 2016 Primary (regulator)S010CDSCO, Draft Guidelines on Similar Biologics 2025 Primary (regulator)S024ClinicalTrials.gov, study records (API v2, one query per molecule with the term biosimilar) Registry (sponsor-entered)
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