On 5 February 2026, Korea Biomedical Review reported that Korean headquartered HK inno.N has received approval from Korea’s Ministry of Food and Drug Safety for Izambia Prefilled Syringe and Denbrayce Injection, biosimilars to Amgen’s Prolia® and Xgeva® respectively.

HK inno.N entered an exclusive licence agreement with mAbxience in January 2023 for the commercialisation of the denosumab biosimilars.  mAbxience’s Izamby® and Denbrayce® received European approval in July 2025.

Celltrion’s Stoboclo® and Osenvelt® were the first denosumab biosimilars to be approved in Korea (November 2024).  In March 2025, Daewoong Pharmaceutical launched Celltrion’s Stoboclo® in Korea at a 28% discount to reference product Prolia®.  Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.  Boryung launched Samsung Bioepis’ Xbryk® on 1 August 2025, following its regulatory approval in May 2025.  Samsung Bioepis and Hanmi Pharmaceuticals announced their joint South Korean launch of Samsung Bioepis’ Obodence™ (reference: Prolia®) in July 2025.

On 5 February 2026, CVS Health announced that pharmacy benefits manager, CVS Caremark, will begin offering Samsung Bioepis’ Ospomyv® and Celltrion’s Stoboclo®, biosimilars to Amgen’s Prolia® (denosumab), on major US national commercial template formularies from 1 April 2026.

According to CVS, this is aimed at helping to expand the adoption of lower-cost biosimilar medications, and builds on its exclusion of AbbVie’s Humira® (adalimumab) from its formulary in favour of adalimumab biosimilars priced at a discount, including Sandoz’s Hyrimoz®.

Samsung Bioepis’ Ospomyv® was the second Prolia® biosimilar approved in the US (in February 2025).  BPCIA litigation commenced by Amgen alleging that Samsung Bioepis’ denosumab biosimilars infringed 36 US patents relating to denosumab was settled in September 2025.

Amgen and Celltrion settled their BPCIA litigation regarding denosumab in January 2025, with Celltrion launching Stoboclo® in July 2025 (following FDA approval in March 2025).  Celltrion’s second denosumab biosimilar, Osenvelt®, biosimilar to Amgen’s Xgeva®, was previously included on the CVS Caremark formulary.

On 19 January 2026, Hikma announced the US launch of Enoby™ and Xtrenbo™ (denosumab-gbde), biosimilars to Amgen’s Prolia® and Xgeva® respectively.

Enoby™ and Xtrenbo™ were approved by the FDA in September 2025.  The biosimilars were developed and are manufactured by Gedeon Richter.  Under a December 2021 licence and commercialisation agreement, Hikma is responsible for FDA registration and has exclusive rights to commercialise the biosimilars in the US.

In June 2025, Amgen commenced BPCIA litigation against Gedeon Richter and Hikma alleging infringement of 32 US patents relating to denosumab.  That litigation was settled in November 2025, with the terms of the settlement providing that Richter/Hikma’s denosumab biosimilars could not be launched in the US before at least 1 January 2026.

A number of denosumab biosimilars have been approved and launched in the US.  This includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), Accord’s Osvyrti® and Jubereq® (approved November 2025, not yet launched), and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).

On 9 January 2026, Boan Biotech announced that it has received regulatory approval from Bolivia’s National Agency of Medicines and Health Technologies (AGEMED) for BA6101, its 60 mg denosumab injection, biosimilar to Amgen’s Prolia®.  BA6101 is approved for the same indications as the reference product.

Boan Biotech’s denosumab biosimilars were approved in China in 2024 (Boluojia®; BA11021, referencing Amgen’s Xgeva®) and 2022 (Boyoubei®; BA6101, referencing Amgen’s Prolia®).  In November 2025, Boan Biologics’ MAAs for BA6101 and BA1102 were accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA).  According to Boan Biotech, regulatory submissions for its denosumab biosimilars are planned for Europe, the US and Japan, among other regions.

Denosumab biosimilars have been approved and launched around the world by a variety of sponsors.  In the US this includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, not yet launched), Accord’s Osvyrti® and Jubereq® (approved November 2025, not yet launched), and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).

On 1 January 2026, Medical Dialogues reported that Dr Reddy’s has disclosed to various stock exchanges that it has received a Complete Response Letter (CRL) from the FDA in relation to its Biologics Licence Application (BLA) for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

Dr Reddy’s and Alvotech entered into a licence and supply agreement in May 2024 for the commercialisation of AVT03, under which Alvotech develops and manufactures the product and Dr Reddy’s will commercialise it exclusively in the US, and semi-exclusively in the EU and UK.

The CRL follows a pre-licence inspection of Alvotech’s Reykjavik manufacturing facility.  The CRL did not identify any other deficiencies with the BLA.  Inspection of the same facility also resulted in a CRL issued in November 2025 for Alvotech’s BLA for AVT05, biosimilar to J&J’s Simponi® (golimumab).

Alvotech/Dr Reddy’s BLA for AVT03 was accepted for review by the FDA in March 2025.  In November 2025, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Dr Reddy’s/Alvotech alleging infringement of 31 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins like denosumab, and denosumab products.

AVT03 was approved in Europe in November 2025.  Alvotech has semi-exclusive commercialisation agreements for European markets with both STADA (June 2024)  and Dr Reddy’s (May 2024) in relation to AVT03.  STADA will market AVT03 as Kefdensis® (referencing Prolia®) and Zvogra® (referencing Xgeva®), while Dr. Reddy’s will market AVT03 as Acvybra® (referencing Prolia®) and Xbonzy® (referencing Xgeva®).

On 22 December 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has approved Boncresa™ and Oziltus™ (MB09), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively.  The approval follows the FDA’s March 2025 acceptance for review of Amneal/mAbxience’s BLA for the denosumab biosimilars.

Under a partnership announced in October 2023, mAbxience is responsible for developing and manufacturing the denosumab biosimilars, while Amneal is pursuing regulatory approval and holds the exclusive US commercialisation rights.

Amneal/mAbxience’s denosumab biosimilars are currently the subject of US BPCIA litigation commenced by Amgen on 6 November 2025.  Amgen is asserting infringement of 31 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins like denosumab, and denosumab products.

Other denosumab biosimilars approved in the US include Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, not yet launched) and Accord’s Osvyrti® and Jubereq® (approved November 2025, not yet launched).

On 18 December 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) November 2025 meeting were published, including recommendations for the listing of three Celltrion biosimilars on the Pharmaceutical Benefits Scheme (PBS):

• Eydezenlt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg);
• Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab); and
• Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab).

Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV).  It was followed by Sandoz’s Afqlir® and Enzeevu® on 27 May 2025, and Samsung Bioepis’ Opuviz® on 18 September 2025, which were each approved for all reference indications.  Sandoz’s products were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme, though have not yet been listed.

In December 2025, Regeneron/Bayer and Sandoz settled all Australian aflibercept patent infringement/revocation proceedings, with the terms of the settlement not otherwise being disclosed.  Regeneron/Bayer are defending pending revocation proceedings commenced by Actor Pharmaceuticals in August 2025 and have cross-claimed for infringement.

In addition to Celltrion’s Stoboclo® and Osenvelt® (approved April 2025), there are three other sponsors with denosumab biosimilars approved in Australia:  Sandoz’s Jubbonti® and Wyost® (August 2024), Samsung Bioepis’ Ospomyv® and Xborso® (July 2025) and Accord’s Denolia™/Deskeltia™ and Dostiva™/Dexeva™ (October 2025).  On 1 August 2025, Sandoz’s Jubbonti® and Wyost® became the first biosimilars to Amgen’s Prolia® and Xgeva® to be PBS-listed.  In April 2025, Amgen commenced Court proceedings in Australia seeking preliminary discovery of documents from Sandoz in relation to its denosumab biosimilars.  That proceeding concluded and Amgen commenced patent infringement litigation against Sandoz in the Federal Court of Australia in June 2025.

Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and to be considered (and now recommended) for PBS-listing.

On 16 December 2025, China-based Mabwell announced that it has completed its first commercial shipment of its denosumab biosimilars outside China, although the destination(s) of the shipment is not disclosed in the press release.

Mabwell’s biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) are marketed in China as Mailishu® (approved March 2023 for treatment of osteoporosis in postmenopausal women at high risk of fracture) and Maiweijian™ (approved April 2024 for the treatment of giant cell tumour of the bone), respectively.

The first overseas shipment by Mabwell of the biosimilars comes shortly after Mabwell’s denosumab biosimilar licensee in Pakistan, Searle (under a July 2023 licence agreement), gained approval from Pakistan’s Drug Regulatory Authority to market and sell denosumab biosimilars in that country (announced 1 September 2025).

According to Mabwell, it has submitted marketing authorisation applications for its denosumab biosimilars in several other key markets, including Jordan, Egypt, and Brazil.

On 10 December 2025, Zydus Lifesciences announced the Indian launch of Zyrifa™ (denosumab 120mg SC), biosimilar to Amgen’s Xgeva® (denosumab).

The launch of Zydus’ denosumab biosimilar in India follows a flurry of European denosumab biosimilar launches on 1-2 December, including Sandoz’s Jubbonti® and Wyost®, Fresenius Kabi’s Conexxence® and Bomyntra®, Zentiva’s Zadenvi®, Accord Healtcare’s Osvyrti® and Jubereq® and Samsung Bioepis’ Xbryk™ (available from December 2025).

Denosumab biosimilars launched in the US include Sandoz’s Jubbonti® and Wyost® (June 2025), Celltrion’s Stoboclo® and Osenvelt® (July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025), and Biocon’s Bosaya™ and Aukelso™ (October 2025).

In August 2025, it was reported that India’s Central Drugs Control Organisation (CDSCO) had reviewed and accepted without objection a final Clinical Study Report submitted by Intas Pharmaceuticals for its proposed denosumab biosimilar.

On 24 November 2025, Alvotech announced that the European Commission has approved denosumab biosimilar, AVT03, in two presentations referencing Amgen’s Prolia® and Xgeva®.

Alvotech has semi-exclusive commercialisation agreements for European markets with both STADA (June 2024)  and Dr Reddy’s (May 2024) in relation to AVT03.  STADA will market AVT03 as Kefdensis® (referencing Prolia®) and Zvogra® (referencing Xgeva®), while Dr. Reddy’s will market AVT03 as Acvybra® (referencing Prolia®) and Xbonzy® (referencing Xgeva®).

The next day, on 25 November 2025, Teva Pharmaceuticals announced that it also received European Commission approval for its two denosumab biosimilars, Ponlimsi® (referencing Prolia) and Degevma® (referencing Xgeva®).

The flurry of approvals follow the positive opinions adopted by the EMA’s CHMP in September 2025 for STADA’s, Dr Reddy’s and Teva’s denosumab products.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in Europe (May 2024), and on 1 December 2025, became the first to launch.  There are a number of other denosumab biosimilars already approved in Europe although none have launched to date: Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Accord Healthcare’s Jubereq® and Osvyrti® (May 2025); Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025) and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025).