At its November 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two biosimilars:

• Enzene/Theramex’s Osqay®, biosimilar to Amgen’s Prolia® (denosumab). Enzene and Theramex entered into an agreement in 2021 under which Enzene will supply Theramex with its denosumab biosimilar for commercialisation in Europe, the UK, Switzerland and Australia; and
• Gan & Lee Pharmaceuticals’ Ondibta®, biosimilar to Sanofi’s Lantus® (insulin glargine).

There are a number of denosumab biosimilars already approved in Europe although none have launched to date: Sandoz’s Wyost® and Jubbonti® (May 2024), 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).

The EMA’s CHMP adopted positive opinions in September 2025 for STADA/Alvotech’s Kefdensis® and Zvogra® (AVT03, MAA accepted October 2024), Dr Reddy’s Acvybra® and Xbonzy®, Teva’s Ponlimsi™ and Degevma™ (TVB-009P, MAA accepted October 2024), and Intas’ Denosumab Intas.

Insulin glargine biosimilars have been approved in Europe since 2014 (the first was Eli Lilly’s Abasaglar®).

On 12 November 2025, Shanghai Henlius announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorisation applications (MAAs) for two denosumab injections: 60mg (Bildyos®; biosimilar to Amgen’s Prolia®) and 120mg (Bilprevda®; biosimilar to Amgen’s Xgeva®).

Just five days earlier, Boan Biotech announced that its MAAs for denosumab biosimilars, BA6101 (60mg, referencing Prolia®) and BA1102 (120mg, referencing Xgeva®), were also accepted by the MHRA.

There are a number of denosumab biosimilars approved in the UK, including: Sandoz’s Wyost® and Jubbonti® (November 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (March 2025), Celltrion’s Stoboclo® and Osenvelt® (May 2025), Accord’s Osvyrti® (June 2025) and Biocon’s Evfraxy® and Vevzuo® (July 2025).

The EMA’s CHMP adopted positive opinions in September 2025 for STADA/Alvotech’s Kefdensis® and Zvogra® (AVT03, MAA accepted October 2024), Dr Reddy’s Acvybra® and Xbonzy®, Teva’s Ponlimsi™ and Degevma™ (TVB-009P, MAA accepted October 2024), and Intas’ Denosumab Intas.

On 7 November 2025, Boan Biologics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorisation applications (MAAs) for two denosumab injections: 60mg (BA6101; biosimilar to Amgen’s Prolia®) and 120mg (BA1102; biosimilar to Amgen’s Xgeva®).

There are five sponsors with denosumab biosimilars approved in the UK, including: Sandoz’s Wyost® and Jubbonti® (November 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (March 2025), Celltrion’s Stoboclo® and Osenvelt® (May 2025), Accord’s Osvyrti® (June 2025) and Biocon’s Evfraxy® and Vevzuo® (July 2025).

Boan Biotech’s denosumab biosimilars have previously been approved in China in 2024 (Boluojia®; BA11021) and 2022 (Boyoubei®; BA6101).

On 6 November 2025, Amgen filed two separate BPCIA litigation suits in the US District Court for the District of New Jersey, against each of Dr Reddy’s/Alvotech and Amneal/mAbxience, asserting infringement of 31 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins like denosumab, and denosumab products.

The litigation follows the FDA’s March 2025 acceptance for review of both Alvotech/Dr Reddy’s Biologics Licence Application (BLA) for AVT03 and Amneal/mAbxience’s BLA for its denosumab biosimilars (MB09).

Under a partnership announced in October 2023, Amneal/mAbxience’s denosumab biosimilars are being developed and manufactured by mAbxience, with Amneal pursuing regulatory approval and having exclusive US commercialisation rights.  In May 2024, Dr Reddy’s and Alvotech entered into a licence and supply agreement 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 filing of the two new complaints means Amgen currently has four US proceedings pending regarding denosumab biosimilars, including lawsuits against Hikma/Gedeon Richter and Shanghai Henlius/Organon, commenced on 25 June 2025.  Amgen has settled a further six US proceedings relating to denosumab biosimilars with:

• Sandoz: proceedings commenced in May 2023, were resolved in April 2024, with Sandoz launching its denosumab biosimilars, Jubbonti® and Wyost®, in June 2025;
• Fresenius Kabi: proceedings commenced in October 2024 were resolved by a global settlement, resulting in the launch of Fresenius’ Conexxence® and Bomyntra® in early July 2025;
• Celltrion: US proceedings settled in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025;
• Accord and Intas: US litigation with Amgen settled in July 2025, permitting launch of Accord/Intas’ denosumab biosimilar from 1 October 2025;
• Samsung Bioepis settled in early September 2025, with the terms of that settlement, including launch dates for Samsung Bioepis’ denosumab biosimilars, remaining confidential; and
• Biocon: US proceedings commenced on 30 June 2025 were settled shortly thereafter, permitting Biocon’s 1 October 2025 launch of Bosaya™ and Aukelso™.

On 31 October 2025, Accord’s denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®, were approved by Australia’s Therapeutic Goods Administration (TGA) as follows:

• DENOLIA (450306) and DESKELTIA (450307) – denosumab 60mg/1mL solution for injection prefilled syringe with automatic needle guard;
• DOSTIVA (450305) and DEXEVA (450308) – denosumab 70mg/mL (120mg/1.7mL) solution for injection vial.

Accord is the fourth sponsor to obtain approval of denosumab biosimilars in Australia, following Sandoz’s Jubbonti® and Wyost® (August 2024), Celltrion’s Stoboclo® and Osenvelt® (April 2025), and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).

On 1 August 2025, Sandoz’s Jubbonti® and Wyost® became the first biosimilars to Amgen’s Prolia® and Xgeva® to be PBS-listed.  At its November 2025 meeting, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, for PBS-listing for all reference indications.

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.

On 30 October 2025, New Zealand’s Medsafe approved Celltrion’s Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva (denosumab), respectively.  This makes Celltrion’s Stoboclo® and Osenvelt® the second pair of denosumab biosimilars approved in New Zealand, following Sandoz’s Jubbonti® and Wyost® in May 2025.

Celltrion’s denosumab biosimilars have been approved in various regions, including Korea (approved November 2024, launched March 2025), Europe (approved February 2025, not yet launched), the US (approved March 2025, launched July 2025), Australia (approved April 2025, not yet launched) and Canada (approved September 2025, not yet launched).

In May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab.  That litigation settled in January 2025, permitting the US launch of Celltrion’s denosumab biosimilars in July 2025.

On 29 October 2025, GlycoNex announced that the last patient has received the final dose in its phase 3 clinical study of SPD8, biosimilar to Amgen’s Prolia®/Xgeva® (denosumab).  The trial, which was commenced in late 2024, is assessing the efficacy, safety and immunogenicity of SPD8 in patients with osteoporosis.  GlycoNex plans to report top-line results from the study in the second quarter of 2026.

SPD8 was developed by GlycoNex in collaboration with Mitsubishi Gas Chemical.  In December 2024, GlycoNex entered into a licensing agreement with an undisclosed partner for SPD8, under which the licensee will be responsible for developing SPD8, securing regulatory approval, and commercialising the biosimilar in an undisclosed market.

Denosumab biosimilars have been approved around the world, including seven pairs of denosumab biosimilars approved in the US: 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) and Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, not yet launched).

The FDA has approved denosumab biosimilars Conexxence® and Bomyntra® (Fresenius Kabi) and Stoboclo® and Osenvelt® (Celltrion) as interchangeable with Amgen’s Prolia® and Xgeva®, respectively, for all approved indications, effective as of 29 October 2025.

Fresenius Kabi launched Conexxence® and Bomyntra® in early July 2025, following a global settlement agreement with Amgen, resulting in the dismissal of US BPCIA litigation commenced by Amgen in October 2024.  Amgen and Celltrion also settled their BPCIA litigation in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025.

There are seven pairs of denosumab biosimilars approved in the US: 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), and Richter/Hikma’s Enoby™and Xtrenbo™ (approved September 2025, not yet launched).

On 1 October 2025, Biocon announced that it has entered into a settlement and licence agreement with Amgen that resolves pending BPCIA patent litigation and permits Biocon’s 1 October 2025 US launch of Bosaya™ and Aukelso™ (denosumab-kyqq), biosimilars to Amgen’s Prolia® and Xgeva® respectively.

Amgen had filed the BPCIA litigation against Biocon on 30 June 2025 in the US District Court for the District of Massachusetts, Eastern Division, asserting infringement of 34 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products.

The proceeding against Biocon was one of a number of proceedings that Amgen commenced in the US in relation to denosumab biosimilars, six of which have now settled (including the Biocon settlement):

• A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, with Sandoz launching its denosumab biosimilars, Jubbonti® and Wyost®, in June 2025.
• Fresenius Kabi launched Conexxence® and Bomyntra® in early July 2025, following a global settlement agreement with Amgen, resulting in the dismissal of US BPCIA litigation commenced by Amgen in October 2024.
• Celltrion settled in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025.
• Accord and Intas settled US litigation with Amgen in July 2025, permitting launch of Accord/Intas’ denosumab biosimilar from 1 October 2025.
• Samsung Bioepis settled in early September 2025, with the terms of that settlement, including launch dates for Samsung Bioepis’ denosumab biosimilars, remaining confidential.

Amgen still has pending US denosumab litigation against Hikma/Gedeon Richter and Shanghai Henlius/Organon, which have had denosumab biosimilar applications accepted for review by the FDA.

Bosaya™ and Aukelso™ received FDA approval in September 2025 and were granted provisional interchangeability designation for all approved indications.  They were the sixth pair of denosumab biosimilars to be approved in the US, following 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), and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched).  Richter/Hikma’s Enoby™ and Xtrenbo™ (denosumab qbde) were subsequently approved later in September 2025.

On 29 September 2025, Fresenius Kabi announced that the US Centers for Medicare and Medicaid Services (CMS) assigned a permanent billing code for Conexxence® and Bomyntra®, biosimilars to Regeneron/Bayer’s Prolia® and Xgeva® (denosumab), respectively.  This will provide a streamlined reimbursement procedure for the products, effective 1 October 2025.

Conexxence® and Bomyntra® were FDA approved in March 2025 and launched in the US on 1 July 2025.

Fresenius Kabi entered a global settlement with Amgen in respect of its denosumab biosimilars in March 2025.  The settlement resulted in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen against Fresenius in October 2024.  The global settlement permits European launch of Fresenius’ biosimilars at the end of November 2025.  Conexxence® and Bomyntra® were approved in Europe in July 2025.