On 2 June 2025, Sandoz announced its US launch of Wyost® and Jubbonti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), respectively.  Wyost® and Jubbonti® are the first and only interchangeable denosumab biosimilars to be approved (in March 2024), and launched, in the US and have the same indications, dosage forms and routes of administration as Amgen’s denosumab products.

The US launch of Sandoz’s denosumab biosimilars follows a settlement agreement entered into by Sandoz and Amgen in April 2024 resolving US patent infringement litigation commenced by Amgen in May 2023 and permitting US launch of Wyost® and Jubbonti® from 31 May 2025.

Wyost® and Jubbonti® are approved in Europe (May 2024) and Australia (August 2024) and, in December 2024, they were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).

There are currently three other sponsors with denosumab biosimilars approved in the US: Fresenius Kabi’s Conexxence® and Bomyntra® (March 2025), Celltrion’s Stoboclo® and Osenvelt® (March 2025) and Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025).  Amgen settled patent litigation against Celltrion regarding denosumab biosimilars in January 2025, permitting US launch of Celltrion’s denosumab biosimilars from 1 June 2025 (Celltrion’s denosumab biosimilars have not yet been launched in the US at the date of this report).  In March 2025, Amgen entered into a global settlement of its patent infringement litigation with Fresenius Kabi, allowing US launch of Fresenius’ denosumab biosimilars in mid-2025 (the precise date is unknown).  BPCIA litigation commenced by Amgen against Samsung Bioepis and Accord/Intas regarding their denosumab biosimilars remains pending.

On 30 May 2025, Samsung Bioepis announced that it has received marketing approval in South Korea for its second denosumab biosimilar, Xbryk™, biosimilar to Amgen’s Xgeva® (denosumab).  This follows the South Korean approval of Samsung Bioepis’ Obodence™ (biosimilar to Amgen’s Prolia®) in April 2025.

Samsung Bioepis’ denosumab biosimilars were approved in February 2025 in both the US (marketed as Ospomyv™/Xbryk™) and Europe (marketed as Obodence™/Xbryk™).  In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars.  Those proceedings are ongoing.

Three months after Cytiva subsidiary media supplier HyClone Laboratories filed a motion to quash a subpoena issued to it by Amgen in the context of denosumab BPCIA litigation between Amgen and Fresenius Kabi (subsequently settled), HyClone has filed a similar motion to quash an Amgen subpoena issued in the context of BPCIA patent infringement litigation commenced by Amgen against Accord and Intas.  The motion was filed by HyClone on 14 May 2025 in the US District Court for the District of Utah.  On 28 May 2025, Amgen filed a motion seeking to have the dispute regarding the subpoena transferred to the District of New Jersey.

HyClone is not a party to the underlying BPCIA litigation, which relates to Accord/Intas’ INTP23, biosimilar to Amgen’s Xgeva® and Prolia® (denosumab).  Amgen commenced the BPCIA proceedings against Accord/Intas in November 2024.  The proceedings were then centralised in February 2025 in the US District Court for the District of New Jersey with similar BPCIA proceedings Amgen brought against Samsung Bioepis (August 2024) and Fresenius Kabi (October 2024).

Amgen’s subpoena to HyClone requests 32 categories of information, including the full formulations of HyClone’s cell culture media supplements, marketed as HyClone™ Cell Boost™ 7a Supplement and HyClone™ Cell Boost™ 7b Supplement.  Amgen alleges that this information is necessary because Accord/Intas infringe certain of its patents (eg. US 7,928,205, US 10,513,723 and US 11,254,963) based on concentrations and ingredients in the cell culture media used by Accord to manufacture its denosumab biosimilar.

HyClone argues that the subpoena should be quashed for a number of reasons, including that the information sought is irrelevant and the request is overly burdensome because it would require the disclosure of trade secrets.

Amgen has settled three of its US denosumab disputes over the last 12 months.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, from 31 May 2025.  Amgen settled its litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025.  In March 2025, Amgen entered into a global settlement of its patent infringement litigation in relation to Fresenius Kabi’s denosumab biosimilar, allowing US launch of Fresenius’ biosimilar in mid-2025.  Amgen’s BPCIA litigation against Accord/Intas and Samsung Bioepis regarding their denosumab biosimilars remains pending.

At its May 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three denosumab biosimilars: Sandoz’s Rolcya®, biosimilar to Amgen’s Prolia®, and Fresenius Kabi’s Conexxence® and Bomyntra®, biosimilars to Amgen’s Prolia® and Xgeva® respectively.

Rolcya® is a second Prolia® biosimilar for Sandoz, which was the first sponsor to obtain approval of denosumab biosimilars in Europe in May 2024 with Wyost® and Jubbonti®.  Sandoz has previously reported that it expects to launch Wyost® and Jubbonti® in Europe from November 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 “later in H2 of 2025” and launch in the US in “mid-2025”.

In addition to Sandoz’s Wyost® and Jubbonti®, there have been two other sponsors with denosumab biosimilars approved in Europe to date:  Celltrion’s Stoboclo®/Osenvelt® (February 2025) and Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025).  CHMP positive opinions were adopted in March 2025 for Accord Healtcare’s Jubereq®/Osvyrti® and in April 2025 for Gedeon Richter’s Junod®/Yaxwer® (April 2025), Biocon’s Vevzuo®/Denosumab BBL (brand name currently under approval), mAbxience’s Izamby®/Denbrayce® and Zentiva’s Zadenvi®/Enwylma®.

On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for eight denosumab biosimilars.

Gedeon Richter’s Junod® and Yaxwer®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, received positive opinions for all indications of the reference medicines.  The EMA had accepted Richter’s MAA for review in July 2024.  Gedeon Richter’s denosumab biosimilars are the first monoclonal antibodies in the company’s biosimilar portfolio.

Biocon Biologics’ Vevzuo® (reference: Xgeva®) and Denosumab BBL (brand name currently under approval) (reference: Prolia®) were also recommended by CHMP.  The European sponsor for the products is Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics.

Positive recommendations were also given to mAbxience’s Izamby® and Zentiva’s Zadenvi®, both biosimilars to Prolia®.

To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).  Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

On 15 April 2025, Petrovax Pharm announced that it is launching its denosumab biosimilar (Forsedeno®) in the Russian market after the Russian Ministry of Health granted marketing authorisation.  This marks Russia’s first approved denosumab biosimilar to Amgen’s Prolia/Xgeva.

Petrovax Pharm acquired the rights to the denosumab biosimilar in Russia under an agreement with AryoGen Pharmed (part of CinnaGen Group).

In August 2024 Bio-Thera and Pharmapark entered a licence and supply agreement for a secukinumab biosimilar in Russia.

On 10 April 2025, Aurobindo subsidiary, CuraTeQ Biologics, reported its successful Phase I results for BP16, biosimilar to Amgen’s Prolia® (denosumab).

The Phase I study, which included 204 subjects from Australia and New Zealand, showed that BP16 demonstrated comparable safety, pharmacodynamics and immunogenicity profiles to both the European and US versions of Prolia®; successfully meeting all the predefined endpoints.

CuraTeq anticipates completion of its Phase 3 study in women with postmenopausal osteoporosis by May/June 2025.

To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).  The EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

There are four sponsors with denosumab biosimilars approved in the US: Fresenius Kabi’s Conexxence® and Bomyntra® (March 2025), Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).  A number of denosumab biosimilar BLAs are currently under review by the FDA, including for: Alvotech/Dr Reddy’s (March 2025), Amneal/mAbxience (March 2025), Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), and Teva (October 2024).  Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

On 6 April 2025, ChosunBiz reported that Samsung Bioepis has received approval in South Korea for Obodence™, biosimilar to Amgen’s Prolia® (denosumab).

Obodence™ is Samsung Bioepis’ 10th biosimilar to be approved in South Korea, including following Epyztek® (ustekinumab) in April 2024, Afilivu® (aflibercept) in February 2024, and Episcli® (eculizumab) in January 2024.

Samsung Bioepis’ denosumab biosimilars were approved in February 2025 in both the US (marketed as Ospomyv™/Xbryk™) and Europe (marketed as Obodence™/Xbryk™).  In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars.  Those proceedings are ongoing.

On 4 April 2025, Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, were approved by Australia’s Therapeutic Goods Administration (TGA).  Celltrion is the second sponsor to achieve approval of its denosumab biosimilars in Australia, following approval of Sandoz’s Jubbonti® and Wyost® in August 2024.

In December 2024, Sandoz’s denosumab biosimilars were recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS).  In November 2024, Amgen secured approvals for 5 new denosumab brands, suggesting that Amgen intends to cannibalise its own denosumab market in Australia.

In May 2024, Amgen licensed generics giant Arrotex to supply Prolia® in Australia.

At its March 2025 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biosimilars.

Accord Healthcare’s Jubereq® and Osvyrti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab) respectively, have received recommendations for the same indications as the reference products.

In addition, the CHMP has recommended Celltrion’s Qoyvolma®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab) for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies.

To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).  The EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

There are a number of ustekinumab biosimilars being marketed in the EU, with three launched during 2024, STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024.  Previously approved ustekinumab biosimilars in Europe include Biocon’s Yesintek® (February 2025), Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024).