On 7 March 2025, the US District Court for the District of New Jersey ordered the dismissal of all claims and counterclaims in Amgen’s BPCIA patent infringement proceeding against Fresenius Kabi in relation to its denosumab biosimilar.  The order followed a stipulation by the parties as to their settlement of the litigation, which was filed with the Court on 4 March 2025.

Neither Amgen nor Fresenius Kabi have issued press releases about the settlement as at the date of this report and the terms on which the proceeding was settled, including the US launch date for Fresenius’ denosumab biosimilars, are currently unknown.

Amgen originally commenced proceedings against Fresenius Kabi on 4 October 2024 in the US District Court for the Northern District of Illinois (Eastern Division) alleging infringement of 33 US patents relating to denosumab.  The litigation followed Fresenius’ submission of an abbreviated Biologics Licence Application (aBLA) to the US FDA seeking approval to manufacture and sell its FKS518, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).  Fresenius’ aBLA for denosumab was accepted for review by the FDA on 27 May 2024.

In the context of the litigation, Amgen issued a subpoena to Cytiva subsidiary media supplier HyClone Laboratories requesting information including the full formulation of HyClone’s off-the-shelf cell culture supplement, HyClone™ Cell Boost™ 7a (CB7A).  Amgen has now withdrawn that subpoena given the settlement of the underlying litigation with Fresenius.

The BPCIA proceeding against Fresenius was one of five that Amgen had commenced in the US in relation to denosumab biosimilars, which were centralised in the US District Court for the District of New Jersey in February 2025.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances).  Amgen also settled its US litigation against Celltrion in January 2025, permitting launch of Celltrion’s yet to be US-approved denosumab biosimilar from 1 June 2025.  The remaining court proceedings, against Samsung Bioepis (Ospomyv™/Xbryk™/SB16 approved February 2025, litigation commenced August 2024) and Accord/Intas (INTP23, litigation commenced November 2024), remain pending.

On 3 March 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has accepted for review their aBLA for two new denosumab biosimilars referencing Amgen’s Prolia® and Xgeva®.   The FDA has assigned a target action date in Q4 2025.

The biosimilars are being co-developed, with mAbxience responsible for the development and manufacturing and Amneal pursuing regulatory approval and having exclusive US commercialisation rights.  The two companies also collaborate on Alymsys®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), which  was approved in the US in April 2022.

There are three denosumab biosimilars approved in the US: Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).

There are also a number of denosumab biosimilars in the wings, with the FDA having accepted applications for review, including for: Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024).  Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

On 3 March 2025, Celltrion announced that it has received US FDA approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the same indications as the reference medicines.  The approval follows European approval of Celltrion’s denosumab biosimilars in February 2025.

Stoboclo® and Osenvelt® are the third denosumab biosimilars to be approved in the US, trailing Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024).

Celltrion filed its aBLA for CT-P41 in the US in December 2023.  However, 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 was settled in January 2025, allowing Celltrion to launch its denosumab biosimilars in the US from 1 June 2025.

On 19 February 2025, Celltrion announced that the European Commission has approved Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the same indications as the reference medicines.

Celltrion’s denosumab biosimilars are the third to be approved in Europe, following approval of Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).

Stoboclo® and Osenvelt® received positive opinions from the EMA’s CHMP in December 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).

Celltrion filed an abbreviated Biologics Licence Application for CT-P41 in the US in December 2023.  However, 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 was settled in January 2025, allowing Celltrion to launch its denosumab biosimilars in the US from 1 June 2025.

On 16 February 2025, Samsung Bioepis announced that the European Commission has approved Obodence™ (60mg pre-filled syringe) and Xbryk™ (120mg vial), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.  The biosimilars are approved for the same indications as the reference medicines.

This announcement came just days after the FDA approval of Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb) on 13 February 2025.

Obodence™ and Xbryk™ received positive CHMP opinions in November 2024, and are the second set of denosumab biosimilars to be approved in the EU, following Sandoz’s Wyost® and Jubbonti® (approved May 2024).

The European Medicines Agency 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).  The CHMP adopted positive opinions for Celltrion’s Osenvelt®/CT-P41 and Stoboclo®/CT-P41 in December 2024.

On 13 February 2025, the US FDA approved Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb, SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively.  The biosimilars are approved for the same indications as the reference medicines.

Ospomyv™ and Xbryk™ are the second denosumab biosimilars to be approved in the US, following the approval of Sandoz’s Wyost® and Jubbonti® in March 2024.

There are also a number of denosumab biosimilars in the wings, with the FDA having accepted applications for review, including for: Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024).  In December 2023, Celltrion filed an abbreviated Biologics Licence Application (aBLA) for its denosumab biosimilar, CT-P41.  Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).

In August 2024, Amgen commenced US BPCIA patent infringement proceedings against Samsung Bioepis in relation to its denosumab biosimilars.  That litigation remains pending, as do similar proceedings brought by Amgen against Fresenius Kabi (FKS518/commenced October 2024) and Accord/Intas (INTP23/commenced November 2024).  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances).  Amgen also settled its US litigation against Celltrion in January 2025, permitting launch of Celltrion’s yet to be US-approved denosumab biosimilar from 1 June 2025.

Samsung Bioepis received a positive opinion from the European Medicine Agency’s CHMP in November 2024 for its denosumab biosimilars (to be marketed as Obodence™ and Xbryk™ in Europe).

On 10 February 2025, Pfizer and Astellas Pharma announced positive results from their Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39).  The trial evaluated the efficacy and safety of Padcev® (enfortumab vedotin-ejfv) in combination with MSD’s Keytruda® (pembrolizumab) in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).  The results demonstrated a sustained overall survival and progression-free survival benefit consistent with the findings of the primary analysis after an additional 12 months of follow-up.

The combination therapy was approved in China in January 2025 for adult patients with locally advanced or metastatic urothelial cancer.  It has received several other approvals over the past 12 months, including in the UK (October 2024) the EU (September 2024), Japan (September 2024), Canada (August 2024), and the US (December 2023).

On 6 February 2025, the US Judicial Panel on Multijurisdictional Litigation granted Amgen’s request to centralise its BPCIA litigation alleging that each of Samsung Bioepis, Fresenius Kabi and Accord Biopharma are infringing US patents covering Amgen’s Prolia® and Xgeva® (denosumab).  The Panel ruled that each of the lawsuits involve “common issues of fact and law” and should be transferred to the US District Court for the District of New Jersey.  This was because Amgen had previously commenced three denosumab actions in that jurisdiction and the New Jersey Judge hearing the matters was familiar with the issues.

Amgen commenced the proceedings against Samsung Bioepis in August 2024 (District of New Jersey), Fresenius Kabi in October 2024 (Northern District of Illinois) and Accord Biopharma in November 2024 (Eastern District of North Carolina) in respect of Biologics Licence Applications filed for denosumab biosimilars SB16, FKS518 and INTP23, respectively.

A dispute with Sandoz, commenced by Amgen in May 2023 in the US District Court for the District of New Jersey, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, from 31 May 2025 (or earlier in certain undisclosed circumstances).  On 24 January 2025, Amgen announced that it had settled its patent infringement litigation against Celltrion in the US District Court for the District of New Jersey, relating to Celltrion’s biosimilar denosumab CT-P41.  An injunction, granted by consent, preventing Celltrion from launching CT-P41 in the US expires on 1 June 2025, permitting US launch of Celltrion’s denosumab biosimilars from that date.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024.  No other denosumab biosimilars have been approved in the US to date, although a number of applicants have had applications accepted for review by the FDA, including: Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024).

On 4 February 2025, Cytiva subsidiary media supplier HyClone Laboratories filed a motion in the US District Court for the District of Utah, seeking to quash a subpoena issued to it by Amgen in the context of denosumab BPCIA patent infringement litigation Amgen commenced against Fresenius Kabi in October 2024.  Cytiva’s HyClone is not a party to the BPCIA litigation, which relates to Fresenius’ FKS518, biosimilar to Amgen’s Xgeva® and Prolia® (denosumab).

Amgen’s subpoena requests HyClone Laboratories to provide information that includes the full formulation of its off-the-shelf cell culture supplement, HyClone™ Cell Boost™ 7a (CB7A).  Amgen alleges that Fresenius’ process for producing FKS518 uses CB7A and that the resulting cell culture medium infringes claims of Amgen’s patents (eg. US 10,167,492).

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.

The litigation against Fresenius is one of five US proceedings commenced by Amgen in relation to denosumab biosimilars.  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 (or earlier in certain undisclosed circumstances).  Amgen also settled its litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025.  The remaining court proceedings, against Fresenius, Samsung Bioepis (SB16/commenced August 2024) and Accord/Intas (INTP23/commenced November 2024), remain pending.

On 24 January 2025, Amgen announced that it has settled its patent infringement litigation against Celltrion in the US District Court for the State of New Jersey, relating to Celltrion’s biosimilar denosumab.

Amgen had commenced proceedings against Celltrion in May 2024, alleging infringement of 29 patents relating to denosumab.  The allegations followed Celltrion’s abbreviated Biologics Licence Application (aBLA) submitted in December 2023 for CT-P41, its biosimilar to Amgen’s Xgeva® and Prolia® (denosumab).

Pursuant to the settlement agreement, the parties consented to the Court making an order that the asserted claims of the 29 patents in suit are valid, enforceable and infringed by the exploitation of Celltrion’s biosimilar products in the US.  The Court further granted an injunction, by consent, preventing it from making or selling its biosimilar denosumab in the US, except as permitted by the confidential settlement agreement.

The injunction expires on 1 June 2025, permitting Celltrion to launch its denosumab products in the US from that date.

The proceeding against Celltrion was one of five that Amgen had commenced in the US in relation to denosumab biosimilars.  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 (or earlier in certain undisclosed circumstances).  The remaining court proceedings, against Fresenius Kabi (FKS518/commenced October 2024), Samsung Bioepis (SB16/commenced August 2024) and Accord/Intas (INTP23/commenced November 2024), remain pending.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024.  No other denosumab biosimilars have been approved in the US to date, although Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024) have each had Biologics Licence Applications accepted for review by the FDA.

Celltrion’s Osenvelt®/CT-P41, biosimilar to Amgen’s Xgeva®, and Stoboclo®/CT-P41, biosimilar to Amgen’s Prolia®, received positive opinions from the EMA’s CHMP in December 2024.