Denosumab's US biosimilars entered in stages on settlement-permitted dates, from June 2025 to January 2026

Reports of the Amgen settlements give permitted entry dates from 31 May 2025 to 1 January 2026, while Amgen's own filing puts a key US patent expiry in February 2025. Amgen's global Prolia sales were $1.05bn to $1.14bn a quarter through 2025, then $0.73bn to $0.76bn a quarter in the first half of 2026. Its US Prolia sales fell from $0.81bn in the third quarter of 2025 to $0.48bn in the second quarter of 2026.

Where do US denosumab biosimilars stand?

12 / 10 Approved biosimilar applications and the sponsors that hold them, on the FDA register. The first approval was 5 March 2024 and the latest 25 September 2026. Source: FDA Drugs@FDA via openFDA, retrieved 23 October 2026

31 May 2025 Earliest US launch the Sandoz settlement is reported to permit. Celltrion's is reported as 1 June 2025, Accord's and Biocon's as 1 October 2025 (Accord's FDA approval followed on 29 October 2025), and Hikma's as not before 1 January 2026. Source: Pearce IP, 2 June 2025, 8 July 2025, 1 October 2025 and 19 January 2026; Venable's BiologicsHQ report of the July 2025 Accord consent judgment, a court order recording the agreed terms (secondary; settlement terms are confidential)

5 launches US launches announced in the sources read: Sandoz on 2 June 2025, Fresenius Kabi on 1 July 2025, Celltrion on 7 or 8 July 2025, Biocon on 1 October 2025 and Hikma on 19 January 2026. Source: Sandoz and Fresenius releases (company); Pearce IP and Center for Biosimilars (secondary)

Feb 2025 Amgen's Form 10-K says its patents for RANKL antibodies (denosumab binds the protein RANKL) for Prolia and Xgeva "expired in February 2025 in the United States". Amgen's complaints asserted 29 patents against Celltrion, 34 against Biocon and 35 against Alkem in the reports read. Source: Amgen Form 10-K for 2025; Pearce IP and Goodwin (secondary)

$2,221m to $1,486m Global Prolia sales, first half of 2025 against first half of 2026, down 33.1 per cent. Xgeva fell from $1,098m to $763m, down 30.5 per cent. In the US alone, Prolia fell from $1,465m to $939m (down 35.9 per cent) and Xgeva from $707m to $415m (down 41.3 per cent). Source: Amgen earnings releases for the first and second quarters of 2025 and 2026; sums are ours; the US figures are from the US column of each release

Q4 2025 The first quarter after the launches began in which Amgen reported both brands down by 10 per cent or more (global sales): Prolia down 10 per cent and Xgeva down 20 per cent, with lower volume cited for both. Source: Amgen fourth quarter and full year 2025 results

Who and what does this page refer to?

Amgen Inc. is the originator of Prolia and Xgeva, which are sold under one biologics license application (BLA), number 125320. The biosimilar sponsors named in the FDA record are Sandoz Inc, Samsung Bioepis Co Ltd, Celltrion Inc, Fresenius Kabi USA LLC, Shanghai Henlius Biotech, Biocon Biologics Inc, Hikma Pharmaceuticals USA Inc, Accord BioPharma Inc, Amneal Pharms LLC and Teva Pharmaceuticals, Inc.

Court and trade records name other entities. The Judicial Panel on Multidistrict Litigation (the Panel) sent the related federal cases to one judge as MDL No. 3138, a multidistrict litigation. The Panel's order names Celltrion, Inc. and Celltrion USA, Inc., four Fresenius Kabi entities, and Accord Biopharma, Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd. The Hikma launch report names Gedeon Richter as developer, and the Henlius settlement report names Organon.

Goodwin's report of the complaints filed on 6 November 2025 names Dr. Reddy's Laboratories and Alvotech as defendants in one and Amneal Pharmaceuticals in the other, and Pearce IP names the second as Amneal/mAbxience.

Large companies operate through several legal entities, often one for each country or function. Press releases, court filings and regulatory records each name the entity that acted in that document, and these are not always the same one. This page uses the name each source gives. It does not treat two named entities as one company, or say that one controls the other, unless a source says so.

How long did denosumab biosimilars take to reach the US?

The first denosumab biosimilar was approved on 5 March 2024. Sandoz announced that its Jubbonti and Wyost were "available to patients in the US starting today" on 2 June 2025, fifteen months later.

A report of the Sandoz settlement says Sandoz and Amgen agreed it in April 2024, a month after approval, resolving the US patent litigation Amgen began in May 2023, with launch permitted from 31 May 2025 (Pearce IP, 2 June 2025). The launch announcement followed that date by two days. The terms of the agreement are not public.

Seven more settlements followed, the last on 31 March 2026, each with its own entry date or none disclosed. That sequence is what the rest of this brief sets out, and it is the record a reader would miss by looking only at the originator's patent table.

When could each US denosumab biosimilar launch?

Exhibit 1 keeps three facts apart that are often written as one: when FDA approved a product, the earliest date the record says the company could sell it, and the date a launch was announced. Approval, permission and launch are different events, and for denosumab they are months apart.

Exhibit 1. Denosumab biosimilar status by sponsor, as at 23 October 2026

Sources: FDA Drugs@FDA via openFDA (approval dates, sponsor names, retrieved 23 October 2026); Judicial Panel on Multidistrict Litigation transfer order, MDL No. 3138, 6 February 2025 (case numbers, consolidation); company releases from Sandoz and Fresenius; law-firm and trade reports from Pearce IP, Venable's BiologicsHQ and Goodwin, named in the cells, which are secondary and report confidential settlements.

Dates in the entry columns are as those outlets report them and are not read from the agreements. Alkem Laboratories Ltd, Ascend Laboratories, LLC and Enzene Biosciences Ltd are reported as defendants in a complaint filed 14 November 2025, and Dr. Reddy's Laboratories and Alvotech in one filed 6 November 2025; no FDA approval record for any of them was found.

Three patterns stand out. Entry did not cluster on one day: the five announced launches span 2 June 2025 to 19 January 2026, about seven and a half months. A permitted date is not a launch date: Celltrion could sell from 1 June and announced on 7 or 8 July, five weeks later, after Fresenius Kabi. And the settlement is not the same as the approval: Accord's consent judgment is reported to bar launch before 1 October 2025, and its FDA approval followed on 29 October.

Which dates governed US denosumab biosimilar entry?

Amgen's Form 10-K for 2025 says its patents for RANKL antibodies, including sequences, for Prolia and Xgeva expired in the United States in February 2025 and in select countries in Europe in November 2025. It also says multiple biosimilars have launched in the United States and the rest of the world. No launch in Exhibit 1 is dated before 2 June 2025.

The settlement dates and the patent expiry are both on the record, and they do not match. Amgen's complaints asserted 29 patents against Celltrion (Goodwin, 5 June 2024), 34 against Biocon (Pearce IP, 30 June 2025) and 35 against Alkem (Goodwin, 21 November 2025) in the reports read. A report of the Accord consent judgment says it also allows entry before the latest-expiring asserted patent. So an expiry named in a 10-K is one input, and the agreed entry date is another.

What the record does not say is which patents governed which date, or why the dates fall where they do. The settlement terms are confidential, and no source read ties the 31 May and 1 June 2025 dates to a specific patent. This brief reports the two sets of dates side by side and does not reconcile them.

How have Prolia and Xgeva sales changed since the launches?

Amgen reports Prolia and Xgeva separately and gives its own reasons for each movement. The totals are global; each release also shows the US portion, which Exhibits 2 and 3 add. Exhibit 2 sets the six quarters from the first quarter of 2025 to the second quarter of 2026 on one scale. The 2025 quarters sum to Amgen's full-year global totals of $4,414m for Prolia and $2,084m for Xgeva, of which the US was $2,978m and $1,355m.

Exhibit 2. Prolia and Xgeva quarterly sales, global and US, US$ millions, first quarter 2025 to second quarter 2026

Source: Amgen earnings releases for each quarter (company filings). Both panels share one scale, and each column shows the global total with the US portion marked. The first US launch announcement (Sandoz, 2 June 2025) falls in the second quarter of 2025; the fifth (Hikma, 19 January 2026) falls in the first quarter of 2026. Amgen reports in US dollars and does not report denosumab biosimilar sales.

Exhibit 3. Global change against the prior-year quarter, US sales, and what Amgen says drove it

Source: Amgen earnings releases for the first quarter of 2025 to the second quarter of 2026. Percentage changes are for global sales, against the same quarter a year earlier as Amgen reports them; the US figures are the US column of each release. Drivers are paraphrased from Amgen's attributions and describe global sales. Amgen's third quarter 2026 results had not been reported as at 23 October 2026. Launch announcements are from Exhibit 1 and are limited to the sources read.

Exhibit 3 shows two things. First, the quarters of the first launches show no steep fall. Prolia was down 4 per cent in the second quarter of 2025 and up 9 per cent in the third; for the third quarter Amgen names favourable changes in estimated sales deductions (14 per cent), partly offset by lower net selling price.

The first double-digit global fall came in the fourth quarter, two quarters after the first announced launch. In the US column, Prolia's larger step came in the first quarter of 2026, from $707m to $461m. Xgeva's US sales fell in the fourth quarter ($357m to $291m) and again in the first ($228m).

Second, the pattern of the drivers changed. In the fourth quarter of 2025 Amgen named price first for Prolia and volume for Xgeva. In the first half of 2026 it names lower volume first for both brands, with lower net selling price second. Amgen's first quarter 2026 release says it continues to expect accelerated sales erosion in 2026 and does not quantify it. Annual figures hide the change: Prolia's full year 2025 was up 1 per cent.

What the register shows, and what it does not

The FDA register lists twelve approved biosimilar applications from ten sponsors, plus Amgen's own application. Every one carries prescription marketing status, which does not establish that a product is on sale. As at 23 October 2026 the register shows no approved denosumab biosimilar from a sponsor named Alkem, Dr. Reddy's or Alvotech. Drugs@FDA does not list applications under review, so this says nothing about any application in progress.

The same limit applies to counts of what is pending. Under 21 CFR 601.51(b), the FDA does not disclose that a biological product file exists before approval unless it "has previously been publicly disclosed or acknowledged". A list of pending denosumab applications can therefore only be built from company announcements and court filings, and this one is.

Amgen's eleventh denosumab action, against Alkem, was reported in November 2025 (Goodwin, 21 November 2025). Two earlier actions, filed on 6 November 2025 in the District of New Jersey, name Dr. Reddy's Laboratories and Alvotech in one and Amneal Pharmaceuticals in the other (Goodwin, 10 November 2025). Pearce IP listed both as pending on 31 March 2026.

Dr. Reddy's Laboratories Limited disclosed that its wholly owned subsidiary, Dr. Reddy's Laboratories SA, had received an FDA complete response letter for its AVT03 application (Medical Dialogues, 1 January 2026, reporting the disclosure). That source does not give the reasons. The reports read give no later status for either action.

This brief covers the United States. Amgen dates the expiry of its European patents to November 2025 in select countries, and European entry dates are not covered here. This brief covers US entry dates and Amgen's reported sales. It does not state when the exclusivity period for Prolia and Xgeva ended, because the date of first licensure that sets it is not established here.

What does the denosumab record show?

• Keep the originator's expiry statement and the entry dates apart. They were months apart on denosumab and came from different records.
• On denosumab, entry came as a sequence, not on one date. Five launches were announced across seven and a half months, and the order was not the order of approval or of permission.
• On denosumab, the fall showed after a lag. Amgen's global Prolia sales first fell by 10 per cent or more in the fourth quarter of 2025, two quarters after the first announced launch, and Amgen reported a favourable change in sales deductions in the quarter between.
• On denosumab, volume led. In the first half of 2026 Amgen put lower volume ahead of lower price for both brands.
• On denosumab, settlement dates were visible and the terms were hidden. Dates reached the public through releases and law-firm reports. Terms stayed confidential, so a tracker is only as good as its sourcing.

LOE Edge reads FDA application records for a molecule, including the Purple Book for biologics, and shows each figure next to its source. Its methodology sets out how each register is read and what it cannot show.

For other molecules read against the same registers, see Vedolizumab biosimilars, a biologic with three announced applications and none licensed; Pembrolizumab loss of exclusivity, a biologic with two FDA licences and no licensed biosimilar; and Rivaroxaban loss of exclusivity, a small molecule whose approvals are on the record while launches mostly are not.

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Related reading

• Vedolizumab biosimilars: Takeda's New Jersey suits and London claims over another biologic.
• Pembrolizumab loss of exclusivity: two FDA licences, two sets of Merck-listed dates.
• Apixaban loss of exclusivity: a small-molecule comparison.

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Methodology and sources

Figures come from Amgen's filings and releases and from FDA records. Amgen's product sales are global totals, and the US portion is taken from the US column of the same releases. Settlement and launch dates come from company releases where they exist and otherwise from law-firm and trade reports, which are named in the text and labelled secondary. No syndicated market research is used and no market size has been estimated. Counts of applications and sponsors come from the FDA register; counts of launches and settlements are counts of public announcements.

• Amgen Inc., Form 10-K for the fiscal year ended 31 December 2025. The first part of the filing was read, about 111,000 characters; the legal proceedings note was not reached. SEC EDGAR.
• Amgen earnings release for the first quarter of 2025. SEC EDGAR.
• Amgen earnings release for the second quarter of 2025. SEC EDGAR.
• Amgen earnings release for the third quarter of 2025. SEC EDGAR.
• Amgen earnings release for the fourth quarter and full year 2025. SEC EDGAR.
• Amgen earnings release for the first quarter of 2026. SEC EDGAR.
• Amgen earnings release for the second quarter of 2026. SEC EDGAR.
• FDA Drugs@FDA application records through openFDA, retrieved 23 October 2026: the thirteen applications referencing denosumab, their sponsors, brands and original approval dates. FDA states openFDA data is unvalidated. openFDA.
• Judicial Panel on Multidistrict Litigation, Transfer Order, In re Denosumab Patent Litigation, MDL No. 3138, 6 February 2025. JPML.
• Sandoz release announcing the US launch of Wyost and Jubbonti, 2 June 2025 (copy on BioSpace). BioSpace.
• Fresenius release announcing the US launch of Conexxence and Bomyntra, 1 July 2025. Business Wire.
• Pearce IP, "Sandoz Launches First Denosumab Biosimilars in US", 2 June 2025 (secondary). Pearce IP.
• Pearce IP, "Celltrion is Third to Launch US Denosumab Biosimilars", 8 July 2025 (secondary). Pearce IP.
• Pearce IP, "Samsung Bioepis & Amgen Settle BPCIA Denosumab Litigation", 5 September 2025 (secondary). Pearce IP.
• Pearce IP, "Biocon Launches Denosumab Biosimilars in US Following Amgen Settlement", 1 October 2025 (secondary). Pearce IP.
• Pearce IP, "Richter/Hikma Launch Denosumab Biosimilars in US", 19 January 2026 (secondary). Pearce IP.
• Pearce IP, "Henlius/Organon Settle US Denosumab Litigation with Amgen", 31 March 2026 (secondary; also lists the actions then pending). Pearce IP.
• Venable's BiologicsHQ, report of the Amgen and Accord consent judgment, July 2025 (secondary). BiologicsHQ.
• Goodwin, "Amgen Files BPCIA Complaint Against Alkem Related to Denosumab Biosimilar", 21 November 2025 (secondary). Goodwin.
• Goodwin, "Amgen Files BPCIA Complaints Against Dr. Reddy's/Alvotech and Amneal Regarding Denosumab Biosimilars", 10 November 2025 (secondary). Goodwin.
• Goodwin, "Amgen Files BPCIA Complaint Against Celltrion Regarding Denosumab", 5 June 2024 (secondary). Goodwin.
• Pearce IP, "Amgen Expands US BPCIA Denosumab Litigation to Include Biocon", 30 June 2025 (secondary). Pearce IP.
• Center for Biosimilars, "Two More Pairs of Denosumab Biosimilars Enter US Market", 9 July 2025 (secondary; gives 7 July 2025 for the Celltrion announcement). Center for Biosimilars.
• Medical Dialogues, report of a Dr. Reddy's stock-exchange disclosure on AVT03, 1 January 2026 (secondary). Medical Dialogues.
• 21 CFR 601.51, confidentiality of data and information in a biological product file. eCFR.

Nothing in this brief is investment advice or a recommendation regarding any security. Amgen does not report denosumab biosimilar sales, so biosimilar share is not disclosed and has not been estimated here.