⚠ The ENBREL Copies Waiting to LaunchModerate threat

Amgen (AMGN) — threat to the moat

American ENBREL biosimilars are already approved and wait only for patents that end in 2028 and 2029.

Amgen's biosimilar business sells copies of others; the same industry is waiting to copy ENBREL. The 10-K says companies have launched versions of EPOGEN, NEUPOGEN, Neulasta and ENBREL (Canada only) with U.S. ENBREL biosimilars approved but not launched1. What keeps them off the American market is patents: the fusion protein to November 2028 and the DNA and methods of making to April 20292.

Neulasta sales after biosimilars ($M)4,53420173,22120191,734202184820234352025Amgen Form 10-K FY2019; FY2021, FY2023 and FY2025 results releases
What copies did to Neulasta.

Those patents are being challenged in another way. Sandoz, a biosimilar maker, filed an action in April 2025 claiming violations of the antitrust laws and tortious interference related to Amgen's patent rights to ENBREL3. A biosimilar rival arguing that the patents themselves were used unlawfully is a more direct threat than a patent suit.

Amgen's own history shows what happens when copies do arrive. Neulasta, which now faces copies4, sold $4,534 million in 2017 and $435 million in 202556, down about 90%7.

ENBREL's sales are already low, $2,226 million in 20258, because of price. A biosimilar launch in 2029 would take most of what remains.

Canada shows what waits. The 10-K lists etanercept biosimilars among ENBREL's competitors there9, because copies are already on sale in that market; America is held back only by the patent dates.

The date to watch is November 2028. If the Sandoz action succeeds or the patents fall earlier, ENBREL's copies could launch before then, and the drug would move from slow decline to the Neulasta pattern within two or three years.

References
  1. ReportedThe 10-K says companies have launched versions of EPOGEN, NEUPOGEN, Neulasta and ENBREL (Canada only) with U.S. ENBREL biosimilars approved but not launched.
    Amgen Form 10-K for fiscal 2025 - Item 1 patents, biosimilars and competitors. — FY2025 · publ. 13 February 2026 · source ↗
  2. ReportedWhat keeps them off the American market is patents: the fusion protein to November 2028 and the DNA and methods of making to April 2029.
    Amgen Form 10-K for fiscal 2025 - Item 1 patents, biosimilars and competitors. — FY2025 · publ. 13 February 2026 · source ↗
  3. ReportedSandoz, a biosimilar maker, filed an action in April 2025 claiming violations of the antitrust laws and tortious interference related to Amgen's patent rights to ENBREL.
    Amgen Form 10-K for fiscal 2025 - Item 1A risk factors, government pricing and legal proceedings including the IRS dispute. — FY2025 · publ. 13 February 2026 · source ↗
  4. ReportedNeulasta, which now faces copies, sold $4,534 million in 2017 and $435 million in 2025, down about 90%.
    Amgen Form 10-K for fiscal 2025 - Item 1 patents, biosimilars and competitors. — FY2025 · publ. 13 February 2026 · source ↗
  5. ReportedNeulasta, which now faces copies, sold $4,534 million in 2017 and $435 million in 2025, down about 90%.
    Amgen Form 10-K for fiscal 2019 - selected financial data for 2015-2019, product sales for 2017-2019 and the 2017 Tax Act charge. — FY2019 · publ. February 2020 · source ↗
  6. ReportedNeulasta, which now faces copies, sold $4,534 million in 2017 and $435 million in 2025, down about 90%.
    Amgen fourth-quarter and full-year 2025 results release, Form 8-K exhibit 99.1 - product sales for 2024-2025, non-GAAP EPS and 2026 guidance. — FY2025 · publ. 3 February 2026 · source ↗
  7. Moat Explorer calcNeulasta, which now faces copies, sold $4,534 million in 2017 and $435 million in 2025, down about 90%.
    Moat Explorer calculation from Amgen's reported product sales and financial statements ($ millions unless stated). Sales deductions: 2019 rebates 6,825 + chargebacks 7,090 + other 1,292 = 15,207; 2025 21,697 + 16,988 + 3,298 = 41,983; 41,983 / 35,148 = 1.19 times net product sales; implied gross product sales 35,148 + 41,983 = 77,131. Growth 2019-2025: deductions 41,983 / 15,207 = 2.76 times; net product sales 35,148 / 22,204 = 1.58 times (up 58%); rebates 21,697 / 6,825 = 3.18 times; chargebacks 16,988 / 7,090 = 2.4 times. Wholesalers 2025 gross: 26,253 + 20,986 + 12,562 = 59,801; 59,801 / 36,751 = 1.63 times total revenues; McKesson 26,253 / 36,751 = 71%. ENBREL: 2,226 / 5,433 - 1 = -59%; share of product sales 5,226 / 22,204 = 23.5% (2019), 2,226 / 35,148 = 6.3% (2025). ENBREL + Otezla 2025: 2,226 + 2,265 = 4,491; 4,491 / 36,751 = 12%. Otezla sales 2020-2025: 2,195 + 2,249 + 2,288 + 2,188 + 2,126 + 2,265 = 13,311; impairment 1,200 / 13,400 = 9%. Horizon products: 2023 448 + 272 + 65 + 164 = 949; 2024 1,851 + 1,185 + 379 + 758 = 4,173; 2025 1,903 + 1,340 + 655 + 719 = 4,617, 4,617 / 27,800 = 16.6%; Q2 2026 576 + 400 + 335 + 149 = 1,460, x4 = 5,840. TEPEZZA + KRYSTEXXA 2025 1,903 + 1,340 = 3,243; KRYSTEXXA 1,340 / 1,185 - 1 = 13.1%; TEPEZZA 1,903 / 1,851 - 1 = 2.8%; UPLIZNA 655 / 379 - 1 = 72.8%; H1 2026 262 + 335 = 597; ultra-rare 719 / 758 - 1 = -5.1%; UPLIZNA + ultra-rare 655 + 719 = 1,374. TAVNEOS H1 2026 119 + 150 = 269. Acquisitions: 13.4 + 3.9 + 27.8 = 45.1 bn; acquired products 2025 2,265 + 459 + 4,617 = 7,341, 7,341 / 36,751 = 20%. Interest 2,755 / 9,080 = 30%. Net debt 30 June 2026: 57.3 - 13.989 = 43.3 bn. Goodwill + intangibles 18,680 + 22,276 = 40,956, 40,956 / 90,586 = 45%. EPS gap 21.84 - 14.23 = 7.61. R&D 7,272 / 4,784 - 1 = 52%; 7,272 / 36,751 = 19.8%. Growth drivers 2025: Repatha 3,016 + EVENITY 2,100 + TEZSPIRE 1,478 + BLINCYTO 1,559 = 8,153 (2024: 2,222 + 1,563 + 972 + 1,216 = 5,973; 2023: 1,635 + 1,160 + 567 + 861 = 4,223; 2021: 1,117 + 530 + 0 + 472 = 2,119; 2019: 661 + 189 + 0 + 312 = 1,162); 8,153 / 5,973 - 1 = 36.5%, about 37%; 8,153 / 36,751 = 22%. Repatha 3,016 / 661 = 4.6 times, 3,016 / 2,222 - 1 = 36%; EVENITY 2,100 / 189 = 11 times; BLINCYTO 1,559 / 312 = 5.0 times. KYPROLIS 1,412 / 1,503 - 1 = -6%; KYPROLIS + Nplate 1,412 + 1,524 = 2,936, 2,936 / 6,660 = 44%; BLINCYTO + IMDELLTRA 1,559 + 627 = 2,186; Q2 2026 472 + 288 = 760. IMDELLTRA run rate 288 x 4 = 1,152, 1,152 / 6,498 = 18%. Biosimilars: 2025 AMJEVITA 597 + PAVBLU 700 + WEZLANA 273 + MVASI 771 + in other products 683 = 3,024; 3,024 / 35,148 = 8.6% of product sales; 3,024 / 36,751 = 8.2% of total revenues; PAVBLU 700 / 3,024 = 23%; AMJEVITA 597 / 761 - 1 = -22%; band 2022 1,831 / 2,177 - 1 = -16%; in other products 683 / 667 - 1 = 2%; WEZLANA and other biosimilars added (273 - 27) + (683 - 667) = 262; Q2 2026 155 + 287 + 61 + 153 + 199 = 855; Q2 2025 133 + 130 + 35 + 191 + 172 = 661; 855 / 661 - 1 = 29%; shares of total revenues 568 / 23,362 = 2.4% (2019), 2,177 / 25,979 = 8.4% (2021), 1,916 / 28,190 = 6.8% (2023). Bands 2025: general medicine and bone 3,016 + 2,100 + 4,414 + 2,084 = 11,614 (31.6%); inflammation and rare disease 2,226 + 2,265 + 1,478 + 1,903 + 1,340 + 655 + 459 + 719 = 11,045 (30.1%); oncology 1,559 + 627 + 1,175 + 1,412 + 363 + 1,524 = 6,660 (18.1%); biosimilars 3,024 (8.2%); established and other 1,389 + 435 + 353 + (1,311 - 683 = 628) + 1,603 = 4,408 (12.0%); total 36,751. 2019 bands 5,457; 5,404; 2,895; 568; 9,038; total 23,362. General medicine 11,614 / 5,457 = 2.1 times, 11,614 / 10,384 - 1 = 11.8%; inflammation 2020 7,191, 2024 10,870 / 7,535 - 1 = 44%, 2025 11,045 / 10,870 - 1 = 1.6%, non-ENBREL-Otezla 11,045 - 4,491 = 6,554; oncology 6,660 / 2,895 = 2.3 times, 6,660 / 5,685 - 1 = 17.2%; established 4,408 / 9,038 = 0.49. Q2 bands 2026 vs 2025: general medicine 953 + 714 + 759 + 352 = 2,778 vs 696 + 518 + 1,122 + 532 = 2,868, down 3%; Repatha + EVENITY 1,667 vs 1,214; denosumab 1,111 vs 1,654, down 33%; inflammation 3,167 vs 604 + 618 + 342 + 505 + 349 + 176 + 110 + 183 = 2,887, up 9.7%; oncology 1,953 vs 384 + 134 + 305 + 378 + 90 + 369 = 1,660, up 17.7%; established and other 632 + (351 - 199) + 517 = 1,301 vs 359 + 82 + 92 + (334 - 172) + 408 = 1,103, up 18%. Denosumab 2025 4,414 + 2,084 = 6,498, 6,498 / 36,751 = 17.7%; Q1 2026 727 + 411 = 1,138; H1 2026 1,486 + 763 = 2,249 vs 2,221 + 1,098 = 3,319. Neulasta 435 / 4,534 - 1 = -90%. Geography: US 25,656 / 35,148 = 73%; rest of world 9,492 / 35,148 = 27.0%; Q2 2026 2,547 / 9,537 = 26.7%; AMJEVITA 129 / 155 = 83.2%; Aranesp 258 / 352 = 73.3%; ENBREL 6 / 580 = 1.0%. Novartis-facing 2025 3,016 + 2,265 + 2,226 + 1,524 + 1,478 = 10,509, 10,509 / 36,751 = 29%. Other revenues 1,603 / 36,751 = 4.4%. Receivables 9,570 / 6,782 - 1 = 41%. Guidance midpoints: (37.0 + 38.4) / 2 = 37.7; (37.1 + 38.5) / 2 = 37.8; (38.2 + 39.4) / 2 = 38.8; non-GAAP EPS (22.30 + 23.50) / 2 = 22.90. IRS: 3.6 + 5.1 + 2.0 = 10.7 bn before interest; offsets 0.9 + 2.2 = 3.1 bn; 10.7 / 7.711 = 1.4 times 2025 net income; 10.7 / 224.15 = 4.8% of market value. Trailing free cash flow 8,100 - 2,891 + 4,966 = 10,175; 10,175 / 224,150 = 4.5%. Shares 538.8 / 629.6 - 1 = -14%. Gross margin (total revenues - cost of sales) / total revenues: (28,190 - 8,451) / 28,190 = 70.0% (2023); (33,424 - 12,858) / 33,424 = 61.5% (2024); (36,751 - 12,037) / 36,751 = 67.2% (2025). Pre-tax income 2025 7,711 + 1,265 = 8,976. Total revenues 36,751 / 21,662 = 1.70 times 2015. Market value 224.15 / 176.25 - 1 = 27% in 2026; added 224.15 - 176.25 = 47.9 bn against 176.25 - 122.45 = 53.8 bn in 2015-2025. Trailing net income 7,711 - 3,162 + 4,194 = 8,743; trailing revenue 36,751 - 17,328 + 18,672 = 38,095 - product and band totals, growth and sales deductions. — 2015-2026 · publ. September 2026 · source ↗
    Method: Arithmetic on figures reported in Amgen's Forms 10-K, 10-Q, results releases and market data; operands shown in the source line.
  8. ReportedENBREL's sales are already low, $2,226 million in 2025, because of price.
    Amgen fourth-quarter and full-year 2025 results release, Form 8-K exhibit 99.1 - product sales for 2024-2025, non-GAAP EPS and 2026 guidance. — FY2025 · publ. 3 February 2026 · source ↗
  9. ReportedThe 10-K lists etanercept biosimilars among ENBREL's competitors there, because copies are already on sale in that market; America is held back only by the patent dates.
    Amgen Form 10-K for fiscal 2025 - Item 1 patents, biosimilars and competitors. — FY2025 · publ. 13 February 2026 · source ↗
Sources
Generated September 28, 2026