⚠ Generic Apremilast Arrives in EuropeHigh threat

Amgen (AMGN) — threat to the moat

Otezla is a pill, so copies arrive fast, and they reached Europe in early 2026, two years before its American patents end.

Otezla's American price is heading to Medicare; its European sales are already being copied. The second-quarter 2026 10-Q says Otezla ROW sales were unfavorably impacted by generic competition following loss of exclusivity in certain European countries during the first quarter of 20261.

Sensipar sales after loss of exclusivity ($M)1,774201855120192882020642022Amgen Form 10-K FY2019; FY2020 and FY2022 results releases
What generics did to Amgen's last pill.

A pill is copied more easily than a biologic. Otezla is a small molecule, so a generic needs only to show the same drug is absorbed the same way; there is no need for the large trials a biosimilar requires. When copies arrive, prices fall quickly, as Amgen's own history with Sensipar shows: after it lost exclusivity, the 10-K says, Amgen lost a significant share of the market and corresponding revenues in a very short period of time2. Sensipar sold $1,774 million in 2018 and $64 million in 202234.

In the United States the protection is longer. Otezla's composition patents run to February 2028, with pediatric exclusivity to August 20285. After that date the Sensipar pattern applies at home too, only a year after Medicare's price takes effect.

The second-quarter result, sales down 21% to $491 million6, contains both forces: the European generics and weaker American prices. The drug has perhaps two more years of protected American sales.

The test of this threat is Otezla's international sales line. If Europe's decline spreads across the rest of the world in 2026, the $1.2 billion impairment will prove too small, and the remaining carrying value will face another write-down before 2028.

References
  1. ReportedThe second-quarter 2026 10-Q says Otezla ROW sales were unfavorably impacted by generic competition following loss of exclusivity in certain European countries during the first quarter of 2026.
    Amgen Form 10-Q for the quarter ended 30 June 2026 - product sales, the TAVNEOS proceeding, the IRS dispute, the BeOne stake and the balance sheet. — Q2 2026 · publ. 5 August 2026 · source ↗
  2. ReportedWhen copies arrive, prices fall quickly, as Amgen's own history with Sensipar shows: after it lost exclusivity, the 10-K says, Amgen lost a significant share of the market and corresponding revenues in a very short period of time.
    Amgen Form 10-K for fiscal 2025 - Item 1 patents, biosimilars and competitors. — FY2025 · publ. 13 February 2026 · source ↗
  3. ReportedSensipar sold $1,774 million in 2018 and $64 million in 2022.
    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 ↗
  4. ReportedSensipar sold $1,774 million in 2018 and $64 million in 2022.
    Amgen fourth-quarter and full-year 2022 results release, Form 8-K exhibit 99.1 - product sales and other revenues for 2021-2022. — FY2022 · publ. February 2023 · source ↗
  5. ReportedOtezla's composition patents run to February 2028, with pediatric exclusivity to August 2028.
    Amgen Form 10-K for fiscal 2025 - Item 1 patents, biosimilars and competitors. — FY2025 · publ. 13 February 2026 · source ↗
  6. ReportedThe second-quarter result, sales down 21% to $491 million, contains both forces: the European generics and weaker American prices.
    Amgen second-quarter 2026 results release, Form 8-K exhibit 99.1 - product sales performance: inflammation, rare disease and established products, and sales by region. — Q2 2026 · publ. 4 August 2026 · source ↗
Sources
Generated September 28, 2026