When does Simponi go off patent?
In the US, biosimilars can launch from 2026. Simponi is sold by Johnson & Johnson. The FDA approved the first biosimilars, Bio-Thera's Immgolis, in May 2026, and Accord BioPharma plans a US launch in Q4 2026. Sales include the IV form Simponi Aria.
Simponi's US exclusivity date is based on company guidance. The date comes from the company's own filings or guidance. Secondary patents, new formulations or litigation can still move it. It is a biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.
Approved, waiting to launch The FDA approved Bio-Thera's Immgolis (under the skin) and Immgolis Intri (IV) in May 2026, interchangeable for rheumatoid arthritis and ulcerative colitis. Accord BioPharma plans the US launch in Q4 2026.
Checked October 2026. Sources: Accord BioPharma release · Biosimilars R&R
Company guidance. The FDA approved the first biosimilars, Bio-Thera's Immgolis, in May 2026, and Accord BioPharma plans a US launch in Q4 2026. Sales include the IV form Simponi Aria.
Among past biologics facing biosimilars: Humira's US sales fell to 65% of their 2022 level in its first full year of biosimilars (2023) and 16% two years later; Stelara's US sales fell to 57% of their 2024 level in its first full year of biosimilars (2025). See how past cliffs played out →
Simponi is 2.8% of Johnson & Johnson's 2025 revenue ($2.7B of $94.2B). With Stelara, Xarelto, Opsumit, Darzalex, Tremfya, Invega Sustenna, Imbruvica and Erleada, the drugs tracked here add up to 46% of Johnson & Johnson's revenue losing US exclusivity by 2033. Total includes MedTech.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Simponi is highlighted.