Tremfya (Johnson & Johnson) is expected to face US biosimilar competition from 2031. J&J 10-K: US composition patent family projected to expire in 2031. Sales grew 40% in 2025, which J&J attributes to share gains and market growth.
Tremfya'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.
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 →
In clinical trials Celltrion won approval in Korea for a first trial of its Tremfya biosimilar in July 2026. Samsung Bioepis, Alvotech and Polpharma also have programs.
| Company (product) | Stage |
|---|---|
| Celltrion (CT-P68) | Phase 1 approved in Korea (Jul 2026) |
| Samsung Bioepis | Early development |
| Alvotech | Early development |
| Polpharma (PB019) | Early development |
Checked September 2026. Sources: Pearce IP: Celltrion trial
Tremfya is 5.5% of Johnson & Johnson's 2025 revenue ($5.2B of $94.2B). With Stelara, Darzalex and Imbruvica, the drugs tracked here add up to 30% of Johnson & Johnson's revenue losing US exclusivity by 2032. Total includes MedTech.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Tremfya is highlighted.