Kesimpta (Novartis) is expected to face US biosimilar competition from 2031. Novartis 20-F: US compound patent 2031 (already expired in Europe). Multiple sclerosis; sales grew 37% in 2025.
Kesimpta'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 →
Early development Alvotech is developing a Kesimpta biosimilar, licensed to Advanz for Europe in 2025. We found no US filing.
| Company (product) | Stage |
|---|---|
| Alvotech | Early development (Europe partner: Advanz) |
Checked September 2026. Sources: Pearce IP: Alvotech and Advanz
Kesimpta is 8.1% of Novartis's 2025 revenue ($4.4B of $54.5B). With Entresto, Cosentyx and Kisqali, the drugs tracked here add up to 43% of Novartis's revenue losing US exclusivity by 2031.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Kesimpta is highlighted.