When does Xolair go off patent?
It already has: US biosimilars have been on sale since 2026. Xolair is sold by Roche and Novartis. Celltrion launched Omlyclo, the first US biosimilar, on 5 October 2026 under a settlement with Genentech. Sales: Roche in the US (CHF 3.08B, up 32% on food allergy use) plus Novartis elsewhere ($1.72B).
Xolair's US exclusivity date is based on biosimilars launched. US biosimilars have already launched, so the loss of exclusivity is under way. It is a biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.
Copies on the US market Celltrion launched Omlyclo, an interchangeable biosimilar, on 5 October 2026 at a list price about 15% below Xolair, with a preferred spot on Optum's commercial formulary. Alvotech and Kashiv are developing another.
| Company (product) | Stage |
|---|---|
| Celltrion (Omlyclo) | Launched 5 Oct 2026; interchangeable |
| Alvotech / Kashiv (AVT23) | In development |
From the FDA's own approval lists; FDA approval does not always mean a product has launched. Checked October 2026. Sources: Celltrion launch release · Pearce IP
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 →
Xolair was selected for the Medicare Drug Price Negotiation Program. CMS is negotiating its Medicare price now; the price takes effect in 2028 and is due to be published by 30 November 2026. US biosimilars had already launched by then. For the 25 drugs negotiated so far, Medicare prices came in 38% to 85% below list price. Those discounts are measured before the rebates drugmakers already pay and apply to Medicare only.
Xolair is 5% of Roche's 2025 revenue (≈$3.7B of $74.1B). With Perjeta, Tecentriq, Ocrevus and Vabysmo, the drugs tracked here add up to 34% of Roche's revenue losing US exclusivity by 2034. Group sales CHF 61.5B, including Diagnostics.
Xolair is 3.2% of Novartis's 2025 revenue (≈$1.7B of $54.5B). With Entresto, Cosentyx, Kisqali and Kesimpta, the drugs tracked here add up to 46% of Novartis's revenue losing US exclusivity by 2031.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Xolair is highlighted.