January 2027
Amgen ocrelizumab biosimilar Phase 3 results expected
Amgen is the furthest along of the US-focused developers.
When does Ocrevus go off patent?
In the US, biosimilars can launch from 2029. Ocrevus is sold by Roche. Main US patent protection runs to March 2029. Sales CHF 7.01B.
Ocrevus's US exclusivity date is based on patent-expiry estimate. It is estimated from patent expiry rather than a fixed entry date, so it may move as patents are challenged or extended. It is a biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.
| Patent or protection | Covers | Expiry |
|---|---|---|
| US biologic exclusivity (12 years) | Ocrelizumab, from its first approval in March 2017 | March 2029 |
| Main US patent protection, per Roche | Ocrevus | March 2029 |
| Ocrevus Zunovo patents | The under-the-skin version approved in 2024 | Not disclosed |
Roche puts the end of Ocrevus's main US protection in March 2029, when its 12-year biologic exclusivity also runs out. As with Keytruda, the defence is a second product: Ocrevus Zunovo, an under-the-skin version given in about 10 minutes, which Roche says is driving growth in Europe and the US. Amgen is furthest along among biosimilar developers, with Phase 3 results expected in January 2027.
Sources: Roche Finance Report 2025 · FDA Purple Book
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2023 | CHF 6.4B | CHF 4.7B | – |
| 2024 | CHF 6.7B | CHF 4.8B | +6% |
| 2025 | CHF 7.0B | CHF 4.9B | +4% |
Worldwide net sales as reported, with the US share, in CHF as the company reports them, so growth is not distorted by exchange rates. Source: Roche Finance Reports 2025 and 2024
In clinical trials Amgen is furthest along among US-focused developers, with Phase 3 results expected in January 2027. Teva has licensed Polpharma's candidate, which starts its first trial in October 2026.
| Company (product) | Stage |
|---|---|
| Amgen (ABP 692) | In clinical trials. Phase 3 results expected Jan 2027 |
| CinnaGen (Xacrel) | In clinical trials. Phase 3 reported; US plans unclear |
| Polpharma / Teva (PB018) | Early development. Phase 1 planned for Oct 2026 |
Checked October 2026. Sources: Teva press release · Biosimilars R&R
Among past biologics facing biosimilars, US sales in the first full year after copies arrived were a median 65% of the last full year before (range 34% to 93%, 7 drugs), and 27% by the third year (9 drugs). Biosimilars usually take share more gradually than generics. Every drug is different: settlements, how many copies launch, and pricing all change the curve. See the erosion benchmarks →
| Scenario | 2025 US sales | Year 1 (about 2030) | Year 2 | Year 3 |
|---|---|---|---|---|
| Fastest past case | CHF 4.87B | CHF 1.66B34% | CHF 0.52B11% | CHF 0.21B4% |
| Median | CHF 4.87B | CHF 3.18B65% | CHF 1.87B38% | CHF 1.30B27% |
| Slowest past case | CHF 4.87B | CHF 4.55B93% | CHF 3.69B76% | CHF 3.10B64% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Ocrevus's 2025 US sales, held flat until copies arrive in 2029. Year 1 is the first full year with copies on sale.
Ocrevus is 11% of Roche's 2025 revenue (≈$8.4B of $74.1B). With Xolair, Perjeta, Tecentriq 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.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Ocrevus is highlighted.
Amgen is the furthest along of the US-focused developers.
Biosimilars are in development; Amgen is furthest along.