By Knitify Market Intelligence Team • Radar Desk
May 26, 2026 • 3 min read
Biosimilar approval cadence — Purple Book
| Year | Biosimilar approvals | YoY growth |
|---|
| 2022 | 20 | — |
| 2023 | 32 | +60% |
| 2024 | 50 | +56% |
| 2025 | 51 | +2% |
| 2026 (through April) | 2 | partial year |
| 4-year total | 155 | — |
Where the filings are concentrating
| Reference biologic | Approvals 2022–2026 |
|---|
| adalimumab | 35 |
| ustekinumab | 35 |
| denosumab | 21 |
| tocilizumab | 13 |
| aflibercept | 11 |
| bevacizumab | 8 |
| filgrastim | 8 |
| pegfilgrastim | 5 |
| insulin aspart | 4 |
| ranibizumab | 4 |
Who's getting them approved
| Rank | Applicant | Approvals 2022–2026 |
|---|
| 1 | Celltrion | 23 |
| 2 | Sandoz | 18 |
| 3 | Fresenius Kabi USA | 16 |
| 4 | Amgen | 15 |
| 5 | Samsung Bioepis | 14 |
| 6 | Biocon Biologics | 12 |
| 7 | Accord BioPharma | 9 |
| 8 | Alvotech USA | 9 |
| Top-8 subtotal | | 116 (75% of all) |
A tight oligopoly of biosimilar developers competing hardest on a
handful of reference biologics. For pricing-power modeling and
channel-strategy teams, that asymmetry — concentrated challengers,
concentrated targets — is the entire commercial setup heading into
the next 24 months.
Editorial commentary on publicly available regulatory and public-database data. Not investment, legal, regulatory, or medical advice.