Samsung Bioepis sells US copies of 2 of the blockbuster drugs on this tracker, is approved for 2 more, and has 5 filed or in development. Those brands earned $79.0B in 2025. Of the 70 makers we follow, 7 are lined up to copy more of these drugs.
| Drug | Samsung Bioepis' status | Other makers listed | 2025 brand sales |
|---|---|---|---|
| Stelara PyzchivaBiosimilar · Johnson & Johnson · US LOE 2025 | FDA-approved 28 Jun 2024; launched Feb 2025; interchangeable With Sandoz |
7 on sale · 0 approvedof 7 other makers listed | $6.1B |
| Prolia OspomyvBiosimilar · Amgen · US LOE 2025 | FDA-approved 13 Feb 2025; launched 2026; interchangeable. Sold in the US under a private label by Cordavis (CVS Health) | 6 on sale · 3 approvedof 10 other makers listed | $4.4B |
| Drug | Samsung Bioepis' status | Other makers listed | 2025 brand sales |
|---|---|---|---|
| Xgeva XbrykBiosimilar · Amgen · US LOE 2025 | FDA-approved 13 Feb 2025; interchangeable | 6 on sale · 3 approvedof 10 other makers listed | $2.1B |
| Enbrel EticovoBiosimilar · Amgen · US LOE 2029 | FDA-approved 25 Apr 2019; interchangeable; barred by court until 2029 | 0 on sale · 1 approvedof 1 other maker listed | $2.2B |
| Drug | Samsung Bioepis' status | Other makers listed | 2025 brand sales |
|---|---|---|---|
| Keytruda SB27Biosimilar · Merck · US LOE 2028 | In clinical trials. Phase 3 complete; filed in Korea, Aug 2026 | 0 on sale · 0 approvedof 9 other makers listed | $31.7B |
| Taltz SB35Biosimilar · Eli Lilly · US LOE 2030 | In clinical trials. Phase 1 started Aug 2026 | 0 on sale · 0 approvedof 2 other makers listed | $3.6B |
| DupixentBiosimilar · Sanofi / Regeneron · US LOE 2031 | Early development | 0 on sale · 0 approvedof 2 other makers listed | $17.8B |
| TremfyaBiosimilar · Johnson & Johnson · US LOE 2031 | Early development | 0 on sale · 0 approvedof 3 other makers listed | $5.2B |
| EntyvioBiosimilar · Takeda · US LOE 2032 | Early development. Announced Jan 2026 | 0 on sale · 0 approvedof 2 other makers listed | ≈$6.0B |
Copies not yet on sale, by the earliest year each could reach the US market: a settlement or court date where one is public, otherwise the brand's US exclusivity date. "Now" means that date has passed. Court rulings and new patents can move these.
The brand owner's US sales, as it reports them. They show how fast copies took the market, not Samsung Bioepis' own sales. See the launch tracker →
Each row is a copy Samsung Bioepis sells, holds an approval for, has filed, or is developing, for one of the 63 blockbuster drugs this site tracks. It is not Samsung Bioepis' full portfolio. "Other makers listed" counts the other companies on the same drug's list: how many sell a copy and how many more hold an approval. Brand owners and the FDA don't always name every filer, so a list can be incomplete; the drug page says so where we know.
2025 sales are what each brand earned, the size of the market at stake. They are not Samsung Bioepis' sales; several makers usually share a market once copies launch.
Every row is sourced on its drug's page: FDA Orange Book and Purple Book approvals, company releases and filings for launches, and court and company records for settlements. Company facts: Business Wire; Samsung Epis Holdings: 2025 results, Samsung Epis Holdings: Q2 and H1 2026 results.