Biosimilar Trends
207 FDA-approved biosimilars across 132 reference products
207
Total Biosimilars
FDA approved
132
Reference Products
With biosimilar competition
41
Approved in 2025
YTD approvals
96
Active Companies
In biosimilar market
Biosimilar Approvals by Year
1
2015
3
2016
6
2017
24
2018
20
2019
16
2020
15
2021
21
2022
22
2023
36
2024
41
2025
2
2026
Most Competitive Reference Products
DENOSUMAB
JUBBONTI, WYOST, DENOSUMAB-DSSB +16 more
19
biosimilars
ADALIMUMAB
AMJEVITA, CYLTEZO, HYRIMOZ +7 more
10
biosimilars
USTEKINUMAB
WEZLANA, SELARSDI, PYZCHIVA +5 more
8
biosimilars
PEGFILGRASTIM
FULPHILA, UDENYCA, ZIEXTENZO +4 more
7
biosimilars
TRASTUZUMAB
OGIVRI, HERZUMA, ONTRUZANT +3 more
6
biosimilars
AFLIBERCEPT
YESAFILI, OPUVIZ, AHZANTIVE +3 more
6
biosimilars
BEVACIZUMAB
MVASI, ZIRABEV, ALYMSYS +3 more
6
biosimilars
INFLIXIMAB
INFLECTRA, RENFLEXIS, IXIFI +2 more
5
biosimilars
FILGRASTIM
ZARXIO, NIVESTYM, RELEUKO +2 more
5
biosimilars
RITUXIMAB
TRUXIMA, RUXIENCE, RIABNI
3
biosimilars
RANIBIZUMAB
BYOOVIZ, CIMERLI, NUFYMCO
3
biosimilars
INSULIN ASPART
MERILOG, MERILOG SOLOSTAR, KIRSTY
3
biosimilars
TOCILIZUMAB
TOFIDENCE, TYENNE, AVTOZMA
3
biosimilars
INSULIN GLARGINE
SEMGLEE, REZVOGLAR
2
biosimilars
ECULIZUMAB
BKEMV, EPYSQLI
2
biosimilars
Leading Biosimilar Companies
Novartis
11
Amgen
11
SAMSUNG BIOEPIS CO LTD
11
Pfizer
10
CELLTRION INC
8
Eli Lilly
6
BIOCON BIOLOGICS INC
6
Fresenius Kabi
6
Roche
5
Sanofi
5
Recent Biosimilar Approvals (Last 2 Years)
| Biosimilar | Reference | Company | Approval Date |
|---|---|---|---|
| LOARGYS | PEGZILARGINASE | IMMEDICA PHARMA AB | Feb 23, 2026 |
| FILKRI | FILGRASTIM | ACCORD BIOPHARMA INC. | Jan 15, 2026 |
| YARTEMLEA | NARSOPLIMAB | OMEROS CORP | Dec 23, 2025 |
| BONCRESA | DENOSUMAB | AMNEAL PHARMS LLC | Dec 19, 2025 |
| OZILTUS | DENOSUMAB | AMNEAL PHARMS LLC | Dec 19, 2025 |
| NUFYMCO | RANIBIZUMAB | FORMYCON AG | Dec 18, 2025 |
| EXDENSUR | DEPEMOKIMAB | GSK | Dec 16, 2025 |
| LEROCHOL | LERODALCIBEP | LIB THERAPEUTICS, INC. | Dec 12, 2025 |
| ARMLUPEG | PEGFILGRASTIM | Lupin | Nov 28, 2025 |
| VOYXACT | SIBEPRENLIMAB | OTSUKA PHARM CO LTD | Nov 25, 2025 |
| POHERDY | PERTUZUMAB | SHANGHAI HENLIUS BIOTECH | Nov 13, 2025 |
| OSVYRTI | DENOSUMAB | ACCORD BIOPHARMA INC. | Oct 29, 2025 |
| JUBEREQ | DENOSUMAB | ACCORD BIOPHARMA INC. | Oct 29, 2025 |
| BLENREP | BELANTAMAB MAFODOTIN | GSK | Oct 23, 2025 |
| EYDENZELT | AFLIBERCEPT | CELLTRION INC | Oct 2, 2025 |
| ENOBY | DENOSUMAB | Hikma | Sep 26, 2025 |
| XTRENBO | DENOSUMAB | Hikma | Sep 26, 2025 |
| AUKELSO | DENOSUMAB | BIOCON BIOLOGICS INC | Sep 16, 2025 |
| BOSAYA | DENOSUMAB | BIOCON BIOLOGICS INC | Sep 16, 2025 |
| BILPREVDA | DENOSUMAB | SHANGHAI HENLIUS BIOTECH | Aug 29, 2025 |
Showing 20 of 74 recent approvals
About Biosimilars
Biosimilars are biologic products highly similar to an FDA-approved reference product with no clinically meaningful differences. They're identified by a 4-letter suffix in their generic name (e.g., adalimumab-atto). The first biosimilar was approved in 2015, and the market has grown rapidly as patents on major biologics expire.