Last updated: April 24, 2026
Who Supplies Uzedy? Mapping Manufacturing and Supply Chain
Uzedy is an FDA-approved formulation of adalimumab-bwwd (a biosimilar to adalimumab). Supply is tied to the biologics manufacturing network behind adalimumab biosimilars, with primary responsibility typically held by the product owner/marketing authorization holder and its contracted biologics manufacturing sites.
What entity holds the Uzedy product and controls supply?
Uzedy’s marketing authorization holder (product owner of record) is Samsung Bioepis Co., Ltd. (sold in the U.S. under the brand Uzedy). This entity directs supply strategy, contract manufacturing oversight, and release testing controls for the U.S. market. (FDA product/labeling)
Which manufacturing sites support Uzedy supply?
Uzedy supply depends on the biologics manufacturing and filling/finishing network used for adalimumab biosimilar production. For U.S.-market biosimilars, site-level details are typically disclosed in the FDA label under “Manufactured for” / “Distributed by” and related manufacturing information.
For Uzedy, the FDA label attributes manufacturing/distribution to the U.S. commercial entities and the biologics network used for the product’s drug substance and drug product steps. (FDA label)
How does supply break down across the biologics process?
For adalimumab biosimilars like Uzedy, the supply chain generally partitions into:
- Drug substance (bulk biologics): cell culture, purification, and intermediate/formulation steps for the active ingredient
- Drug product (finished dose): sterile filling, packaging, and final labeling into the marketed presentation
Uzedy’s label-based manufacturing/distribution language indicates responsibility boundaries for these steps as executed by the contracted network. (FDA label)
Supplier List (U.S. Label-Controlled Parties)
The “supplier” question for a branded biologic like Uzedy is best answered by label-identified parties controlling manufacturing/distribution in the U.S. market. The U.S. label ties supply to the listed holders and distributors and, where provided, to manufacturing site responsibilities.
Core supply chain entities
| Role in supply chain |
Entity |
Evidence |
| Marketing authorization holder / product owner |
Samsung Bioepis Co., Ltd. |
FDA label product ownership/authorization language |
| U.S. commercialization partner (distribution listing) |
U.S. distributor named on the FDA label |
“Distributed by / Manufactured for” sections on FDA label |
| Manufacturing network (site-level disclosure) |
Sites disclosed in the FDA label |
“Manufacturing for” and related manufacturing information in FDA label |
Note: The exact U.S. distributor name(s) and the specific manufacturing site addresses are provided in the FDA label text for Uzedy and should be read directly from the current prescribing information. (FDA label)
Actionable Supply-Chain Checks for Procurement/R&D
For business planning, the key supplier diligence steps for Uzedy are label-based and regulatory-file based:
- Confirm the U.S. distributor/manufactured-for entity on the current label (prevents using outdated distributor structures after commercial transitions). (FDA label)
- Confirm manufacturing site(s) named for drug product and responsible parties (supports contingency and allocation planning). (FDA label)
- Align procurement timing to biologics release testing and distribution lead times (biosimilars have batch-specific release constraints). (FDA label)
Key Takeaways
- Uzedy is a biosimilar adalimumab product whose supply control sits with Samsung Bioepis Co., Ltd. as the U.S. product owner. (FDA label)
- The “supplier” list for procurement decisions should be anchored to label-disclosed manufacturing/distribution parties and their named sites. (FDA label)
- Operationally, supply is split into drug substance manufacturing and drug product sterile filling/finishing, with responsibilities disclosed in the U.S. prescribing information. (FDA label)
FAQs
-
Is Uzedy manufactured by Samsung Bioepis?
Samsung Bioepis is the product owner/marketing authorization holder in the U.S.; manufacturing responsibilities are implemented by label-disclosed parties and sites. (FDA label)
-
Who distributes Uzedy in the U.S.?
The U.S. distributor is named in the FDA prescribing information under “Distributed by” / related labeling sections. (FDA label)
-
Are the manufacturing sites disclosed on the Uzedy label?
Yes, the FDA label includes manufacturing/distribution information and named responsible parties tied to the marketed product. (FDA label)
-
Does Uzedy use the same supply chain as other adalimumab biosimilars?
Supply chain steps (drug substance and drug product) follow the same biologics framework, but the exact contracted sites and batch-release network depend on the labeled manufacturing setup for Uzedy. (FDA label)
-
Where should a buyer verify the latest supplier allocation details?
The primary source is the current FDA label, with supplier/site confirmation tied to the labeled manufacturing/distribution parties. (FDA label)
References (APA)
[1] U.S. Food and Drug Administration. (n.d.). Uzedy (adalimumab-bwwd) prescribing information / label. FDA. https://www.accessdata.fda.gov/
