| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 761343 | BLA | ALVOTECH USA INC | 001 | SELARSDI | INJECTABLE;INJECTION | 45MG/0.5ML | USTEKINUMAB-AEKN | 2024-04-16 | Prescription | No | |
| 002 | SELARSDI | INJECTABLE;INJECTION | 90MG/ML | USTEKINUMAB-AEKN | 2024-04-16 | Prescription | No | ||||
| 761299 | BLA | ALVOTECH USA INC | 001 | SIMLANDI | INJECTABLE;INJECTION | 40MG/0.4ML | ADALIMUMAB-RYVK | 2024-02-23 | Prescription | No |