| Application Number | Application Type | Drug Name | Active Ingredients | Dosage Form/Route | Approval Date | Company |
|---|---|---|---|---|---|---|
| 761425 | BLA | PYZCHIVA | USTEKINUMAB-TTWE | INJECTABLE;SUBCUTANEOUS | SAMSUNG BIOEPIS CO LTD | |
| 761411 | BLA | NIKTIMVO | axatilimab-csfr | INJECTABLE;INTRAVENOUS | INCYTE CORP | |
| 761390 | BLA | NEMLUVIO | NEMOLIZUMAB-ILTO | INJECTABLE;INJECTION | GALDERMA LABS LP | |
| 761388 | BLA | PIASKY | CROVALIMAB-AKKZ | INJECTABLE;INTRAVENOUS | GENENTECH INC | |
| 761382 | BLA | ENZEEVU | AFLIBERCEPT-ABZV | INJECTABLE;INJECTION | SANDOZ INC | |
| 761378 | BLA | AHZANTIVE | AFLIBERCEPT-MRBB | INJECTABLE;INJECTION | FORMYCON AG | |
| 761373 | BLA | PYZCHIVA | USTEKINUMAB-TTWE | INJECTABLE;INJECTION | SAMSUNG BIOEPIS CO LTD | |
| 761363 | BLA | WINREVAIR | SOTATERCEPT-CSRK | INJECTABLE;INJECTION | MERCK SHARP DOHME | |
| 761362 | BLA | JUBBONTI | DENOSUMAB-BBDZ | INJECTABLE;SUBCUTANEOUS | SANDOZ INC | |
| 761359 | BLA | ENTYVIO | VEDOLIZUMAB | INJECTABLE;INTRAVENOUS | TAKEDA PHARMS USA | |
| 761358 | BLA | ZYMFENTRA | INFLIXIMAB-DYYB | INJECTABLE;INJECTION | CELLTRION | |
| 761355 | BLA | EYLEA HD | AFLIBERCEPT | INJECTABLE;INJECTION | REGENERON PHARMACEUTICALS | |
| 761354 | BLA | TOFIDENCE | TOCILIZUMAB-BAVI | INJECTABLE;INJECTION | BIOGEN MA | |
| 761350 | BLA | OPUVIZ | AFLIBERCEPT-YSZY | INJECTABLE;INJECTION | SAMSUNG BIOEPIS CO LTD | |
| 761349 | BLA | COSENTYX | SECUKINUMAB | INJECTABLE;INJECTION | NOVARTIS PHARMS CORP | |
| 761346 | BLA | HERCESSI | TRASTUZUMAB-STRF | INJECTABLE;INJECTION | ACCORD BIOPHARMA INC. | |
| 761345 | BLA | ELREXFIO | ELRANATAMAB | SOLUTION;INJECTION | PFIZER INC | |
| 761344 | BLA | IMDELLTRA | TARLATAMAB-DLLE | INJECTABLE;INJECTION | AMGEN INC | |
| 761343 | BLA | SELARSDI | USTEKINUMAB-AEKN | INJECTABLE;INJECTION | ALVOTECH USA INC | |
| 761342 | BLA | TALVEY | TALQUETAMAB-TGVS | INJECTABLE;INJECTION | JANSSEN BIOTECH |