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Live Biologics & Biosimilar Intelligence

Live openFDA Data — Searching Biologics License Applications

Pyzchiva

Mfr: Samsung Bioepis Co Ltd

BLA761373

Route of Admin

Injection

Active Ingredient

Ustekinumab-Ttwe

Submission Status: AP (20240628)

Follistim Aq

Mfr: Organon Usa Llc

BLA021211

Route of Admin

Subcutaneous

Active Ingredient

Follitropin Alfa/Beta

Submission Status: AP (20151109)

Leqembi Iqlik

Mfr: Eisai Inc

BLA761375

Route of Admin

Subcutaneous

Active Ingredient

Lecanemab-Irmb

Submission Status: AP (20260713)

Unknown Biologic

Mfr: Dr Reddys Labs Sa

BLA761376

Route of Admin

Unknown Route

Active Ingredient

Unknown Ingredient

Submission Status: AP (20260731)

Levemir Flextouch

Mfr: Novo Nordisk Inc

BLA021536

Route of Admin

Subcutaneous

Active Ingredient

Insulin Detemir Recombinant

Submission Status: AP (20140225)

Eydenzelt

Mfr: Celltrion Inc

BLA761377

Route of Admin

Injection

Active Ingredient

Aflibercept-Boav

Submission Status: AP (20251002)

Myalept

Mfr: Chiesi Farmaceutici Spa

BLA125390

Route of Admin

Injection

Active Ingredient

Metreleptin

Submission Status: AP (20140224)

Unknown Biologic

Mfr: Halozyme Therap

BLA761313

Route of Admin

Unknown Route

Active Ingredient

Unknown Ingredient

Submission Status: AP (20230620)

Adcetris

Mfr: Seattle Genetics

BLA125399

Route of Admin

Injection

Active Ingredient

Brentuximab Vedotin

Submission Status: AP (20110819)

Alhemo

Mfr: Novo Nordisk Inc

BLA761315

Route of Admin

Subcutaneous

Active Ingredient

Concizumab-Mtci

Submission Status: AP (20241220)

Perjeta

Mfr: Genentech

BLA125409

Route of Admin

Single-Use

Active Ingredient

Pertuzumab

Submission Status: AP (20160322)

Lytenava

Mfr: Outlook Therapeutics, Inc.

BLA761320

Route of Admin

Single-Dose

Active Ingredient

Bevacizumab-Vikg

Submission Status: AP (20260724)

Hylenex Recombinant

Mfr: Halozyme Therap

BLA021859

Route of Admin

Injection

Active Ingredient

Hyaluronidase Recombinant Human

Submission Status: AP (20120301)

Zaltrap

Mfr: Sanofi Aventis Us

BLA125418

Route of Admin

Injection

Active Ingredient

Ziv-Aflibercept

Submission Status: AP (20131025)

Tyruko

Mfr: Sandoz Inc

BLA761322

Route of Admin

Injection

Active Ingredient

Natalizumab-Sztn

Submission Status: AP (20260723)

Jetrea

Mfr: Thrombogenics, Inc

BLA125422

Route of Admin

Intravitreal

Active Ingredient

Ocriplasmin

Submission Status: AP (20160327)

Epkinly

Mfr: Genmab Us, Inc.

BLA761324

Route of Admin

Subcutaneous

Active Ingredient

Epcoritamab-Bysp

Submission Status: AP (20240626)

Pregnyl

Mfr: Organon Usa Llc

BLA017692

Route of Admin

Injection

Active Ingredient

Gonadotropin, Chorionic

Submission Status: AP (19940218)

Kadcyla

Mfr: Genentech

BLA125427

Route of Admin

Single-Use

Active Ingredient

Ado-Trastuzumab Emtansine

Submission Status: AP (20250514)

Merilog

Mfr: Sanofi-Aventis U.S. Llc

BLA761325

Route of Admin

Solution

Active Ingredient

Insulin Aspart-Szjj

Submission Status: AP (20250214)

Tanzeum

Mfr: Glaxosmithkline Llc

BLA125431

Route of Admin

Injection

Active Ingredient

Albiglutide

Submission Status: AP (20171212)

Awiqli Flextouch

Mfr: Novo Nordisk Inc

BLA761326

Route of Admin

Solution

Active Ingredient

Insulin Icodec

Submission Status: AP (20260326)

Simponi Aria

Mfr: Janssen Biotech

BLA125433

Route of Admin

Injection

Active Ingredient

Golimumab

Submission Status: AP (20171020)

Beyfortus

Mfr: Astrazeneca Ab

BLA761328

Route of Admin

Injection

Active Ingredient

Nirsevimab-Alip

Submission Status: AP (20240223)

Vimizim

Mfr: Biomarin Pharm

BLA125460

Route of Admin

Injection

Active Ingredient

Elosulfase Alfa

Submission Status: AP (20251030)