Licensed biological products
Biological therapeutics cannot be evaluated under the small-molecule bioequivalence framework. Instead, the Public Health Service Act splits them into 351(a) standalone innovator products and 351(k) biosimilars — a subset of which are additionally designated interchangeable, meaning a pharmacy may substitute them without the prescriber's intervention.
779 products · page 1 of 4 · source: FDA Purple Book
All types 779 351(a) 2,000 351(k) Interchangeable 138 351(k) Biosimilar 104 License Type 1
A.P.L. · chorionic gonadotropin 351(a) CDER 3 presentations Abecma · idecabtagene vicleucel 351(a) CBER 2 presentations Abrilada · adalimumab-afzb Interchangeable CDER 5 presentations Abrysvo · Respiratory Syncytial Virus Vaccine 351(a) CBER 1 presentation Acam2000 · Smallpox (Vaccinia) Vaccine, Live 351(a) CBER 1 presentation Accretropin · somatropin 351(a) CDER 1 presentation Actemra · tocilizumab 351(a) CDER 5 presentations Acthib,Omnihib · Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) 351(a) CBER 1 presentation Acthrel · corticorelin ovine triflutate 351(a) CDER 1 presentation Actimmune · interferon gamma-1b 351(a) CDER 1 presentation Activase · alteplase 351(a) CDER 2 presentations Adacel · Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed 351(a) CBER 1 presentation Adagen · pegademase bovine 351(a) CDER 1 presentation Adakveo · crizanlizumab-tmca 351(a) CDER 1 presentation Adbry · tralokinumab-ldrm 351(a) CDER 2 presentations Adcetris · brentuximab vedotin 351(a) CDER 1 presentation Adlyxin · lixisenatide 351(a) CDER 2 presentations Admelog · insulin lispro 351(a) CDER 3 presentations Adstiladrin · nadofaragene firadenovec-vncg 351(a) CBER 1 presentation Aduhelm · aducanumab-avwa 351(a) CDER 2 presentations Advate · Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method 351(a) CBER 7 presentations Adynovate · Antihemophilic Factor (Recombinant), PEGylated 351(a) CBER 7 presentations Adzynma · ADAMTS13, recombinant-krhn 351(a) CBER 2 presentations Afluria, Afluria Quadrivalent · Influenza Vaccine 351(a) CBER 5 presentations Afrezza · insulin human 351(a) CDER 3 presentations Afstyla · Antihemophilic Factor (Recombinant), Single Chain 351(a) CBER 7 presentations Agriflu · Influenza Virus Vaccine 351(a) CBER 1 presentation Ahzantive · aflibercept-mrbb Biosimilar CDER 2 presentations Aimovig · erenumab-aooe 351(a) CDER 4 presentations Ajovy · fremanezumab-vfrm 351(a) CDER 2 presentations Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 · Albumin (Human) 351(a) CBER 8 presentations Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 · Albumin (Human) 351(a) CBER 8 presentations Albuminex · Albumin (Human)-kjda 351(a) CBER 4 presentations Alburx · Albumin (Human) 351(a) CBER 4 presentations Albutein · Albumin (Human) 351(a) CBER 9 presentations Aldurazyme · laronidase 351(a) CDER 1 presentation Alferon N Injection · interferon alfa-n3 (human leukocyte derived) 351(a) CDER 1 presentation Alhemo · concizumab-mtci 351(a) CDER 3 presentations Allocord · HPC, Cord Blood 351(a) CBER 1 presentation Alphanate · Antihemophilic Factor/von Willebrand Factor Complex (Human) 351(a) CBER 5 presentations Alphanine, Alphanine Hp, Alphanine Sd · Coagulation Factor IX (Human) 351(a) CBER 4 presentations Alprolix · Coagulation Factor IX (Recombinant), Fc Fusion Protein 351(a) CBER 6 presentations Altuviiio · antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl 351(a) CBER 7 presentations Alyglo · immune globulin intravenous, human-stwk 351(a) CBER 1 presentation Alymsys · bevacizumab-maly Biosimilar CDER 2 presentations Amevive · alefacept 351(a) CDER 2 presentations Amjevita · adalimumab-atto Interchangeable CDER 9 presentations Amphadase · hyaluronidase 351(a) CDER 1 presentation Amtagvi · Lifileucel 351(a) CBER 1 presentation Anascorp · Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection 351(a) CBER 1 presentation Anavip · Crotalidae Immune F(ab')2 (Equine) 351(a) CBER 1 presentation Andembry · garadacimab-gxii 351(a) CDER 2 presentations Andexxa · Coagulation Factor Xa (Recombinant), Inactivated-zhzo 351(a) CBER 2 presentations Anktiva · nogapendekin alfa inbakicept-pmln 351(a) CDER 1 presentation Anthim · obiltoxaximab 351(a) CDER 1 presentation Anthrasil · Anthrax Immune Globulin Intravenous (Human) 351(a) CBER 1 presentation Antivenin (Latrodectus mactans) · Antivenin (Latrodectus mactans) 351(a) CBER 2 presentations Antivenin (Micrurus fulvius) · Antivenin (Micrurus fulvius) 351(a) CBER 1 presentation Apidra · insulin glulisine 351(a) CDER 3 presentations Aplisol · Tuberculin, Purified Protein Derivative 351(a) CBER 1 presentation Aralast, Aralast Np · Alpha-1-Proteinase Inhibitor (Human) 351(a) CBER 2 presentations Aranesp · darbepoetin alpha 351(a) CDER 49 presentations Arcalyst · rilonacept 351(a) CDER 1 presentation Arepanrix · Influenza A [H5] Monovalent Vaccine, Adjuvanted 351(a) CBER 1 presentation Arexvy · Respiratory Syncytial Virus Vaccine, Adjuvanted 351(a) CBER 1 presentation Armlupeg · pegfilgrastim-unne Biosimilar CDER 1 presentation Artiss · Fibrin Sealant (Human) 351(a) CBER 6 presentations Arzerra · ofatumumab 351(a) CDER 2 presentations Asceniv · Immune Globulin Intravenous, Human-slra 351(a) CBER 1 presentation Asparlas · calaspargase pegol-mknl 351(a) CDER 1 presentation Atgam · Lymphocyte Immune Globulin, Anti-thymocyte Globulin (Equine) 351(a) CBER 1 presentation Atryn · Antithrombin (Recombinant) 351(a) CBER 2 presentations Attenuvax · Measles Virus Vaccine Live 351(a) CBER 1 presentation Aucatzyl · Obecabtagene autoleucel 351(a) CBER 1 presentation Audenz · Influenza A (H5N1) Monovalent Vaccine, Adjuvanted 351(a) CBER 1 presentation Aukelso · denosumab-kyqq Interchangeable CDER 1 presentation Autoplex, Feiba Nf, Feiba Vh · Anti-Inhibitor Coagulant Complex 351(a) CBER 5 presentations avance nerve graft · acellular nerve allograft-arwx 351(a) CBER 1 presentation Avastin · bevacizumab 351(a) CDER 2 presentations Avlayah · tividenofusp alfa-eknm 351(a) CDER 1 presentation Avonex · interferon beta-1a 351(a) CDER 3 presentations Avsola · infliximab-axxq Biosimilar CDER 1 presentation Avtozma · tocilizumab-anoh Biosimilar CDER 5 presentations Avzivi · bevacizumab-tnjn Biosimilar CDER 2 presentations Awiqli · insulin icodec-abae 351(a) CDER 3 presentations BabyBig · Botulism Immune Globulin Intravenous (Human) 351(a) CBER 1 presentation Balfaxar · Prothrombin complex concentrate, human-lans 351(a) CBER 2 presentations Basaglar · insulin glargine 351(a) CDER 2 presentations Bat · Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) 351(a) CBER 1 presentation Bavencio · avelumab 351(a) CDER 1 presentation Baygam, Gamastan S/D · Immune Globulin (Human) 351(a) CBER 1 presentation Bayhep B, Hyperhep B S/D · Hepatitis B Immune Globulin (Human) 351(a) CBER 5 presentations Bayrab, Hyperrab · Rabies Immune Globulin (Human) 351(a) CBER 2 presentations Bayrab,Hyperrab · Rabies Immune Globulin (Human) 351(a) CBER 1 presentation Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose · Rho(D) Immune Globulin (Human) 351(a) CBER 2 presentations Baytet, Hypertet · Tetanus Immune Globulin (Human) 351(a) CBER 1 presentation Benefix · Coagulation Factor IX (Recombinant) 351(a) CBER 5 presentations Benlysta · belimumab 351(a) CDER 4 presentations Beovu · brolucizumab-dbll 351(a) CDER 2 presentations Beqvez · fidanacogene elaparvovec-dzkt 351(a) CBER 1 presentation Berinert · C1 Esterase Inhibitor (Human) 351(a) CBER 1 presentation Besponsa · inotuzumab ozogamicin 351(a) CDER 1 presentation Besremi · ropeginterferon alfa-2b-njft 351(a) CDER 2 presentations Betaseron · interferon beta-1b 351(a) CDER 1 presentation Bexsero · Meningococcal Group B Vaccine 351(a) CBER 1 presentation Bexxar · tositumomab and iodine I-131 tositumomab 351(a) CDER 2 presentations Beyfortus · nirsevimab-alip 351(a) CDER 2 presentations Bildyos · denosumab-nxxp Interchangeable CDER 2 presentations Bilprevda · denosumab-nxxp Interchangeable CDER 1 presentation Bimzelx · bimekizumab-bkzx 351(a) CDER 4 presentations Bioclate (Armour), Recombinate · Antihemophilic Factor (Recombinant) 351(a) CBER 5 presentations Biorab · Rabies Vaccine Adsorbed 351(a) CBER 1 presentation Biothrax · Anthrax Vaccine Adsorbed 351(a) CBER 2 presentations Bivigam · Immune Globulin Intravenous (Human) 351(a) CBER 2 presentations Bizengri · zenocutuzumab-zbco 351(a) CDER 1 presentation Bkemv · eculizumab-aeeb Interchangeable CDER 1 presentation Blenrep · belantamab mafodotin-blmf 351(a) CDER 2 presentations Blincyto · blinatumomab 351(a) CDER 1 presentation Bomyntra · denosumab-bnht Interchangeable CDER 2 presentations Boncresa · denosumab-mobz Interchangeable CDER 1 presentation Boostrix · Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed 351(a) CBER 2 presentations Bosaya · denosumab-kyqq Interchangeable CDER 1 presentation Botox · onabotulinumtoxinA 351(a) CDER 3 presentations Botox Cosmetic · onabotulinumtoxinA 351(a) CDER 2 presentations Bravelle · urofollitropin 351(a) CDER 1 presentation Breyanzi · lisocabtagene maraleucel 351(a) CBER 1 presentation Brineura · cerliponase alfa 351(a) CDER 1 presentation Briumvi · ublituximab-xiiy 351(a) CDER 1 presentation Buminate, Flexbumin · Albumin (Human) 351(a) CBER 5 presentations Byooviz · ranibizumab-nuna Interchangeable CDER 1 presentation Cablivi · caplacizumab-yhdp 351(a) CDER 1 presentation Campath · alemtuzumab 351(a) CDER 2 presentations Candin · Candida albicans Skin Test Antigen for Cellular Hypersensitivity 351(a) CBER 1 presentation Capvaxive · Pneumococcal 21-valent Conjugate Vaccine 351(a) CBER 1 presentation Carimune, Carimune Nf, Panglobulin, Sandoglobulin · Immune Globulin Intravenous (Human) 351(a) CBER 3 presentations Carticel Sm Service · Autologous Cultured Chondrocytes 351(a) CBER 1 presentation Carvykti · ciltacabtagene autoleucel 351(a) CBER 1 presentation Casgevy · Exagamglogene autotemcel 351(a) CBER 1 presentation Cathflo Activase · alteplase 351(a) CDER 1 presentation Ceprotin · Protein C Concentrate (Human) 351(a) CBER 2 presentations Cerezyme · imiglucerase 351(a) CDER 2 presentations Cervarix · Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant 351(a) CBER 1 presentation Chorionic Gonadotropin · chorionic gonadotropin 351(a) CDER 6 presentations Chromalbin · albumin chromated CR-51 serum 351(a) CDER 3 presentations Chymodiactin · chymopapain 351(a) CDER 2 presentations Cimerli · ranibizumab-eqrn Interchangeable CDER 2 presentations Cimzia · certolizumab pegol 351(a) CDER 2 presentations Cinqair · reslizumab 351(a) CDER 1 presentation Cinryze · C1 Esterase Inhibitor (Human) 351(a) CBER 1 presentation Clevecord · HPC, Cord Blood 351(a) CBER 1 presentation Cnj-016 · Vaccinia Immune Globulin Intravenous (Human) 351(a) CBER 1 presentation Coagadex · Coagulation Factor X (Human) 351(a) CBER 2 presentations Columvi · glofitamab-gxbm 351(a) CDER 2 presentations Comirnaty · COVID-19 Vaccine, mRNA 351(a) CBER 6 presentations Comvax · Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine 351(a) CBER 1 presentation Conexxence · denosumab-bnht Interchangeable CDER 1 presentation Cordcyte · HPC, Cord Blood 351(a) CBER 1 presentation Corifact · Factor XIII Concentrate (Human) 351(a) CBER 1 presentation Cosentyx · secukinumab 351(a) CDER 7 presentations Cotazym · pancrelipase 351(a) CDER 1 presentation Creon · pancrelipase 351(a) CDER 5 presentations Crofab · Crotalidae Polyvalent Immune Fab (Ovine) 351(a) CBER 1 presentation Crosseal, Evicel · Fibrin Sealant (Human) 351(a) CBER 3 presentations Crysvita · burosumab-twza 351(a) CDER 3 presentations Curosurf · poractant alfa 351(a) CDER 2 presentations Cutaquig · Immune Globulin Subcutaneous (Human)-hipp 351(a) CBER 6 presentations Cuvitru · Immune Globulin Subcutaneous (Human), 20% Solution 351(a) CBER 5 presentations Cyfendus · Anthrax Vaccine Adsorbed, Adjuvanted 351(a) CBER 1 presentation Cyltezo · adalimumab-adbm Interchangeable CDER 6 presentations Cyramza · ramucirumab 351(a) CDER 2 presentations Cytogam · Cytomegalovirus Immune Globulin Intravenous (Human) 351(a) CBER 1 presentation Danyelza · naxitamab-gqgk 351(a) CDER 1 presentation Daptacel · Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed 351(a) CBER 1 presentation Darzalex · daratumumab 351(a) CDER 2 presentations Darzalex Faspro · daratumumab and hyaluronidase-fihj 351(a) CDER 1 presentation Datroway · datopotamab deruxtecan-dlnk 351(a) CDER 1 presentation Daxxify · daxibotulinumtoxinA-lanm 351(a) CDER 2 presentations Decnupaz · pivekimab sunirine-pvzy 351(a) CDER 1 presentation Dengvaxia · Dengue Tetravalent Vaccine, Live 351(a) CBER 1 presentation Digibind · Digoxin Immune Fab (Ovine) 351(a) CBER 1 presentation Digifab · Digoxin Immune Fab (Ovine) 351(a) CBER 1 presentation Draximage MAA · kit for the preparation of technetium Tc-99m albumin aggregated 351(a) CDER 1 presentation Ducord · HPC, Cord Blood 351(a) CBER 1 presentation Dupixent · dupilumab 351(a) CDER 6 presentations Dysport · abobotulinumtoxinA 351(a) CDER 2 presentations Ebanga · ansuvimab-zykl 351(a) CDER 1 presentation Ebglyss · lebrikizumab-lbkz 351(a) CDER 2 presentations Egrifta · tesamorelin 351(a) CDER 1 presentation Egrifta SV · tesamorelin 351(a) CDER 1 presentation Egrifta WR · tesamorelin 351(a) CDER 1 presentation Elahere · mirvetuximab soravtansine-gynx 351(a) CDER 1 presentation Elaprase · idursulfase 351(a) CDER 1 presentation Elase-chloromycetin · fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol 351(a) CDER 1 presentation Elelyso · taliglucerase alfa 351(a) CDER 1 presentation Elevidys · delandistrogene moxeparvovec-rokl 351(a) CBER 1 presentation Elfabrio · pegunigalsidase alfa-iwxj 351(a) CDER 2 presentations Elitek · rasburicase 351(a) CDER 2 presentations Eloctate · Antihemophilic Factor (Recombinant), Fc Fusion protein 351(a) CBER 10 presentations Elrexfio · elranatamab-bcmm 351(a) CDER 2 presentations Elspar · asparaginase 351(a) CDER 1 presentation