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Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book. Product and Company page search results are reported for FDA-approved indications, aBLA and 505(b)(2) activity, approved foreign biosimilars, IPRs and U.S. litigations.

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Brand Name

Abecma®ABP 654 Abrilada Actemra®Acthrel®Actimmune®Activase® / Cathflo® Activase®Adakveo®Adbry Adcetris®Adlyxin®Admelog®Aduhelm®Afrezza®Aimovig®Ajovy®Aldurazyme®Alferon N Injection®Alymsys®Amjevita Amphadase®Anthim®Apidra® / Apidra SoloSTAR®Aranesp®Arcalyst®Arzerra® / Kesimpta®Asparlas Avastin®Avonex®Avsola®AVT02 AVT04 Basaglar®BAT1706 Bavencio®Benlysta®Beovu®Besponsa®Besremi®Betaseron®BIIB800 Blenrep®Blincyto®Bonsity®Botox®Bravelle®Brineura Briumvi Byooviz Cablivi®Campath® / Lemtrada®Cerezyme®Chorionic Gonadotropin Cimerli Cimzia®Cinqair®Cosentyx®Creon®Crysvita®Curosurf®Cyltezo®Cyramza®Danyelza®Darzalex Faspro®Darzalex®Daxxify Dupixent®Dysport®Ebanga EG12014 Egrifta®Elahere Elaprase®Elelyso®Elfabrio®Elitek®Elspar®Elzonris®Emgality®Empliciti®Enbrel®Enhertu®Enjaymo Enspryng Entyvio®Epkinly Epogen® / Procrit®Erbitux®Erelzi®Erwinaze®Eticovo®Evenity®Evkeeza®Extavia®Eylea®Fabrazyme®Fasenra®Fiasp®FKB238 Follistim® AQ Forteo®Fortical®Fulphila®Fylnetra Gamifant®Gazyva®Genentech Cabilly Genotropin®GlucaGen®Glucagon®Gonal-f®Gonal-f® RFF Gonal-f® RFF Redi-ject®GP2411 Granix®Grastofil Hadlima Hemlibra®Herceptin Hylecta®Herceptin®Herzuma®HLX02 Hulio®Humalog®Humalog® Mix 50/50 / Humalog® Mix 50/50 KwikPen®Humalog® Mix 75/25 / Humalog® Mix 75/25 KwikPen®Humatrope®Humira®Humulin® R / Humulin® R KwikPen®Hydase®Hylenex®Hyrimoz Idacio®Ilaris®Ilumya®Imfinzi®Imjudo®Increlex®Infasurf®Inflectra®Inmazeb Insulin Lispro (Authorized Generic)Insulin-R Intron A Ixifi Jeanatope®Jemperli®Jetrea®Jeuveau®Kadcyla®Kalbitor®Kanjinti®Kanuma®Kepivance®Kevzara®Keytruda®Kimmtrak®Kineret®Krystexxa®Lamzede®Lantus® / Lantus® SoloSTAR®Lapelga Lartruvo®Leqembi Leukine®Levemir®Levemir® / Levemir® FlexTouch®Libtayo®Lucentis®Lumoxiti®Lunsumio Lusduna Nexvue Lyumjev®M710 Margenza®Megatope®Menopur®Mepsevii®Miacalcin®Mircera®Monjuvi®MSB11456 Mvasi®Myalept®MYL-1402O MYL-1601D Mylotarg®Myobloc®Myozyme® / Lumizyme®Myxredlin®Naglazyme®Natpara®Neulasta®Neumega®Neupogen®NexoBrid®Nexviazyme®Nivestym®Norditropin® FlexPro Novarel®Novolog®Novolog® Mix 70/30 Nplate®Nucala®Nulojix®Nutropin AQ®Nutropin®Nyvepria®Ocrevus®Ogivri®Omnitrope®Oncaspar®Ontak®Ontruzant®Opdivo®Opdualag Orencia®Ovidrel®Oxervate®Padcev®Palynziq®Pancreaze®PB006 Pegasys®Pegfilgrastim (Lupin)PegIntron® / Sylatron®Perjeta®Pertzye®Phesgo®Plegridy®Polivy®Portrazza®Poteligeo®Praluent®Praxbind®Pre-Pen®Pregnyl®Proleukin®Prolia® / Xgeva®ProstaScint®Pulmotech MAA Pulmozyme®Qwo®Raxibacumab®Rebif®Reblozyl®Regranex®Releuko Remicade®Remsima® SC Renflexis®ReoPro®Repatha®Retacrit®Retavase®Revcovi®Rezvoglar Riabni Rituxan Hycela®Rituxan®Rixathon®Rolvedon Ruxience®Rybrevant Rylaze®Ryzodeg® 70/30 Saizen®Santyl®Saphnelo®Sarclisa®SB8 Semglee®Serostim®Siliq®Simponi Aria®Simponi®Simulect®Skyrizi®Skytrofa®Sogroya®Soliqua® 100/33 Soliris®Somavert®Spevigo®Stelara®Stimufend® Strensiq®Sucraid®Survanta®Susvimo Sylvant®Synagis®Takhzyro®Taltz®Tanzeum®Tecentriq®Tecvayli Tepezza®Tezspire®Thyrogen®Tivdak®TNKase®Toujeo Solostar®Trazimera®Tremfya®Tresiba®Trodelvy®Trogarzo®Trulicity®Truxima®TX-01 TX-05 Tysabri®Tzield Udenyca®Ultomiris®Unituxin®Uplizna®Vabysmo Vectibix®Vegzelma®Vimizim®Viokace®Vitrase®Voraxaze®VPRIV®Vyepti®Vyvgart®Wydase®Xenpozyme Xeomin®Xiaflex®Xlucane Xolair®Xultophy® 100/3.6 Yervoy®Yuflyma®Yusimry Zaltrap®Zarxio®Zenapax®Zenpep®Zevalin®Ziextenzo®Zinplava®Zirabev®Zomacton®Zorbtive®Zynlonta®Zynyz

Scientific Name

abatacept abciximab abobotulinumtoxinA adalimumab adalimumab adalimumab-aacf adalimumab-aaty adalimumab-adaz adalimumab-adbm adalimumab-afzb adalimumab-aqvh adalimumab-atto adalimumab-bwwd adalimumab-fkjp ado-trastuzumab emtansine aducanumab-avwa aflibercept aflibercept agalsidase beta albiglutide albumin iodinated I-125 serum albumin iodinated I-131 serum aldesleukin alemtuzumab alglucosidase alfa alirocumab alteplase amivantamab-vmjw anacaulase-bcdb anakinra anifrolumab-fnia ansuvimab-zykl asfotase alfa asparaginase asparaginase erwinia chrysanthemi asparaginase erwinia chrysanthemi (recombinant)-rywn atezolizumab atoltivimab; odesivimab; maftivimab avalglucosidase alfa-ngpt avelumab basiliximab becaplermin belantamab mafodotin-blmf belatacept belimumab benralizumab benzylpenicilloyl polylysine beractant bevacizumab bevacizumab bevacizumab bevacizumab bevacizumab bevacizumab-adcd bevacizumab-awwb bevacizumab-bvzr bevacizumab-maly bezlotoxumab blinatumomab brentuximab vedotin brodalumab brolucizumab-dbll burosumab-twza calaspargase pegol-mknl calcitonin salmon calcitonin salmon calfactant canakinumab caplacizumab-yhdp capromab pendetide cemiplimab-rwlc cenegermin-bkbj cerliponase alfa certolizumab pegol cetuximab chorigonadotropin alfa chorionic gonadotropin chorionic gonadotropin chorionic gonadotropin collagenase collagenase clostridium histolyticum collagenase clostridium histolyticum-aaes corticorelin ovine triflutate crizanlizumab-tmca daclizumab daratumumab daratumumab; hyaluronidase-fihj darbepoetin alfa daxibotulinumtoixnA-lanm denileukin diftitox denosumab denosumab dinutuximab dornase alfa dostarlimab-gxly dulaglutide dupilumab durvalumab ecallantide eculizumab efgartigimod alfa-fcab eflapegrastim-xnst elapegademase-lvlr elosulfase alfa elotuzumab emapalumab-lzsg emicizumab-kxwh enfortumab vedotin-ejfv epcoritamab-bysp epoetin alfa epoetin alfa-epbx eptinezumab-jjmr erenumab-aooe etanercept etanercept-szzs etanercept-ykro evinacumab-dgnb evolocumab fam-trastuzumab deruxtecan-nxki faricimab-svoa filgrastim filgrastim filgrastim filgrastim-aafi filgrastim-ayow filgrastim-sndz follitropin alfa/beta follitropin alfa/beta follitropin alfa/beta follitropin alfa/beta fremanezumab-vfrm galcanezumab-gnlm galsulfase gemtuzumab ozogamicin glucagon glucagon glucarpidase golimumab golimumab guselkumab hyaluronidase hyaluronidase hyaluronidase hyaluronidase hyaluronidase ibalizumab-uiyk ibritumomab tiuxetan idarucizumab idecabtagene vicleucel idursulfase imiglucerase incobotulinumtoxinA inebilizumab infliximab infliximab infliximab-abda infliximab-axxq Infliximab-dyyb infliximab-qbtx inotuzumab ozogamicin insulin aspart insulin aspart insulin aspart protamine recombinant; insulin aspart recombinant insulin aspart recombinant insulin aspart; insulin degludec insulin degludec insulin degludec; liraglutide insulin detemir insulin detemir recombinant insulin glargine insulin glargine insulin glargine recombinant insulin glargine recombinant insulin glargine-aglr insulin glargine-yfgn insulin glargine; lixisenatide insulin glulisine recombinant insulin human insulin human insulin human insulin human recombinant insulin lispro protamine recombinant; insulin lispro recombinant insulin lispro protamine recombinant; insulin lispro recombinant insulin lispro recombinant insulin lispro recombinant insulin lispro recombinant insulin lispro-aabc interferon alfa-2b interferon alfa-n3 interferon beta-1a interferon beta-1a interferon beta-1b interferon beta-1b interferon gamma-1b ipilimumab isatuximab-irfc ixekizumab lanadelumab-flyo laronidase lecanemab-irmb lixisenatide lonapegsomatropin-tcgd loncastuximab tesirine-lpyl luspatercept-aamt margetuximab-cmkb mecasermin recombinant menotropins (FSH;LH)mepolizumab methoxy polyethylene glycol-epoetin beta metreleptin mirvetuximab soravtansine-gynx mogamulizumab-kpkc mosunetuzumab-axgb moxetumomab pasudotox-tdfk natalizumab natalizumab naxitamab-gqgk necitumumab nivolumab nivolumab; elatlimab-rmbw obiltoxaximab obinutuzumab ocrelizumab ocriplasmin ofatumumab olaratumab olipudase alfa-rpcp omalizumab onabotulinumtoxinA oprelvekin palifermin palivizumab pancrelipase (amylase; lipase; protease)pancrelipase (amylase; lipase; protease)pancrelipase (amylase; lipase; protease)pancrelipase (amylase; lipase; protease)pancrelipase (amylase; lipase; protease)panitumumab parathyroid hormone pegaspargase pegfilgrastim pegfilgrastim pegfilgrastim pegfilgrastim-apgf pegfilgrastim-bmez pegfilgrastim-cbqv pegfilgrastim-fpgk pegfilgrastim-jmdb pegfilgrastim-pbbk peginterferon alfa-2a peginterferon alfa-2b peginterferon beta-1a pegloticase pegunigalsidase alfa-iwxj pegvaliase-pqpz pegvisomant pembrolizumab pertuzumab pertuzumab; trastuzumab; hyaluronidase-zzxf polatuzumab vedotin-piiq poractant alfa prabotulinumtoxinA-xvfs ramucirumab ranibizumab ranibizumab ranibizumab-eqrn ranibizumab-nuna ranobizumab rasburicase ravulizumab-cwvz raxibacumab reslizumab reteplase retifanlimab-dlwr rilonacept rimabotulinumtoxinB risankizumab-rzaa rituximab rituximab rituximab-abbs rituximab-arrx rituximab-pvvr rituximab; hyaluronidase romiplostim romosozumab-aqqg ropeginterferon alfa-2b-njft sacituzumab govitecan-hziy sacrosidase sargramostim sarilumab satralizumab sebelipase alfa secukinumab siltuximab somapacitan-beco somatropin somatropin somatropin somatropin somatropin somatropin somatropin somatropin somatropin (rDNA origin)somatropin recombinant spesolimab-sbzo sutimlimab-jome tafasitamab-cxix tagraxofusp-erzs taliglucerase alfa tbo-filgrastim tebentafusp-tebn technetium Tc 99m albumin aggregated teclistamab-cqyv tenecteplase teplizumab-mzwv teprotumumab-trbw teriparatide teriparatide tesamorelin acetate tezepelumab-ekko thyrotropin alfa tildrakizumab-asmn tisotumab vedotin-tftv tocilizumab tocilizumab tocilizumab tralokinumab-ldrm trastuzumab trastuzumab trastuzumab trastuzumab trastuzumab-anns trastuzumab-dkst trastuzumab-dttb trastuzumab-pkrb trastuzumab-qyyp trastuzumab; hyaluronidase-oysk tremelimumab-actl ublituximab urofollitropin ustekinumab ustekinumab ustekinumab vedolizumab velaglucerase alfa velmanase alfa-tycv vestronidase alfa-vjbk ziv-aflibercept

Company Name

ABBOTT ABBVIE ABLYNX ACCORD ACENDIS PHARMA ADC THERAPEUTICS ADVANCE BIOFACTURES AKORN ALEXION ALLERGAN ALLERQUEST ALVOTECH AMGEN AMNEAL AMPHASTAR AMYLIN PHARMS APOTEX ARGENX ASTELLAS ASTRAZENECA AUXILIUM BAUSCH AND LOMB BAXALTA BAXTER HEALTHCARE BAYER HEALTHCARE BECTON DICKINSON BERLEX LABS BIO-THERA BIOCON BIOEQ BIOGEN BIOMARIN BIOVERATIV BIOVITRUM BOEHRINGER INGELHEIM BRISTOL-MYERS SQUIBB BTG INTERNATIONAL CELGENE CELLTECH CELLTRION CENTUS CHENGDU KANGHONG CHIESI CHIRON CHONG KUN DANG CHUGAI CIPLA CIS BIO COHERUS BIOSCIENCES CREALTA PHARMS CREATIVE BIOLABS CYTOGEN DAIICHI SANKYO DIGESTIVE CARE DOMPE FARMACEUTICI DR REDDYS DYAX EIRGENIX EISAI EKR THERAPEUTICS ELAN PHARMACEUTICALS ELI LILLY ELUSYS THERAPEUTICS EMD SERONO ENDO EVOLUS FERRING FRESENIUS KABI FUJI PHARMA MOCHIDA FUJIFILM GALDERMA GENENTECH GENMAB GENZYME GLAXOSMITHKLINE HALOZYME THERAPEUTICS HORIZON THERAPEUTICS HOSPIRA HUGEL HUMAN GENOME SCIENCES HYCLONE LABORATORIES IMCLONE IMMUNEX IMMUNOCORE IMMUNOGEN IMMUNOMEDICS INCYTE INTERFERON SCIENCES IPSEN IPSEN BIOPHARM ISO TEX JANSSEN (CENTOCOR)JAZZ PHARMACEUTICALS JOHNSON AND JOHNSON KASHIV BIOSCIENCES (ADELLO)KYOWA KIRIN LEADIANT BIOSCI LEK PHARMACEUTICALS LEO PHARMA LINDIS BIOTECH LUNDBECK SEATTLE BIOPHARMACEUTICALS LUPIN MABXIENCE MACROGENICS MANNKIND MEDIMMUNE MEDIWOUND MEDY-TOX MERCK MERZ PHARMS MOMENTA PHARMACEUTICALS MORPHOSYS MYLAN NEKTAR NESTLE SKIN HEALTH NOVARTIS NOVEX NOVIMMUNE NOVO NORDISK NPS PHARMS OMJ PHARMACEUTICALS ONO PHARMACEUTICAL ONY ORGANON ORTHO-MCNEIL OSSIFI-MAB PFENEX PFIZER PHARMACIA PHARMAESSENTIA PHIGENIX POLPHARMA PROVENTION BIO QOL MEDICAL REGENERON REVANCE THERAPEUTICS RIDGEBACK BIOTHERAPEUTICS ROCHE (HOFFMANN-LA ROCHE)SAMSUNG BIOEPIS SANDOZ SANOFI SCHERING SEAGEN (SEATTLE GENETICS)SERVIER PHARMA SHANGHAI HENLIUS BIOTECH SHIRE SIGMA TAU SPECTRUM STADA STEMLINE THERAPEUTICS SUN PHARMA SWISS PHARMA INTERNATIONAL TAIMED BIOLOGICS TAKEDA PHARMS TANVEX TASUKU HONJO TEVA TG THERAPEUTICS THERATECHNOLOGIES THROMBOGENICS TX-05 UCB ULTRAGENYX UNIGENE UNITED THERAPEUTICS UPSHER-SMITH VALEANT VIATRIS VIDARA THERAPEUTICS RESEARCH VIELA BIO VIOKACE VIVUS WYETH XBRANE Y-MABS THERAPEUTICS YEDA

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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