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

Abecma®Abecma®ABP 938AbriladaAccofil®Actemra®Acthrel®Actimmune®Activase® / Cathflo® Activase®Adakveo®AdbryAdcetris®Adlyxin®Admelog® / Admelog SoloStar®Adstiladrin®Aduhelm®Afrezza®Aimovig®Ajovy®Aldurazyme®Alferon N Injection®AllocordAlymsys®AmjevitaAmphadase®AmtagviAnthim®Apidra® / Apidra SoloSTAR®Aranesp®Arcalyst®Arzerra® / Kesimpta®AsparlasAvastin®Avonex®Avsola®AVT04Avzivi®Basaglar®Bavencio®Benlysta®Beovu®Besponsa®Besremi®Betaseron®BeyfortusBimzelx®Blenrep®Blincyto®Bmab 1200Bonsity®Botox®Bravelle®Breyanzi®BrineuraBriumviByoovizCablivi®Campath® / Lemtrada®Carvykti®CasgevyCerezyme®Chorionic GonadotropinCimerliCimzia®Cinqair®Clevecord®ColumviCosentyx®Creon®Crysvita®CT-P41CT-P42CT-P43CT-P47Curosurf®Cyltezo®Cyramza®Danyelza®Darzalex Faspro®Darzalex®DaxxifyDMB-3115Draximage® MAADRL_RIDucord®Dupixent®Dysport®EbangaEG12014Egrifta®ElahereElaprase®Elelyso®Elevidys®Elfabrio®Elitek®ElrexfioElspar®Elzonris®Emgality®Empliciti®Enbrel®Enhertu®EnjaymoEnspryngEntyvio®EpkinlyEpogen® / Procrit®Erbitux®Erelzi®Erwinaze®Eticovo®Evenity®Evkeeza®Extavia®Eylea®Eylea® HDFabrazyme®Fasenra®Fiasp®FKB238Follistim® AQForteo®Fortical®Fulphila®FYB203FylnetraGamifant®Gazyva®Genentech CabillyGenotropin®GintuitGlucaGen®Glucagon®Gonal-f®Gonal-f® RFFGonal-f® RFF Redi-ject®Granix®GrastofilHadlimaHemacord®Hemgenix®Hemlibra®Herceptin Hylecta®Herceptin®Herzuma®HLX02HPC, Cord BloodHPC, Cord BloodHPC, Cord BloodHPC, Cord BloodHulio®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®Imlygic®Increlex®Infasurf®Inflectra®InmazebInsulin Lispro (Authorized Generic)Insulin-RIntron AIxifiJeanatope®Jemperli®Jetrea®Jeuveau®Jubbonti® / Wyost®Kadcyla®Kalbitor®Kanjinti®Kanuma®Kepivance®Kevzara®Keytruda®Kimmtrak®Kineret®Krystexxa®Kymriah®Lamzede®LantidraLantus® / Lantus® SoloSTAR®LapelgaLartruvo®LavivLeqembiLetybo®Leukine®Levemir®Levemir® / Levemir® FlexTouch®Libtayo®LoqtorziLucentis®Lumoxiti®LunsumioLusduna NexvueLuxturna®Lyfgenia®Lyumjev®M710Maci®Margenza®Megatope®Menopur®Mepsevii®Miacalcin®Mircera®Monjuvi®Mvasi®Myalept®MYL-1402O MYL-1601DMylotarg®Myobloc®Myozyme® / Lumizyme®Myxredlin®Naglazyme®Natpara®Neulasta®Neumega®Neupogen®NexoBrid®Nexviazyme®NgenlaNivestym®Norditropin® FlexProNovarel®Novolog®Novolog® Mix 70/30Nplate®Nucala®Nulojix®Nutropin AQ®Nutropin®Nyvepria®Ocrevus®Ogivri®Omisirge®Omnitrope®OmvohOncaspar®Ontak®Ontruzant®Opdivo®OpdualagOrencia®Ovidrel®Oxervate®Padcev®Palynziq®Pancreaze®Pegasys®Pegfilgrastim (Lupin)PegIntron® / Sylatron®PelgrazPerjeta®Pertzye®Phesgo®Plegridy®Polivy®PombilitiPortrazza®Poteligeo®Praluent®Praxbind®Pre-Pen®Pregnyl®Proleukin®Prolia® / Xgeva®ProstaScint®Provenge®Pulmotech MAAPulmozyme®Qwo®Raxibacumab®Rebif®Reblozyl®Regranex®Releuko®Remicade®Renflexis®ReoPro®Repatha®Retacrit®Retavase®Rethymic®Revcovi®RezvoglarRiabniRituxan Hycela®Rituxan®Rixathon®RoctavianRolvedonRuxience®RybrevantRylaze®Rystiggo®Ryzneuta®Ryzodeg® 70/30 Saizen®Santyl®Saphnelo®Sarclisa®SB12SB15SB17SB8Semglee®Serostim®Siliq®Simlandi®Simponi Aria®Simponi®Simulect®Skyrizi®Skysona®Skytrofa®Sogroya®Soliqua® 100/33Soliris®Somavert®Spevigo®Stelara®Stimufend® Stratagraft®Strensiq®Sucraid®Survanta®SusvimoSylvant®Synagis®Takhzyro®Taltz®TalveyTanzeum®Tecartus®Tecentriq®TecvayliTepezza®Teriparatide ApotexTeriparatide TevaTezspire®Thyrogen®Tivdak®TNKase®TofidenceToujeo Solostar®Trazimera®Tremfya®Tresiba®Trodelvy®Trogarzo®Trulicity®Truxima®TX-01TX-05Tyenne®Tyruko®Tysabri®TzieldUdenyca®Ultomiris®Unituxin®Uplizna®Vabysmo®Vectibix®Vegzelma®VeopozVimizim®Viokace®Vitrase®Voraxaze®VPRIV®Vyepti®Vyjuvek®Vyvgart®Vyvgart® HytruloWezlanaWydase®XenpozymeXeomin®Xiaflex®XlucaneXolair®Xultophy® 100/3.6Yervoy®Yescarta®Yuflyma®YusimryZaltrap®Zarxio®Zenapax®Zenpep®Zevalin®Ziextenzo®Zinplava®Zirabev®Zolgensma®Zomacton®Zorbtive®ZymfentraZynlonta®Zynteglo®Zynyz
abataceptabciximababobotulinumtoxinAadalimumabadalimumab-aacfadalimumab-aatyadalimumab-adazadalimumab-adbmadalimumab-afzbadalimumab-aqvhadalimumab-attoadalimumab-bwwdadalimumab-fkjpadalimumab-ryvkado-trastuzumab emtansineaducanumab-avwaafliberceptafliberceptafliberceptafliberceptafliberceptafliberceptafliberceptagalsidase betaalbiglutidealbumin iodinated I-125 serumalbumin iodinated I-131 serumaldesleukinalemtuzumabalglucosidase alfaalirocumaballogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsatAllogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagenallogeneic processed thymus tissue-agdcalteplaseamivantamab-vmjwanacaulase-bcdbanakinraanifrolumab-fniaansuvimab-zyklasfotase alfaasparaginaseasparaginase erwinia chrysanthemiasparaginase erwinia chrysanthemi (recombinant)-rywnatezolizumabatoltivimab; odesivimab; maftivimabAutologous Cultured Chondrocytes on a Porcine Collagen Membraneavalglucosidase alfa-ngptavelumabaxicabtagene ciloleucelAzficel-Tbasiliximabbecaplerminbelantamab mafodotin-blmfbelataceptbelimumabbenralizumabbenzylpenicilloyl polylysineberactantberemagene geperpavecbetibeglogene autotemcelbevacizumabbevacizumabbevacizumabbevacizumabbevacizumab-adcdbevacizumab-awwbbevacizumab-bvzrbevacizumab-malybevacizumab-tnjnbezlotoxumabbimekizumab-bkzxblinatumomabbrentuximab vedotinbrexucabtagene autoleucelbrodalumabbrolucizumab-dbllburosumab-twzacalaspargase pegol-mknlcalcitonin salmoncalcitonin salmoncalfactantcanakinumabcaplacizumab-yhdpcapromab pendetidecemiplimab-rwlccenegermin-bkbjcerliponase alfacertolizumab pegolcetuximabchorigonadotropin alfachorionic gonadotropinchorionic gonadotropinchorionic gonadotropinciltacabtagene autoleucelcipaglucosidase alfa-atgacollagenasecollagenase clostridium histolyticumcollagenase clostridium histolyticum-aaescorticorelin ovine triflutatecrizanlizumab-tmcadaclizumabdaratumumabdaratumumab; 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insulin aspart recombinantinsulin aspart recombinantinsulin aspart; insulin degludecinsulin degludecinsulin degludec; liraglutideinsulin detemirinsulin detemir recombinantinsulin glargineinsulin glargineinsulin glargine recombinantinsulin glargine recombinantinsulin glargine-aglrinsulin glargine-yfgninsulin glargine; lixisenatideinsulin glulisine recombinantinsulin humaninsulin humaninsulin humaninsulin human recombinantinsulin lispro protamine recombinant; insulin lispro recombinantinsulin lispro protamine recombinant; insulin lispro recombinantinsulin lispro recombinantinsulin lispro recombinantinsulin lispro recombinantinsulin lispro-aabcinterferon alfa-2binterferon alfa-n3interferon beta-1ainterferon beta-1ainterferon beta-1binterferon beta-1binterferon gamma-1bipilimumabisatuximab-irfcixekizumablanadelumab-flyolaronidaselecanemab-irmbletibotulinumtoxina-wlbglifileucellisocabtagene maraleucellixisenatidelonapegsomatropin-tcgdloncastuximab tesirine-lpyllovotibeglogene autotemcel (lovo-cel)luspatercept-aamtmargetuximab-cmkbmecasermin recombinantmenotropins (FSH;LH)mepolizumabmethoxy polyethylene glycol-epoetin betametreleptinmirikizumab-mrkzmirvetuximab soravtansine-gynxmogamulizumab-kpkcmosunetuzumab-axgbmoxetumomab pasudotox-tdfknadofaragene firadenovec-vncgnatalizumabnatalizumab-sztnnaxitamab-gqgknecitumumabnirsevimab-alipnivolumabnivolumab; 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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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