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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.

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Numerous attorneys have degrees in disciplines such as immunology, biochemistry, molecular biology, biotechnology, biomedical engineering, molecular pharmacology, genetics, biology, and chemistry.

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Potential Impact of the Affordable Prescriptions for Patients Act Patent Limit on BPCIA Litigations
Robert S. Schwartz, Ph.D.
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Prolia® / Xgeva® Biosimilar Updates: Alvotech / Dr. Reddy’s AVT03 aBLA Acceptance, Fresenius Kabi’s Conexxence™ / Bomyntra™ FDA-Approval
Robert S. Schwartz, Ph.D.
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Abecma®AbriladaAccofil®Actemra®Acthrel®Actimmune®Activase® / Cathflo® Activase®Adakveo®AdbryAdcetris®Adlyxin®Admelog® / Admelog SoloStar®Adstiladrin®Aduhelm®Afrezza®Ahzantive®Aimovig®Ajovy®Aldurazyme®Alferon N Injection®Alhemo®AllocordAlymsys®AmjevitaAmphadase®AmtagviAnktiva®Anthim®Apidra® / Apidra SoloSTAR®Aranesp®Arcalyst®Arzerra® / Kesimpta®AsparlasAucatzyl®Avastin®Avonex®Avsola®AVT03AVT05AVT06Avtozma®Avzivi®Basaglar®BAT2206Bavencio®Benlysta®Beovu®BeqvezBesponsa®Besremi®Betaseron®BeyfortusBimzelx®Bizengri®BkemvBlenrep®Blincyto®Bonsity®Botox®Bravelle®Breyanzi®BrineuraBriumviByoovizCablivi®Campath® / Lemtrada®Carvykti®CasgevyCerezyme®Chorionic GonadotropinCimerliCimzia®Cinqair®Clevecord®ColumviConexxence / BomyntraCosentyx®Creon®Crysvita®CT-P42Curosurf®Cyltezo®Cyramza®Danyelza®Darzalex Faspro®Darzalex®Datroway®DaxxifyDenosumab AmnealDraximage® MAADRL_RIDucord®Dupixent®Dysport®EbangaEbglyssEG12014Egrifta®ElahereElaprase®Elelyso®Elevidys®Elfabrio®Elitek®ElrexfioElspar®Elzonris®Emgality®Empliciti®Enbrel®EnceltoEnhertu®EnjaymoEnspryngEntyvio®EnzeevuEpkinlyEpogen® / Procrit®EpysqliErbitux®Erelzi®Erwinaze®Eticovo®Evenity®Evkeeza®Extavia®Eylea®Eylea® HDFabrazyme®Fasenra®Fiasp®FKB238Follistim® AQForteo®Fortical®Fulphila®FylnetraGamifant®Gazyva®Genentech CabillyGenotropin®GintuitGlucaGen®Glucagon®Gonal-f®Gonal-f® RFFGonal-f® RFF Redi-ject®Granix®GrastofilHadlimaHemacord®Hemgenix®Hemlibra®Herceptin Hylecta®Herceptin®HercessiHerzuma®HLX11HLX14HPC, 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®HympavziHyrimoz®Idacio®Ilaris®Ilumya®ImdelltraImfinzi®Imjudo®Imlygic®Imuldosa®Increlex®Infasurf®Inflectra®Inmazeb®Insulin Lispro (Authorized Generic)Insulin-RINTP23Intron AIxifiJeanatope®Jemperli®Jetrea®Jeuveau®Jubbonti® / Wyost®Kadcyla®Kalbitor®Kanjinti®Kanuma®Kebilidi®Kepivance®Kevzara®Keytruda®Kimmtrak®Kineret®KisunlaKrystexxa®Kymriah®Lamzede®LantidraLantus® / Lantus® SoloSTAR®LapelgaLartruvo®LavivLenmeldyLeqembiLetybo®Leukine®Levemir®Levemir® / Levemir® FlexTouch®Libtayo®LoqtorziLucentis®Lumoxiti®LunsumioLusduna NexvueLuxturna®Lyfgenia®LymphirLyumjev®Maci®Margenza®Megatope®Menopur®Mepsevii®Merilog / Merilog SoloStar®Miacalcin®Mircera®Monjuvi®Mvasi®Myalept®MYL-1402O MYL-1601DMylotarg®Myobloc®Myozyme® / Lumizyme®Myxredlin®Naglazyme®Natpara®Nemluvio®Neulasta®Neumega®Neupogen®NexoBrid®Nexviazyme®NgenlaNiktimvoNivestym®Norditropin® FlexProNovarel®NovoLog®Novolog® Mix 70/30Nplate®Nucala®Nulojix®Nutropin AQ®Nutropin®NypoziNyvepria®Ocrevus ZunovoOcrevus®Ogivri®Omisirge®Omlyclo®Omnitrope®OmvohOncaspar®Ontak®Ontruzant®Opdivo QvantigOpdivo®OpdualagOpuvizOrencia®Ospomyv / XbrykOtulfi®Ovidrel®Oxervate®Padcev®Palynziq®Pancreaze®PavbluPegasys®Pegfilgrastim (Lupin)PegIntron® / Sylatron®PelgrazPerjeta®Pertzye®Phesgo®PiaSkyPlegridy®Polivy®PombilitiPortrazza®Poteligeo®Praluent®Praxbind®Pre-Pen®Pregnyl®Proleukin®Prolia® / Xgeva®ProstaScint®Provenge®Pulmotech MAAPulmozyme®Pyzchiva®Qwo®Raxibacumab®Rebif®Reblozyl®RegenecyteRegranex®Releuko®Remicade®Renflexis®ReoPro®Repatha®Retacrit®Retavase®Rethymic®Revcovi®RezvoglarRGB-14RiabniRituxan Hycela®Rituxan®Rixathon®RoctavianRolvedonRuxience®RybrevantRylaze®Ryoncil®Rystiggo®Ryzneuta®Ryzodeg® 70/30 Saizen®Santyl®Saphnelo®Sarclisa®SB8SelarsdiSemglee®Serostim®Siliq®Simlandi®Simponi Aria®Simponi®Simulect®Skyrizi®Skysona®Skytrofa®Sogroya®Soliqua® 100/33Soliris®Somavert®Spevigo®Stelara®SteqeymaStimufend® Stoboclo® / Osenvelt®Stratagraft®Strensiq®Sucraid®Survanta®SusvimoSylvant®SymvessSynagis®Takhzyro®Taltz®TalveyTanzeum®Tecartus®Tecelra®Tecentriq HybrezaTecentriq®TecvayliTepezza®Teriparatide ApotexTeriparatide TevaTevimbra®Tezspire®Thyrogen®Tivdak®TNKase®TofidenceToujeo Solostar®Trazimera®Tremfya®Tresiba®Trodelvy®Trogarzo®Trulicity®Truxima®TVB-009PTX-05Tyenne®Tyruko®Tysabri®TzieldUdenyca®Ultomiris®Unituxin®UnloxcytUplizna®Vabysmo®Vectibix®Vegzelma®VeopozVimizim®Viokace®Vitrase®Voraxaze®VPRIV®Vyepti®Vyjuvek®VyloyVyvgart®Vyvgart® HytruloWezlanaWinrevairWydase®XenpozymeXeomin®Xiaflex®XlucaneXolair®Xultophy® 100/3.6Yervoy®YesafiliYescarta®YesintekYuflyma®YusimryZaltrap®Zarxio®Zenapax®Zenpep®Zevalin®Ziextenzo®Ziihera®Zinplava®Zirabev®Zolgensma®Zomacton®Zorbtive®ZymfentraZynlonta®Zynteglo®Zynyz
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insulin aspart recombinantinsulin aspart recombinantinsulin aspart-szjjinsulin 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-flyolaronidaselebrikizumab-lbkzlecanemab-irmbletibotulinumtoxina-wlbglifileucellisocabtagene maraleucellixisenatidelonapegsomatropin-tcgdloncastuximab tesirine-lpyllovotibeglogene autotemcel (lovo-cel)luspatercept-aamtmargetuximab-cmkbmarstacimab-hncqmecasermin recombinantmenotropins (FSH;LH)mepolizumabmethoxy polyethylene glycol-epoetin betametreleptinmirikizumab-mrkzmirvetuximab soravtansine-gynxmogamulizumab-kpkcmosunetuzumab-axgbmoxetumomab pasudotox-tdfknadofaragene firadenovec-vncgnatalizumabnatalizumab-sztnnaxitamab-gqgknecitumumabnemolizumab-iltonirsevimab-alipnivolumabnivolumab; 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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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