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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.

Venable Team

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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Preliminary Injunction Against Accord’s Simponi® / Simponi Aria® Interchangeable Biosimilars Immgolis™ / Immgolis Intri™
Robert S. Schwartz, Ph.D.
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En Banc Rehearing Denied in Teva v. Eli Lilly, Ajovy® / Emgality® Dispute
Robert S. Schwartz, Ph.D.
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Abecma®ABP 206AbriladaActemra®Acthrel®Actimmune®Activase® / Cathflo® Activase®Adakveo®AdbryAdcetris®ADL-018Adlyxin®Admelog® / Admelog SoloStar®Aduhelm®Afrezza®Ahzantive®Aimovig®Ajovy®Aldurazyme®Alferon N Injection®Alhemo®Alymsys®AmjevitaAmphadase®Anktiva®Anthim®Apidra® / Apidra SoloSTAR®Aranesp®Arcalyst®ArmlupegArzerra® / Kesimpta®AsparlasAvastin®AvlayahAvonex®Avsola®AVT03AVT05AVT06AVT16AVT80Avtozma®Avzivi®Awiqli® FlexTouch®Basaglar®BasalinBavencio®Benlysta®Beovu®Besponsa®Besremi®Betaseron®BeyfortusBildyos® / Bilprevda®Bimzelx®Bizengri®BkemvBlenrep®Blincyto®Bmab 1500Boncresa / OziltusBosaya / AukelsoBotox®BrineuraBriumviByooviz®Cablivi®Campath® / Lemtrada®Cerezyme®Chorionic GonadotropinCimerli®Cimzia®Cinqair®ColumviConexxence / BomyntraCosentyx®Creon®Crysvita®Curosurf®Cyltezo®Cyramza®Danyelza®Darzalex Faspro®Darzalex®Datroway®DaxxifyDecnupazDraximage® MAADRL_ABDupixent®Dysport®EbangaEbglyssEG12014ElahereElaprase®Elfabrio®Elitek®ElrexfioElspar®Elzonris®Emgality®Empliciti®EmrelisEnbrel®EnflonsiaEnhertu®EnjaymoEnnumoEnoby / XtrenboEnspryngEntyvio®ENZ215EnzeevuEpkinlyEpogen® / Procrit®Epysqli®Erbitux®Erelzi®Erwinaze®Eticovo®Evenity®Evkeeza®Exdensur®Extavia®Eydenzelt®Eylea®Eylea® HDFabrazyme®Fasenra®Fiasp®FilkriFKB238Follistim® AQFortical®Fulphila®FylnetraGamifant®GarzulysGazyva®Genotropin®GlucaGen®Glucagon®Gonal-f®Gonal-f® RFFGonal-f® RFF Redi-ject®Granix®GrastofilHadlima®Hemlibra®Hepcludex®Herceptin Hylecta®Herceptin®HercessiHerzuma®HLX04Hulio®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®ImaavyImdelltraImfinzi®Imjudo®Immgolis / Immgolis IntriImuldosa®Increlex®Infasurf®Inflectra®Inmazeb®Insulin Lispro (Authorized Generic)Insulin-RIntron AIsembyldIxifiJeanatope®Jemperli®Jetrea®Jeuveau®JobevneJubbonti® / Wyost®Kadcyla®Kalbitor®Kanjinti®Kanuma®Kepivance®Kevzara®Keytruda QlexKeytruda®Kimmtrak®Kineret®KirstyKisunlaKrystexxa®Lamzede®LanglaraLantus® / Lantus® SoloSTAR®LapelgaLartruvo®Leqembi® [Leqembi Iqlik]Lerochol®Letybo®Leukine®Levemir®Levemir® / Levemir® FlexTouch®Libtayo®Loargys®LoqtorziLucentis®Lumoxiti®LumvoaLunsumioLusduna NexvueLymphirLynozyficLytenavaLyumjev®Margenza®Megatope®Menopur®Mepsevii®Merilog / Merilog SoloStar®Miacalcin®Mircera®Monjuvi®Mvasi®Myalept®Mylotarg®Myobloc®Myozyme® / Lumizyme®Myxredlin®Naglazyme®Natpara®Nemluvio®Neulasta®Neumega®Neupogen®NexoBrid®Nexviazyme®NgenlaNiktimvoNivestym®Norditropin® FlexProNovarel®NovoLog®Novolog® Mix 70/30Nplate®Nucala®NufymcoNulojix®NypoziNyvepria®Ocrevus ZunovoOcrevus®Ogivri®Omlyclo®Omnitrope®OmvohOncaspar®OnswikOntak®Ontruzant®Opdivo QvantigOpdivo®OpdualagOpuviz®Orencia®Ospomyv / XbrykOsvyrti® / Jubereq®Otulfi®Ovidrel®Oxervate®Padcev®Palynziq®Pancreaze®PasatruPavblu®PB016Pegasys®PegIntron® / Sylatron®Penpulimab-kcqxPerjeta®Pertzye®Phesgo®PiaSkyPlegridy®Poherdy®Polivy®PombilitiPonlimsi / DegevmaPortrazza®Poteligeo®Praluent®PrandilinPraxbind®Pre-Pen®Pregnyl®Proleukin®Prolia® / Xgeva®ProstaScint®Pulmotech MAAPulmozyme®Pyzchiva®Qwo®RanluspecRapilinRaxibacumab®Rebif®Reblozyl®Regranex®Releuko®Remicade®Renflexis®ReoPro®Repatha®Retacrit®Retavase®Revcovi®RezvoglarRiabniRituxan Hycela®Rituxan®Rixathon®RolvedonRuxience®RybrevantRylaze®Rystiggo®Ryzneuta®Ryzodeg® 70/30 Santyl®Saphnelo®Sarclisa® / Sarclisa EscenaSB8SCD-411SelarsdiSemglee®Siliq®Simlandi®Simponi Aria®Simponi®Simulect®Skyrizi®Skytrofa®Sogroya®Soliqua® 100/33Soliris®Somavert®Spevigo®Starjemza®Stelara®SteqeymaStimufend® Stoboclo® / Osenvelt®Strensiq®Sucraid®Survanta®SusvimoSylvant®Synagis®Takhzyro®Taltz®TalveyTanzeum®Tecentriq HybrezaTecentriq®TecvayliTepezza®TEV-45779Tevimbra®Tezspire®Tivdak®TNKase®TofidenceToujeo Solostar®Trazimera®Tremfya®Tresiba®Trodelvy®Trogarzo®Trulicity®TrutaknaTruxima®TX-05Tyenne®Tyruko®Tysabri®TzieldUdenyca®Ultomiris®Unituxin®UnloxcytUplizna®Vabysmo®Vectibix®Vegzelma®VeopozVimizim®Viokace®Vitrase®Voraxaze®Voyxact®Vyepti®VyloyVyvgart®Vyvgart® HytruloWezlanaWinrevairWydase®XenpozymeXeomin®Xiaflex®XlucaneXolair®Xultophy® 100/3.6Yartemlea®Yervoy®Yesafili®YesintekYuflyma®Yusimry®Zaltrap®Zarxio®Zenapax®Zenpep®Zevalin®Ziextenzo®Ziihera®ZimrixbyZinplava®Zirabev®ZymfentraZynlonta®Zynyz
abataceptabataceptabataceptabciximababobotulinumtoxinAadalimumabadalimumab-aacfadalimumab-aatyadalimumab-adazadalimumab-adbmadalimumab-afzbadalimumab-aqvhadalimumab-attoadalimumab-bwwdadalimumab-fkjpadalimumab-ryvkado-trastuzumab emtansineaducanumab-avwaafliberceptafliberceptafliberceptafliberceptaflibercept-abzvaflibercept-ayyhaflibercept-boavaflibercept-jbvfaflibercept-mrbbaflibercept-yszyagalsidase betaalbiglutidealbumin iodinated I-125 serumalbumin iodinated I-131 serumaldesleukinalemtuzumabalglucosidase alfaalirocumabalteplaseamivantamab-vmjwanacaulase-bcdbanakinraanifrolumab-fniaansuvimab-zyklapitegromab-mstnasfotase alfaasparaginaseasparaginase erwinia chrysanthemiasparaginase erwinia chrysanthemi (recombinant)-rywnataciept-vymjatezolizumabatezolizumab and hyaluronidase-tqjsatoltivimab; odesivimab; maftivimabavalglucosidase alfa-ngptavelumabaxatilimab-csfrbasiliximabbecaplerminbelantamab mafodotin-blmfbelataceptbelimumabbenralizumabbenzylpenicilloyl polylysineberactantbevacizumabbevacizumabbevacizumabbevacizumabbevacizumab-adcdbevacizumab-awwbbevacizumab-bvzrbevacizumab-malybevacizumab-nwgdbevacizumab-tnjnbevacizumab-vikgbezlotoxumabbimekizumab-bkzxblinatumomabbrentuximab vedotinbrodalumabbrolucizumab-dbllbulevirtide-gmodburosumab-twzacalaspargase pegol-mknlcalcitonin salmoncalcitonin salmoncalfactantcanakinumabcaplacizumab-yhdpcapromab pendetidecemiplimab-rwlccenegermin-bkbjcerliponase alfacertolizumab pegolcetuximabchorigonadotropin alfachorionic gonadotropinchorionic gonadotropinchorionic gonadotropincipaglucosidase alfa-atgaclerovimab-cforcollagenasecollagenase clostridium histolyticumcollagenase clostridium histolyticum-aaesconcizumab-mtcicorticorelin ovine triflutatecosibelimab-ipdlcrizanlizumab-tmcacrovalimab-akkzdaclizumabdaratumumabdaratumumab; hyaluronidase-fihjdarbepoetin alfadatopotamab deruxtecan-dlnkdaxibotulinumtoixnA-lanmdenileukin diftitoxdenileukin diftitox-cxdldenosumabdenosumabdenosumabdenosumab-adetdenosumab-bbdzdenosumab-bmwodenosumab-bnhtdenosumab-desudenosumab-dssbdenosumab-kyqqdenosumab-mobzdenosumab-nxxpdenosumab-qbdedepemokimab-ulaadinutuximabdonanemab-azbtdornase alfadostarlimab-gxlydulaglutidedupilumabdurvalumabecallantideeculizumabeculizumab-aagheculizumab-aeebefbemalenograstim-alfa-vuxwefgartigimod alfa and hyaluronidase-qvfcefgartigimod alfa-fcabeflapegrastim-xnstelapegademase-lvlrelosulfase alfaelotuzumabelranatamabemapalumab-lzsgemicizumab-kxwhenfortumab vedotin-ejfvepcoritamab-byspepoetin alfaepoetin alfa-epbxeptinezumab-jjmrerenumab-aooeetanerceptetanercept-szzsetanercept-ykroevinacumab-dgnbevolocumabfam-trastuzumab deruxtecan-nxkifaricimab-svoafilgrastimfilgrastimfilgrastim-aafifilgrastim-ayowfilgrastim-lahafilgrastim-sndzfilgrastim-txidfollitropin alfa/betafollitropin alfa/betafollitropin alfa/betafollitropin alfa/betafremanezumab-vfrmgalcanezumab-gnlmgalsulfasegaretosmab-grtsgemtuzumab ozogamicinglofitamab-gxbmglucagonglucagonglucarpidasegolimumabgolimumabgolimumabgolimumab-sldiguselkumabhyaluronidasehyaluronidasehyaluronidasehyaluronidasehyaluronidaseibalizumab-uiykibritumomab tiuxetanidarucizumabidecabtagene vicleucelidursulfaseimigluceraseincobotulinumtoxinAinebilizumabinfliximabinfliximab-abdainfliximab-axxqInfliximab-dyybInfliximab-dyyb (for subcutanous use)infliximab-qbtxinotuzumab ozogamicininsulin aspartinsulin aspartinsulin aspart protamine recombinant; insulin aspart recombinantinsulin aspart recombinantinsulin aspart-fsaninsulin aspart-szjjinsulin aspart-xjhzinsulin aspart; insulin degludecinsulin degludecinsulin degludec; liraglutideinsulin detemirinsulin detemir recombinantinsulin efsitora alfa-gobeinsulin glargineinsulin glargineinsulin glargineinsulin glargine recombinantinsulin glargine recombinantinsulin glargine-aglrinsulin glargine-aldyinsulin glargine-yfgninsulin glargine; lixisenatideinsulin glulisine recombinantinsulin humaninsulin humaninsulin humaninsulin human recombinantinsulin lisproinsulin lispro protamine recombinant; insulin lispro recombinantinsulin lispro protamine recombinant; insulin lispro recombinantinsulin lispro recombinantinsulin lispro recombinantinsulin lispro recombinantinsulin lispro-aabcinsulinn icodec-abaeinterferon alfa-2binterferon alfa-n3interferon beta-1ainterferon beta-1ainterferon beta-1binterferon beta-1binterferon gamma-1bipilimumabisatuximab-irfcixekizumablanadelumab-flyolaronidaselebrikizumab-lbkzlecanemab-irmblerodalcibep-ligaletibotulinumtoxina-wlbglinvoseltamab-gcptlixisenatidelonapegsomatropin-tcgdloncastuximab tesirine-lpylluspatercept-aamtmargetuximab-cmkbmarstacimab-hncqmecasermin recombinantmenotropins (FSH;LH)mepolizumabmethoxy polyethylene glycol-epoetin betametreleptinmirikizumab-mrkzmirvetuximab soravtansine-gynxmogamulizumab-kpkcmosunetuzumab-axgbmoxetumomab pasudotox-tdfknarsoplimab-wuugnatalizumabnatalizumab-sztnnaxitamab-gqgknecitumumabnemolizumab-iltonipocalimab-aahunirsevimab-alipnivolumabnivolumabnivolumab; elatlimab-rmbwnivolumab; hyaluronidase-nvhynogapendekin alfa inbakicept-pmlnobiltoxaximabobinutuzumabocrelizumabocrelizumab; hyaluronidase-ocsqocriplasminofatumumabolaratumabolipudase alfa-rpcpomalizumabomalizumabomalizumabomalizumab-igeconabotulinumtoxinAoprelvekinpaliferminpalivizumabpancrelipase (amylase; lipase; protease)pancrelipase (amylase; lipase; protease)pancrelipase (amylase; lipase; protease)pancrelipase (amylase; lipase; protease)pancrelipase (amylase; lipase; protease)panitumumabparathyroid hormonepegaspargasepegfilgrastimpegfilgrastimpegfilgrastim-apgfpegfilgrastim-bmezpegfilgrastim-cbqvpegfilgrastim-fpgkpegfilgrastim-jmdbpegfilgrastim-pbbkpegfilgrastim-pccgpegfilgrastim-unnepeginterferon alfa-2apeginterferon alfa-2bpeginterferon beta-1apegloticasepegunigalsidase alfa-iwxjpegvaliase-pqpzpegvisomantpegzilarginase-nblnpembrolizumabpembrolizumab; berahyaluronidase alfa-pmphpenpulimab-kcqxpertuzumabpertuzumabpertuzumab-dpzbpertuzumab; trastuzumab; hyaluronidase-zzxfpivekimab sunirine-pvzypolatuzumab vedotin-piiqporactant alfapozelimab-bbfgprabotulinumtoxinA-xvfsramucirumabranibizumabranibizumabranibizumab injectionranibizumab-eqrnranibizumab-hkdzranibizumab-leykranibizumab-nunarasburicaseravulizumab-cwvzraxibacumabreslizumabreteplaseretifanlimab-dlwrrilonaceptrimabotulinumtoxinBrisankizumab-rzaarituximabrituximabrituximab-abbsrituximab-arrxrituximab-cdxxrituximab-pvvrrituximab; hyaluronidaseromiplostimromosozumab-aqqgropeginterferon alfa-2b-njftrozanolixizumab-nolisacituzumab govitecan-hziysacrosidasesargramostimsarilumabsatralizumabsebelipase alfasecukinumabsibeprenlimab-szsisiltuximabsomapacitan-becosomatrogon-ghlasomatropinsomatropinsomatropinsomatropinsotatercept-csrkspesolimab-sbzosutimlimab-jometafasitamab-cxixtagraxofusp-erzstalquetamab-tgvstarlatamab-dlletbo-filgrastimtebentafusp-tebntechnetium Tc 99m albumin aggregatedtechnetium Tc 99m albumin aggregated kitteclistamab-cqyvtelisotuzumab vedotin-tllvtenecteplaseteplizumab-mzwvteprotumumab-trbwtezepelumab-ekkotildrakizumab-asmntislelizumab-jsgrtisotumab vedotin-tftvtividenofusp alfa-eknmtocilizumabtocilizumab-aazgtocilizumab-anohtocilizumab-bavitoripalimab-tpzitralokinumab-ldrmtrastuzumabtrastuzumabtrastuzumabtrastuzumab-annstrastuzumab-dksttrastuzumab-dttbtrastuzumab-pkrbtrastuzumab-qyyptrastuzumab-strftrastuzumab; hyaluronidase-oysktremelimumab-actlublituximabustekinumabustekinumab-aauzustekinumab-aeknustekinumab-auubustekinumab-hmnyustekinumab-kfceustekinumab-srlfustekinumab-stbaustekinumab-ttwevedolizumabvedolizumabvedolizumab (intravenous)vedolizumab (subcutaneous)veligrotug-vvzevelmanase alfa-tycvvestronidase alfa-vjbkzanidatamab-hriizenocutuzumab-zbcoziv-aflibercept
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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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