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hyaluronidase-fihjdarbepoetin alfadaxibotulinumtoixnA-lanmdelandistrogene moxeparvovec-rokldenileukin diftitoxdenileukin diftitox-cxdldenosumabdenosumabdenosumabdenosumabdenosumabdenosumabdenosumabdenosumabdenosumab-bbdzdinutuximabdonanemab-azbtdonislecel-jujndornase alfadostarlimab-gxlydulaglutidedupilumabdurvalumabecallantideeculizumabeculizumab-aagheculizumab-aeebefbemalenograstim-alfa-vuxwefgartigimod alfa and hyaluronidase-qvfcefgartigimod alfa-fcabeflapegrastim-xnsteladocagene exuparvovec-tneqelapegademase-lvlrelivaldogene autotemcelelosulfase alfaelotuzumabelranatamabemapalumab-lzsgemicizumab-kxwhenfortumab vedotin-ejfvepcoritamab-byspepoetin alfaepoetin alfa-epbxeptinezumab-jjmrerenumab-aooeetanerceptetanercept-szzsetanercept-ykroetranacogene dezaparvovec-drlbevinacumab-dgnbevolocumabexagamglogene Autotemcel (exa-cel)fam-trastuzumab deruxtecan-nxkifaricimab-svoafidanacogene elaparvovec-dzktfilgrastimfilgrastimfilgrastimfilgrastim-aafifilgrastim-ayowfilgrastim-sndzfilgrastim-txidfollitropin alfa/betafollitropin alfa/betafollitropin alfa/betafollitropin alfa/betafremanezumab-vfrmgalcanezumab-gnlmgalsulfasegemtuzumab ozogamicinglofitamab-gxbmglucagonglucagonglucarpidasegolimumabgolimumabguselkumabHPC, Cord BloodHPC, Cord BloodHPC, Cord BloodHPC, Cord BloodHPC, Cord BloodHPC, Cord BloodHPC, Cord BloodHPC, Cord BloodHPC, Cord Bloodhyaluronidasehyaluronidasehyaluronidasehyaluronidasehyaluronidaseibalizumab-uiykibritumomab tiuxetanidarucizumabidecabtagene vicleucelidecabtagene vicleucelidursulfaseimigluceraseincobotulinumtoxinAinebilizumabinfliximabinfliximab-abdainfliximab-axxqInfliximab-dyybInfliximab-dyyb (for subcutanous use)infliximab-qbtxinotuzumab ozogamicininsulin aspartinsulin aspartinsulin aspart protamine recombinant; 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-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; elatlimab-rmbwnogapendekin alfa inbakicept-pmlnobecabtagene autoleucelobiltoxaximabobinutuzumabocrelizumabocrelizumab; hyaluronidase-ocsqocriplasminofatumumabolaratumabolipudase alfa-rpcpomalizumabomalizumabomidubicel-onlvonabotulinumtoxinAonasemnogene abeparvovec-xioioprelvekinpaliferminpalivizumabpancrelipase (amylase; lipase; protease)pancrelipase (amylase; lipase; protease)pancrelipase (amylase; lipase; protease)pancrelipase (amylase; lipase; protease)pancrelipase (amylase; lipase; protease)panitumumabparathyroid hormonepegaspargasepegfilgrastimpegfilgrastimpegfilgrastimpegfilgrastimpegfilgrastim-apgfpegfilgrastim-bmezpegfilgrastim-cbqvpegfilgrastim-fpgkpegfilgrastim-jmdbpegfilgrastim-pbbkpeginterferon alfa-2apeginterferon alfa-2bpeginterferon beta-1apegloticasepegunigalsidase alfa-iwxjpegvaliase-pqpzpegvisomantpembrolizumabpertuzumabpertuzumab; trastuzumab; hyaluronidase-zzxfpolatuzumab vedotin-piiqporactant alfapozelimab-bbfgprabotulinumtoxinA-xvfsramucirumabranibizumabranibizumabranibizumab-eqrnranibizumab-nunaranobizumabrasburicaseravulizumab-cwvzraxibacumabreslizumabreteplaseretifanlimab-dlwrrilonaceptrimabotulinumtoxinBrisankizumab-rzaarituximabrituximabrituximabrituximab-abbsrituximab-arrxrituximab-pvvrrituximab; hyaluronidaseromiplostimromosozumab-aqqgropeginterferon alfa-2b-njftrozanolixizumab-nolisacituzumab govitecan-hziysacrosidasesargramostimsarilumabsatralizumabsebelipase alfasecukinumabsiltuximabsipuleucel-Tsomapacitan-becosomatrogon-ghlasomatropinsomatropinsomatropinsomatropinsomatropinsomatropinsomatropinsomatropinsomatropin (rDNA origin)somatropin recombinantsotatercept-csrkspesolimab-sbzosutimlimab-jometafasitamab-cxixtagraxofusp-erzstaliglucerase alfatalimogene laherparepvectalquetamab-tgvstarlatamab-dlletbo-filgrastimtebentafusp-tebntechnetium Tc 99m albumin aggregatedtechnetium Tc 99m albumin aggregated kitteclistamab-cqyvtenecteplaseteplizumab-mzwvteprotumumab-trbwteriparatideteriparatideteriparatideteriparatidetesamorelin acetatetezepelumab-ekkothyrotropin alfatildrakizumab-asmntisagenlecleuceltislelizumabtisotumab vedotin-tftvtocilizumabtocilizumabtocilizumab-aazgtocilizumab-bavitoripalimab-tpzitralokinumab-ldrmtrastuzumabtrastuzumabtrastuzumabtrastuzumab-annstrastuzumab-dksttrastuzumab-dttbtrastuzumab-pkrbtrastuzumab-qyyptrastuzumab-strftrastuzumab; 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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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