Document byvXdV6NMgKeZqaYY6V5J8916

PFAS STOPPER ADVOCACY SUPPORTIVE STATEMENTS Statement#2: There are approximately 200+ marketed biologic drugs1 in prefilled syringes sold by 250+ different organizations** across Europe. We estimate that most of these drugs (in prefilled syringes), due to their sensitive nature, use a PFAS coated stopper. Examples of indications of these drugs include but are not limited to multiple sclerosis, rheumatoid arthritis, and neutropenia. Source/Reference: 1. Biologic injectable drugs are defined in IQVIA* (https://www.iqvia.com/) Smart MIDAS 2022 report (downloaded on June 7th, 2023) according to the nature of the drug (eg. biologics/large molecules), type of container (eg. prefilled syringe, autoinjector), therapeutic indication (ATC), and drug geography *Based on our understanding on IQVIA's data acquisition methodology for the data referenced in this document, IQVIA tracks data at multiple points of the pharmaceutical distribution system. IQVIA acquires data based on the pharmaceutical drug reported at the final point of use (for eg. pharmacy, hospitals). Data is also acquired via entities such as distributors, wholesalers, and pharmaceutical companies who sell directly to hospitals, pharmacies, clinics etc. IQVIA seems to diligently align with international data protection practices as referenced in the following link: https://www.iqvia.com/about-us/privacy/gdpr-at-iqvia **Organizations include but are not limited to pharmaceutical companies, their subsidiaries/regional offices, and distributors selling biologics across Europe Substantiation: IQVIA sales of injectable drugs in prefilled syringes and/or auto injectors is filtered by the following criteria: nature of the drug (small molecules, biologics/large molecules), route of administration (intravenous, subcutaneous, intramuscular), and frequency of treatment The following list (downloaded on June 7th, 2023) of biologic drugs has been downloaded from the IQVIA database representing drugs sold in prefilled syringes and/or autoinjectors by pharmaceutical companies across Europe. Product TRULICITY COPAXONE HUMIRA BENEPALI ZARZIO Standard Units 2020 36,828,666 9,456,380 6,002,469 3,953,467 3,746,510 Standard Units 2021 47,695,738 8,890,996 5,504,068 4,235,004 3,733,434 Standard Units 2022 64,594,228 7,850,172 5,174,598 4,253,584 4,240,397 PFAS STOPPER ADVOCACY SUPPORTIVE STATEMENTS ENBREL TIMEXON PROLIA XOLAIR NEUKINE AMGEVITA ACTEMRA HYRIMOZ REPATHA KINERET GENOTROPIN DUPIXENT ERELZI IMRALDI COSENTYX REBIF NIVESTIM ZOLADEX ORENCIA CIMZIA PRALUENT AVONEX FRAVEN ORGALUTRAN OVITRELLE BYDUREON CLIFT VTRS TEBERIF DECAPEPTYL SIMPONI IDACIO ENANTONE HULIO FYREMADEL INTERFER B 1B BICR STELARA LEUCOSTIM AIMOVIG TALTZ PEGASYS ENTYVIO PLEGRIDY REMSIMA 4,913,724 3,562,384 2,625,248 2,553,180 2,312,742 1,902,779 2,225,744 1,205,143 1,417,246 2,020,091 2,634,706 716,242 1,115,175 1,606,406 1,755,339 2,861,255 1,665,154 1,397,923 1,439,275 1,359,465 762,074 1,556,343 682,758 880,068 944,743 488,623 987,055 60,033 679,024 903,953 91,890 832,222 424,206 607,652 677,445 500,462 584,538 400,284 371,151 432,084 48,869 478,532 26,007 4,524,437 3,425,426 2,906,103 2,918,552 2,541,254 2,406,027 2,377,203 2,006,538 1,881,345 2,582,601 2,338,114 1,319,919 1,394,131 1,857,068 1,846,524 2,161,694 1,755,780 1,422,735 1,495,209 1,497,720 1,065,469 1,443,279 746,767 1,156,276 1,220,081 1,204,507 875,294 668,946 981,453 945,161 405,914 843,810 650,324 770,719 571,435 617,009 775,929 502,677 498,513 517,344 288,548 530,544 199,668 3,714,261 3,610,554 3,286,656 3,133,499 2,931,739 2,778,424 2,584,737 2,557,202 2,502,452 2,454,640 2,352,518 2,027,400 2,011,239 2,001,788 1,727,289 1,711,740 1,656,108 1,587,762 1,556,135 1,545,415 1,501,937 1,336,206 1,300,617 1,252,559 1,199,722 1,127,921 1,040,655 1,038,183 1,024,451 969,503 893,862 870,435 787,323 751,246 747,650 745,436 655,522 651,442 622,793 610,389 599,394 582,039 558,174 PFAS STOPPER ADVOCACY SUPPORTIVE STATEMENTS NEUPOGEN SOMATULINE AJOVY NUCALA FILGRASTIM NOVT LUPRON EMGALITY ILSIRA BENLYSTA TREMFYA KEVZARA ELIGARD NEUPEG FILGRASTIM L.U. TYSABRI NEULASTA RESELIGO KYNTHEUM GRASALVA GLATIRAMER AC VTRS SKYRIZI FASENRA ZIEXTENZO SIROCTID REMUREL LECTRUM RATIOGRASTIM DEPO-ELIGARD PELMEG YUFLYMA KESIMPTA GLATIRATE LONQUEX EFLEIRA OCTREOTID-HAMELN NEPEXTO ADTRALZA EVENITY NEUTROGIN GOSERELIN-LONG LEUPRORELIN NOVT CARBETOCIN AGUE SUPREFACT 809,855 410,154 73,005 176,659 411,069 289,951 71,611 31,936 182,465 121,531 189,520 305,737 163,178 106,880 365,791 225,051 130,007 498,834 172,001 61,989 115,213 100,356 215,456 215,800 136,995 129,036 129,611 120,175 111,216 140,287 32,274 83,915 4,612 6,158 24,783 8,638 46,943 42,909 66,952 864,789 449,983 245,300 301,463 397,624 374,190 194,338 572,546 247,473 188,685 282,327 270,238 227,311 219,260 32,633 316,154 238,375 188,944 373,360 223,603 147,240 160,319 148,844 207,208 195,553 140,912 122,675 122,864 131,801 5,658 7,901 174,496 121,369 102,892 97,646 42,806 11,667 32,077 86,610 79,608 47,261 56,530 65,441 490,760 468,781 440,467 392,338 383,766 360,275 337,890 335,238 320,631 290,791 285,571 281,642 268,027 267,565 260,185 253,715 239,892 229,443 223,566 217,228 207,209 202,953 183,552 180,513 166,343 137,211 127,255 124,621 123,612 122,134 113,708 112,980 112,795 109,478 101,915 94,201 88,757 87,529 86,778 79,637 62,938 61,519 60,802 PFAS STOPPER ADVOCACY SUPPORTIVE STATEMENTS ETANERCEPT PSK ILUMETRI GONAL-F PALYNZIQ FILGRASTIM TEVA BINNOFERON FULPHILA BEMFOLA DALIBRA OCTREOTIDE L.U. TRIPTOFEM SINNOMER OCTREOTIDE KET INSULIN SOLUBLE UM XANDERLA EXTIMIA MYRELEZ ENANTON DEPOT GLATIRAMER AC L.U. TREOJECT LEUPRORELIN TEVA BIMZELX PERSCLERAN LEQVIO GRASUSTEK LIBREXA SYNVISC ELONVA RECIGEN GLATIRAMER AC TEVA NYVEPRIA BEVACIZUMAB L.U. GLUCAGON NOVN GANIRELIX THRX GANIRELIX ORIF LEUPRO-SAND. BBF CEGFILA LEUGON XILBRILADA CARBETOCINA GP-PHA HUKYNDRA ALTEBREL ORGALUTRAN AB8 17,363 54,768 13,788 40,841 678 4,846 28,440 43,346 42,925 39,818 41,225 25,507 23,261 14,679 29,415 23,120 58,951 25,332 30,532 6,909 20,803 23,766 170,328 11,311 14,932 8,204 927 1,910 8,857 2,736 34,297 41,994 28,328 42,975 53,808 25,189 36,060 40,254 44,837 47,646 43,210 39,663 25,082 20,727 70 33,628 27,880 37,401 26,368 1,330 28,860 4,647 17,781 3,566 19,761 26,372 75,124 8,075 14,089 13,899 9,088 6,400 6,735 733 9,773 60,436 56,720 54,566 50,945 49,610 46,548 44,171 43,918 42,620 41,663 41,422 40,428 38,575 38,090 37,976 35,041 33,252 32,332 27,012 26,219 25,594 25,545 24,778 24,130 23,731 22,761 21,859 21,833 21,468 20,674 18,978 17,545 17,512 17,250 16,031 15,668 14,180 13,541 13,397 12,083 12,035 10,856 10,035 PFAS STOPPER ADVOCACY SUPPORTIVE STATEMENTS GANIRELIX GEDN GLACETAT GLUCAGEN TEGSEDI WEGOVY LEPTOPROL INALFAB GLATIRAMYL ALGERON ATOSIBAN INTB OXYTOCIN L.U. ADALIRA EXEMPTIA GANIRAN ASTARTE MYTOLAC ADZ LEUPROR.SAND.MTK GANIRELIX-ASTRO LEUPRORELIN M7M LEUPRORELIN PHARMA ETANERCEPT L.U. POEXO LEUPRORELIN ORI PELGRAZ DEPLANDA MYTOLAC-AD+ MIACALCIC VEBLOCEMA WAYLIVRA LEUPRORELIN PAR ACCOFIL EBB TEZSPIRE ADALIMAB TETRIDAR LUCRIN ROFERON-A ENSPRYNG LEUPRORELIN ABAC PEGFILGRASTIM L.U. LEUPRO-SAND. EUP LEUPRO-SAND. ORI LEUPROLIDE NOVT 26,992 6,499 7,923 9,484 5,259 4,244 28,816 692 3,857 1,923 2,652 2,576 5,161 312 81,725 599 510 348 40 1,771 282,245 7 17 3,833 50,120 6,779 8,532 9,416 8,553 6,976 10,680 3,058 3,167 414 2,450 5,038 2,256 100 6,328 1,225 59,725 1,154 654 160 1,294 495 1,405 9,330 239 821 737 2,820 9,219 7,756 7,537 7,048 6,587 6,429 5,801 5,776 5,573 5,238 4,293 4,150 4,124 3,926 3,908 3,694 3,602 3,375 2,584 2,574 2,496 2,413 2,132 1,710 1,650 1,606 1,583 1,459 1,377 1,311 1,300 1,249 1,194 1,176 1,048 981 909 851 805 751 614 599 PFAS STOPPER ADVOCACY SUPPORTIVE STATEMENTS STALADEX OMALIZUMAB L.U. STIMUFEND FILGRASTIM NANOLEK LEUPRO-SAND. AB8 LEUPRORE-SAN.EUG GOSERELIN L.U. LEUPROREL SA PAR OGLUO AMVUTTRA CLIFT NEULASTIM PEGFILGRASTIM ALTEVIR LANREOTIDE L.U. GRANULOKINE PEPTYS 2 LEUPRORELIN-OF-B+O LEUPRONE HEX.CC4 ZOMACTON GONAPEP.DEP-OF-B+O PEGSTIM CINNORA GONAPEP.DEP-OF-FSF GRASTOFIL LEUPRORELIN EBB GENFAXON Grand Total 1 22 1,708 63 3,231 2,329 6,170 8 32 400 7,517 155 66 122,551,251 272 16 69 84 109 860 295 2,385 1,221 7,160 13 195 7 141,830,259 266 258 255 243 169 83 77 72 51 43 36 23 20 13 11 10 9 5 2 -1 165,205,288 The following list (downloaded on June 7th, 2023) has been downloaded from the IQVIA database representing entities (including authorized/registered/licensed pharmaceutical companies, their subsidiaries/regional offices, and distributors) selling biologic drugs in prefilled syringes and/or autoinjectors across Europe. For the purposes of the analysis, the `remove duplicates' option has been used in excel to ensure an entity is not counted multiple times. In addition, manual deletion has been done to confirm duplicates have been removed. LILLY FRANCE LILLY SAE LILLY PORTUGAL PARANOVA LILLY NEDERLAND SAMSUNG BIOEPIS BIOGEN FRANCE BIOGEN ITALIA BIOGEN IDEC BIOGEN EWO ABBVIE AB RECORDATI BOUCHARA RECORDATI JABA RECORDATI HERBACOS PFAS STOPPER ADVOCACY SUPPORTIVE STATEMENTS ABACUS MEDICINE MEDARTUUM BROCACEF ELI LILLY NORGE AS 2CARE4 APS STEPHAR MEDCOR BMODESTO EBB MEDICAL AB ORIFARM ORIGINALIS B.V. EU-PHARMA PHARMACHIM FISHER FARMA TEVA UK TEVA ITALIA RATIOPHARM TEVA PHARM.BELGIUM PLIVA MEPHA-TEVA KOHLPHARMA EURIM-PHARM TEVA/RATIOPHARM AXICORP PHA.B.V. EMRA-MED DOCPHARM ORIFARM LEVERKUS TEVA NEDERLAND ORIGINALIS ELVIM HAEMATO-PHARM MEDICOPHARM 101 CAREFARM EUROPEAN PHARMA BB FARMA ABBVIE GMBH ABBVIE AG CC PHARMA NMG PHARMA AXICORP PHARMA PB PHARMA ACA MUELLER SYNCO PHARMA BIOGEN SWITZERLAND EWOPHARMA ADEQUAPHARM AARAGON PHARMA SANDOZ FARMACEUTIC SANDOZ GMBH INOPHA LEK HAEMATO PHARM SANDOZ PHARMA AS PFIZER-PHARMA WYETH PHARM. PFIZER EUROPE WYETH BIOCAD RF AMGEN GMBH AMGEN B.V. AMGEN EUROPE BV MPA AMGEN - BIOFARMACE AMICUS PHARMASWISS 14U PHARMA NOVARTIS PHARM UK NOVARTIS EUROPH ACCORD HEALTHCARE ROCHE AUSTRIA ROCHE PHARMA SCHWE ROCHE REG LTD ROCHE HUNGARY ROCHE FARM.QUIMICA ROCHE NORGE AS HEXAL SWEDISH ORPHAN BIOVITRUM SOBI SWEDISH ORPHAN BIO ORPHAN SANOFI SANOFI WINTHROP SANOFI BELGIUM SANOFI-SYNTHELABO SWIXX BIOPHARMA ASTELLAS PHARMA RECORDATI SPA RECORDATI IND CH F MEDIGENE TOLMAR CORP.PANAMA INOPHA I1P ZENTIVA ALVOGEN LABORMED TRADING PHARMAMAX LEO FARMACEUTICOS LEO PHARMA A/S MYLAN BV ABBVIE DEUTCHLAND ALFASIGMA PHARMANOVIA IBISQUS AOP ORPHAN PHARM. ROWEX RATIOPHARM GMBH CASEN RECORDATI MUNDIPHARMA SAS NAPP EGIS CINFA BIOTECH NOVARTIS PHAR.VERT NOVARTIS IRELAND NOVARTIS FINLAND R-PHARM ZAO RF ISTITUTO GENTILI UAB SICOR BIOTECH NATIVITA BELARUS HAMELN PHARMA MYLAN IRE HEALTHCA U.C.B.FARMA NED.BV CHUGAI PHARMA UFAVITA RF SANDOZ A/S AGUETTANT ITALIA AVENTIS EUROCEPT CHEPLAPHARM ARZNEI AVAS PHARMACEUTIC. PFAS STOPPER ADVOCACY SUPPORTIVE STATEMENTS FD PHARMA CANOMA PHARMA MERCK SERONO UK MERCK EUROPE MERCK BV HOSPIRA UK ABACUS PFIZER BV ORNA CARECEPT HOSPIRA PORTUGAL ASTRAZENECA ZENECA PHARMA POLYFARMA BV ADL PHARMA CROSS PHARMA PI-PHARMA BMS PHARMA EEI UCB DEUTSCHLAND UCB PHARMA SA MEDA AB SANOFI-AVENTIS GRO SANOFI SYNTHELABO GEN ILAC BIOGEN NETHERLA.BV BIOGEN IDEC LTD ARVEN ORGANON SALUD ORGANON FRANCE ORGANON PORTUGUESA NV ORGANON ORGANON FINLAND MERCK SHARP DOHME GERKE PHARMA MERCK KFT MYLAN VIATRIS HEAL.B. MYLAN UK HLTHCARE GERARD MYLAN AB FERRING PHARMACEUT FERRING LEGEMID.AS FERRING B.V. NOVARTIS EUROPHARM SCHERING PLOUGH MERCK SHARP DOH/SP JANSSEN CILAG ABACUS MEDICINE FRESENIUS KABI DE FRESENIUS KABI FR. FRESENIUS KABI AUS MEDIAS INT. TAKEDA ITALIA FARM TAKEDA PHARMA VIATRIS MEDICAL MYLAN EPD MYLAN IRE HC LTD. MYLAN SAS RANBAXY UK SUN PHARM IND EURO SUN PHARMACEUTICAL JANSSEN-CILAG S.A. JANSSEN-CILAG PH JANSSEN-CIL INT JOHNSON & JOHNSON JANSSEN/CILAG FAR. DEM ILAC CHEPLAPHARM ABDI IBRAHIM ALLOGA ITALIA ROVI CPS CITO PHARMA ZR PHARMA & GMBH PHARMAAND LOBA FREINCH TAKEDA S.A. TAKEDA PHARM AS TAKEDA AS GEN ILAC VE SAGLIK CELLTRION HC UK LT KERN PHARMA PHARMAKERN ASTRO-PHARMA GMBH OKTAL PHARMA MTK PHARMA BEAUFOUR IPSEN RUBIO PSK PHARMA ALMIRALL HERMAL ALMIRALL S.A. ALMIRALL PHARM ALMIRALL PROD. BIOMARIN INTERNAT. BIOMARIN PHARMAC BINNOPHARM RF VIATRIS LIMITED GEDEON RICHTER D.C.I. MARCKYRL PHARMA CINNAGEN CO KENT PHARM CORREVIO AMDIPHARM ADVANZ PHARMA ITAL ORION PHARMA CC PHARMA NORD ITALFARMACO G.L.PHARMA GMBH JUTA PHARMA MEDAC IQONE HEALTHCARE ZENTIVA FRANCE LEK-AM BIOMATRIX B2B MEDICAL GENZYME ACTIPART AVITAMED BIOS MEDIZINPR. +ACTIC MEDICAL 1001 ARTIKEL MEDIC ROEMER-PHARMA ABZ PHARMA THERAMEX IRELAND BIOGARAN STADA ENDOMEDICA GP-PHARM STADA ARZNEIM PFAS STOPPER ADVOCACY SUPPORTIVE STATEMENTS FERRING LECIVA FERRING PORTUGUESA MEDISOURCE MSD FRANCE MSD SHARP&DOHME MSD MERCK/SHRP/DOH JANSSEN BIOLOGICS JANSSEN-CILAG MSD BELGIUM IPSEN PHARMA SA IPSEN POLAND FUTURE HEALTH PH IPSEN SCANDINAVIA EURECO PHARM GLAXOSMITHKLINE PH GLAXOSMITH TRAD BERLIN-CH/MENARINI BERLIN-CHEMIE EUROGENERICS SPIRIG HEALTHCARE EG GENERICS ARYOGEN PHARMED NOVO NORDISK AKCEA UK LTD INTAS KARAGAND.FARM.COM. BESINS HEALTHCARE