AR091967A1 - Articulo de fabricacion que comprende aflibercept o 2iv-aflibercept - Google Patents

Articulo de fabricacion que comprende aflibercept o 2iv-aflibercept

Info

Publication number
AR091967A1
AR091967A1 ARP130102744A ARP130102744A AR091967A1 AR 091967 A1 AR091967 A1 AR 091967A1 AR P130102744 A ARP130102744 A AR P130102744A AR P130102744 A ARP130102744 A AR P130102744A AR 091967 A1 AR091967 A1 AR 091967A1
Authority
AR
Argentina
Prior art keywords
biosimilar
polypeptide
patients
interrupted
seq
Prior art date
Application number
ARP130102744A
Other languages
English (en)
Inventor
Castan Remi
Assadourian Sylvie
Magherini Emmanuelle
Original Assignee
Sanofi Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi Sa filed Critical Sanofi Sa
Publication of AR091967A1 publication Critical patent/AR091967A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/4738Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1858Platelet-derived growth factor [PDGF]
    • A61K38/1866Vascular endothelial growth factor [VEGF]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D85/00Containers, packaging elements or packages, specially adapted for particular articles or materials
    • B65D85/70Containers, packaging elements or packages, specially adapted for particular articles or materials for materials not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Mechanical Engineering (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Wrappers (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Reivindicación 1: Un artículo de fabricación que comprende: a) un material de envasado, b) un polipéptido de SEQ ID Nº 1, o un biosimilar de éste, y c) una etiqueta o prospecto contenido en dicho envase, comprendiendo dicha etiqueta una declaración impresa que informa a un usuario potencial que: el polipéptido, o biosimilar de éste, no debe administrarse a pacientes con una hemorragia grave, y/o la terapia debe interrumpirse en pacientes que experimentan perforación gastrointestinal, y/o la terapia debe interrumpirse en pacientes con cicatrización de heridas comprometida. Reivindicación 10: Un método para promover el uso de un polipéptido de SEQ ID Nº 1, o un biosimilar de éste, comprendiendo el método la etapa de transmitir en un recipiente al menos un mensaje seleccionado del grupo que consiste en: a) el polipéptido, o biosimilar de éste, no debe administrarse a pacientes con una hemorragia grave, y/o b) el polipéptido, o biosimilar de éste, debe interrumpirse en pacientes que experimentan perforación gastrointestinal, y/o c) el polipéptido, o biosimilar de éste, debe interrumpirse en pacientes con cicatrización de heridas comprometida. Reivindicación 11: Un método para tratar cáncer o síntomas del cáncer en un paciente que lo necesita, comprendiendo dicho método administrar a dicho paciente cantidades terapéuticamente eficaces de un polipéptido de SEQ ID Nº 1, o biosimilar de éste, en el que: a) el polipéptido, o biosimilar de éste, no debe administrarse a pacientes con una hemorragia grave, y/o b) el polipéptido, o biosimilar de éste, debe interrumpirse en pacientes que experimentan perforación gastrointestinal, y/o c) el polipéptido, o biosimilar de éste, debe interrumpirse en pacientes con cicatrización de heridas comprometida. Reivindicación 12: Un método para tratar Cáncer Colorrectal (CRC) o síntomas de Cáncer Colorrectal (CRC) en un paciente que lo necesita, comprendiendo dicho método administrar a dicho paciente cantidades terapéuticamente eficaces de un polipéptido de SEQ ID Nº 1, o biosimilar de éste, ácido folínico, 5-fluorouracilo (5-FU) e irinotecán en el que: a) el polipéptido, o biosimilar de éste, no debe administrarse a pacientes con una hemorragia grave, y/o b) el polipéptido, o biosimilar de éste, debe interrumpirse en pacientes que experimentan perforación gastrointestinal, y/o c) el polipéptido, o biosimilar de éste, debe interrumpirse en pacientes con cicatrización de heridas comprometida. Reivindicación 31: Polipéptido de SEQ ID Nº 1, o biosimilar de éste, para uso en el tratamiento de pacientes con cáncer o síntomas de cáncer en el que: a) el polipéptido, o biosimilar de éste, no debe administrarse a pacientes con una hemorragia grave, y/o b) el polipéptido, o biosimilar de éste, debe interrumpirse en pacientes que experimentan perforación gastrointestinal, y/o c) el polipéptido, o biosimilar de éste, debe interrumpirse en pacientes con cicatrización de heridas comprometida. Reivindicación 33: Composición que comprende cantidades terapéuticamente eficaces de un polipéptido de SEQ ID Nº 1, o biosimilar de éste, en combinación con ácido folínico, 5-fluorouracilo (5-FU) e irinocetán y que comprende un vehículo farmacéuticamente aceptable para uso en el tratamiento de pacientes con Cáncer Colorrectal (CRC) o síntomas de Cáncer Colorrectal (CRC) en el que: a) el polipéptido, o biosimilar de éste, no debe administrarse a pacientes con una hemorragia grave, y/o b) el polipéptido, o biosimilar de éste, debe interrumpirse en pacientes que experimentan perforación gastrointestinal, y/o c) el polipéptido, o biosimilar de éste, debe interrumpirse en pacientes con cicatrización de heridas comprometida.
ARP130102744A 2012-08-02 2013-08-02 Articulo de fabricacion que comprende aflibercept o 2iv-aflibercept AR091967A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261678983P 2012-08-02 2012-08-02
US201261679490P 2012-08-03 2012-08-03

Publications (1)

Publication Number Publication Date
AR091967A1 true AR091967A1 (es) 2015-03-11

Family

ID=48917540

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP130102744A AR091967A1 (es) 2012-08-02 2013-08-02 Articulo de fabricacion que comprende aflibercept o 2iv-aflibercept

Country Status (17)

Country Link
US (2) US20150216795A1 (es)
EP (1) EP2879694A1 (es)
JP (1) JP2015526430A (es)
KR (1) KR20150038297A (es)
CN (1) CN104853763A (es)
AR (1) AR091967A1 (es)
AU (1) AU2013298521A1 (es)
CA (1) CA2888281A1 (es)
EA (1) EA201590305A1 (es)
HK (1) HK1206628A1 (es)
IL (1) IL236931A0 (es)
MX (1) MX2015001550A (es)
SG (1) SG11201500480TA (es)
TW (1) TW201408316A (es)
UY (1) UY34962A (es)
WO (1) WO2014020160A1 (es)
ZA (1) ZA201500485B (es)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JO3283B1 (ar) 2011-04-26 2018-09-16 Sanofi Sa تركيب يتضمن أفليبيرسيبت, حمض فولينيك, 5- فلورويوراسيل (5- Fu) وإرينوسيتان (FOLFIRI)
AR095196A1 (es) 2013-03-15 2015-09-30 Regeneron Pharma Medio de cultivo celular libre de suero
US9840553B2 (en) 2014-06-28 2017-12-12 Kodiak Sciences Inc. Dual PDGF/VEGF antagonists
HUE043951T2 (hu) 2014-07-18 2019-09-30 Sanofi Sa Eljárás rákgyanús beteg aflibercepttel történõ kezelése kimenetének elõrejelzésére
CN107922095A (zh) 2015-06-17 2018-04-17 诺维信公司 容器
TWI797060B (zh) 2015-08-04 2023-04-01 美商再生元醫藥公司 補充牛磺酸之細胞培養基及用法
KR101936049B1 (ko) * 2015-10-15 2019-01-08 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 생산방법
KR20180104635A (ko) 2015-12-30 2018-09-21 코디악 사이언시스 인코포레이티드 항체 및 이의 접합체
MX2018009112A (es) * 2016-01-25 2018-08-28 Sanofi Sa Metodo para predecir el resultado de un tratamiento con aflibercept de un paciente que se sospecha que padece un cancer mediante la medicion del nivel de un biomarcador plasmatico.
CA3067847A1 (en) * 2017-07-06 2019-01-10 Regeneron Pharmaceuticals, Inc. Cell culture process for making a glycoprotein
CN109929027B (zh) * 2017-12-15 2020-10-09 山东博安生物技术有限公司 采用线性洗脱步骤的重组融合蛋白纯化方法
CN109929038B (zh) * 2017-12-15 2020-10-09 山东博安生物技术有限公司 Vegf捕获剂融合蛋白的纯化方法
EP3863657A4 (en) * 2018-10-12 2022-07-20 Trican Biotechnology Co., Ltd BIFUNCTIONAL FUSION PROTEINS AND USES THEREOF
CA3127228A1 (en) * 2019-01-30 2020-08-06 Amgen Inc. Aflibercept attributes and methods of characterizing and modifying thereof
CA3157509A1 (en) 2019-10-10 2021-04-15 Kodiak Sciences Inc. Methods of treating an eye disorder
SG11202110955VA (en) 2019-12-06 2021-10-28 Regeneron Pharma Anti-vegf protein compositions and methods for producing the same

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI2586459T1 (sl) * 2005-03-25 2017-10-30 Regeneron Pharmaceuticals, Inc. Formulacije antagonistov VEGF
JO3283B1 (ar) * 2011-04-26 2018-09-16 Sanofi Sa تركيب يتضمن أفليبيرسيبت, حمض فولينيك, 5- فلورويوراسيل (5- Fu) وإرينوسيتان (FOLFIRI)

Also Published As

Publication number Publication date
WO2014020160A1 (en) 2014-02-06
MX2015001550A (es) 2015-05-11
US20150216795A1 (en) 2015-08-06
IL236931A0 (en) 2015-03-31
EP2879694A1 (en) 2015-06-10
KR20150038297A (ko) 2015-04-08
SG11201500480TA (en) 2015-02-27
TW201408316A (zh) 2014-03-01
JP2015526430A (ja) 2015-09-10
US20180078496A1 (en) 2018-03-22
AU2013298521A1 (en) 2015-02-26
HK1206628A1 (en) 2016-01-15
CN104853763A (zh) 2015-08-19
EA201590305A1 (ru) 2015-06-30
ZA201500485B (en) 2017-07-26
CA2888281A1 (en) 2014-02-06
UY34962A (es) 2014-02-28

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