CA3104940A1 - Liquid pharmaceutical composition comprising adalimumab - Google Patents

Liquid pharmaceutical composition comprising adalimumab

Info

Publication number
CA3104940A1
CA3104940A1 CA3104940A CA3104940A CA3104940A1 CA 3104940 A1 CA3104940 A1 CA 3104940A1 CA 3104940 A CA3104940 A CA 3104940A CA 3104940 A CA3104940 A CA 3104940A CA 3104940 A1 CA3104940 A1 CA 3104940A1
Authority
CA
Canada
Prior art keywords
suitably
liquid pharmaceutical
pharmaceutical composition
adalimumab
citrate
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
CA3104940A
Other languages
English (en)
French (fr)
Inventor
Alessandra Del Rio
Silvia Fratarcangeli
Gianluca Rinaldi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50774706&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA3104940(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of CA3104940A1 publication Critical patent/CA3104940A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • 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
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Hydrogenated Pyridines (AREA)
CA3104940A 2014-05-23 2015-05-15 Liquid pharmaceutical composition comprising adalimumab Abandoned CA3104940A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14169755.7 2014-05-23
EP14169755.7A EP2946767B1 (en) 2014-05-23 2014-05-23 Liquid pharmaceutical composition
CA2948746A CA2948746C (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition comprising adalimumab

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA2948746A Division CA2948746C (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition comprising adalimumab

Publications (1)

Publication Number Publication Date
CA3104940A1 true CA3104940A1 (en) 2015-11-26

Family

ID=50774706

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2948746A Active CA2948746C (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition comprising adalimumab
CA3104940A Abandoned CA3104940A1 (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition comprising adalimumab

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2948746A Active CA2948746C (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition comprising adalimumab

Country Status (19)

Country Link
US (2) US10426833B2 (OSRAM)
EP (4) EP2946767B1 (OSRAM)
JP (3) JP2017516848A (OSRAM)
CN (2) CN106535935A (OSRAM)
AU (3) AU2015263247A1 (OSRAM)
CA (2) CA2948746C (OSRAM)
CY (1) CY1124493T1 (OSRAM)
DK (3) DK3145488T3 (OSRAM)
ES (2) ES2607489T3 (OSRAM)
HK (1) HK1231391A1 (OSRAM)
HR (1) HRP20201242T1 (OSRAM)
HU (1) HUE050779T2 (OSRAM)
IL (2) IL277241B (OSRAM)
LT (1) LT3145488T (OSRAM)
PT (1) PT3145488T (OSRAM)
RS (1) RS60801B1 (OSRAM)
SI (1) SI3145488T1 (OSRAM)
SM (1) SMT202000479T1 (OSRAM)
WO (1) WO2015177059A1 (OSRAM)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2600488T3 (es) 2014-05-23 2017-02-09 Ares Trading S.A. Composición farmacéutica líquida
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
CN105543204A (zh) * 2015-12-30 2016-05-04 海口奇力制药股份有限公司 一种组合物及其应用、含有该组合物的稳定剂
WO2017177160A1 (en) 2016-04-07 2017-10-12 Nevakar Llc Formulation for use in a method of treatment of pain
EP4467565A3 (en) 2016-12-21 2025-03-12 Amgen Inc. Anti-tnf alpha antibody formulations
BR112019021723A2 (pt) * 2017-04-18 2021-06-29 Dr. Reddy's Laboratories Limited formulação de anticorpo líquida estável, anticorpo na formulação, formulação líquida estável de anticorpo anti-il6r, formulação líquida estável de tocilizumab em sistema de tampão de fosfato-aminoácido, e, formulação líquida estável de tocilizumab
CN111432882A (zh) * 2017-10-03 2020-07-17 内瓦卡公司 对乙酰氨基酚-普瑞巴林组合和治疗疼痛的方法
MX2017016884A (es) * 2017-12-19 2019-06-20 Probiomed S A De C V Formulacion farmaceutica estable de una proteina anti-tnfa.
CA3106669A1 (en) * 2018-07-20 2020-01-30 Momenta Pharmaceuticals, Inc. Compositions of fcrn antibodies and methods of use thereof
CN113134081A (zh) * 2020-01-20 2021-07-20 上海君实生物医药科技股份有限公司 抗btla抗体药物组合物及其用途
IL319755A (en) * 2022-10-07 2025-05-01 Annexon Inc Anti-C1Q antibody formulations

Family Cites Families (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6388197A (ja) 1986-09-30 1988-04-19 Tosoh Corp モノクロナル抗体の安定化方法
BRPI9707379B8 (pt) 1996-02-09 2015-07-07 Abbvie Biotechnology Ltd Composições farmacêuticas compreendendo anticorpo humano recombinante geneticamente engenheirado, e anticorpo humano recombinante geneticamente engenheirado.
US5900404A (en) 1997-08-15 1999-05-04 Amgen Inc. Chemical modification of proteins to improve biocompatibility and bioactivity
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
BRPI0403964B8 (pt) 2003-04-04 2021-05-25 Genentech Inc formulações líquidas estáveis, artigo manufaturado e uso dessas formulações para o tratamento de disfunção mediada por ige
WO2005072772A1 (en) 2004-01-30 2005-08-11 Suomen Punainen Risti Veripalvelu Pharmaceutical compositions
BRPI0513601A (pt) 2004-07-23 2008-05-13 Genentech Inc métodos de produção de cristais de anticorpo ou seu fragmento, composições, formulação, cristal de anticorpo ou seu fragmento, método de tratamento e métodos de produção de cristais e de gel de proteìna de anticorpo ou seu fragmento
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
PL2390267T3 (pl) 2005-06-07 2013-09-30 Esbatech A Novartis Co Llc Stabilne i rozpuszczalne przeciwciała hamujące TNF(alfa)
CN101969971A (zh) * 2007-11-30 2011-02-09 雅培制药有限公司 蛋白制剂及其制备方法
US8080518B2 (en) 2007-12-05 2011-12-20 Arbor Vita Corporation Co-administration of an agent linked to an internalization peptide with an anti-inflammatory
US9393304B2 (en) * 2008-10-29 2016-07-19 Ablynx N.V. Formulations of single domain antigen binding molecules
CN104490767A (zh) 2009-05-04 2015-04-08 艾伯维生物技术有限公司 人抗TNF-α抗体的稳定高蛋白质浓度制剂
EP3216462A3 (en) * 2010-02-26 2017-12-20 Novo Nordisk A/S Stable antibody containing compositions
RU2626512C2 (ru) 2010-03-01 2017-07-28 Цитодин, Инк. Концентрированные белковые фармацевтические составы и их применение
US20110223208A1 (en) 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
EP2399604A1 (en) 2010-06-25 2011-12-28 F. Hoffmann-La Roche AG Novel antibody formulation
US8821865B2 (en) 2010-11-11 2014-09-02 Abbvie Biotechnology Ltd. High concentration anti-TNFα antibody liquid formulations
EP2471554A1 (en) 2010-12-28 2012-07-04 Hexal AG Pharmaceutical formulation comprising a biopharmaceutical drug
MX358137B (es) 2011-07-01 2018-08-06 Biogen Idec Inc Composiciones del polipéptido de fusión tnfr: fc exentas de arginina y métodos de uso.
GB201112429D0 (en) 2011-07-19 2011-08-31 Glaxo Group Ltd Antigen-binding proteins with increased FcRn binding
HK1200709A1 (en) * 2012-03-07 2015-08-14 Cadila Healthcare Limited Pharmaceutical formulations of tnf-alpha antibodies
US20150150982A1 (en) 2012-06-12 2015-06-04 Boehringer Ingelheim International Gmbh Pharmaceutical formulation for a therapeutic antibody
WO2014039903A2 (en) 2012-09-07 2014-03-13 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab
US20150239970A1 (en) 2012-10-25 2015-08-27 Medimmune, Llc Stable, Low Viscosity Antibody Formulation
AR093297A1 (es) 2012-10-31 2015-05-27 Amgen Res Munich Gmbh Formulacion liquida que comprende un compuesto neutralizante de gm-csf
US9833410B2 (en) 2012-10-31 2017-12-05 Takeda Gmbh Lyophilized formulation comprising GM-CSF neutralizing compound
EP2727602A1 (en) 2012-10-31 2014-05-07 Takeda GmbH Method for preparation of a high concentration liquid formulation of an antibody
CA2889488A1 (en) 2012-11-01 2014-05-08 Abbvie Inc. Stable dual variable domain immunoglobulin protein formulations
CN104707146B (zh) 2013-12-16 2019-04-16 浙江海正药业股份有限公司 一种含有阿达木单抗的药物组合物
IN2014MU01248A (OSRAM) 2014-04-02 2015-10-09 Intas Pharmaceuticals Ltd
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
ES2600488T3 (es) * 2014-05-23 2017-02-09 Ares Trading S.A. Composición farmacéutica líquida

Also Published As

Publication number Publication date
EP3145488A1 (en) 2017-03-29
HUE050779T2 (hu) 2021-01-28
EP2946767B1 (en) 2016-10-05
IL249116B (en) 2020-09-30
DK202000030U1 (da) 2020-04-28
US20170182162A1 (en) 2017-06-29
DK202000038Y3 (da) 2020-07-10
EP3741358A1 (en) 2020-11-25
CN111939257A (zh) 2020-11-17
SI3145488T1 (sl) 2020-10-30
AU2015263247A1 (en) 2016-12-01
IL277241A (en) 2020-10-29
ES2607489T3 (es) 2017-03-31
JP2022174082A (ja) 2022-11-22
HRP20201242T1 (hr) 2020-11-13
AU2020286276A1 (en) 2021-01-14
EP2946767A1 (en) 2015-11-25
CN106535935A (zh) 2017-03-22
AU2020204269A1 (en) 2020-07-16
EP3939566A1 (en) 2022-01-19
WO2015177059A1 (en) 2015-11-26
DK202000038U1 (da) 2020-05-18
CA2948746A1 (en) 2015-11-26
US20200155677A1 (en) 2020-05-21
RS60801B1 (sr) 2020-10-30
DK202000030Y3 (da) 2020-05-26
JP2017516848A (ja) 2017-06-22
AU2020286276B2 (en) 2023-06-01
DK3145488T3 (da) 2020-08-10
SMT202000479T1 (it) 2020-11-10
HK1231391A1 (zh) 2017-12-22
CY1124493T1 (el) 2022-03-24
CA2948746C (en) 2021-01-12
LT3145488T (lt) 2020-11-25
AU2020204269B2 (en) 2020-09-17
US10426833B2 (en) 2019-10-01
ES2815598T3 (es) 2021-03-30
IL277241B (en) 2022-08-01
EP3145488B1 (en) 2020-07-22
JP2021107399A (ja) 2021-07-29
PT3145488T (pt) 2020-09-01
IL249116A0 (en) 2017-01-31

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Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20210330

EEER Examination request

Effective date: 20210330

FZDE Discontinued

Effective date: 20230724