CA2948746C - Liquid pharmaceutical composition comprising adalimumab - Google Patents

Liquid pharmaceutical composition comprising adalimumab Download PDF

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Publication number
CA2948746C
CA2948746C CA2948746A CA2948746A CA2948746C CA 2948746 C CA2948746 C CA 2948746C CA 2948746 A CA2948746 A CA 2948746A CA 2948746 A CA2948746 A CA 2948746A CA 2948746 C CA2948746 C CA 2948746C
Authority
CA
Canada
Prior art keywords
pharmaceutical composition
composition
suitably
adalimumab
liquid pharmaceutical
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.)
Active
Application number
CA2948746A
Other languages
English (en)
French (fr)
Other versions
CA2948746A1 (en
Inventor
Gianluca Rinaldi
Silvia Fratarcangeli
Alessandra Del Rio
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=CA2948746(C) "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
Priority to CA3104940A priority Critical patent/CA3104940A1/en
Publication of CA2948746A1 publication Critical patent/CA2948746A1/en
Application granted granted Critical
Publication of CA2948746C publication Critical patent/CA2948746C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, 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)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Hydrogenated Pyridines (AREA)
CA2948746A 2014-05-23 2015-05-15 Liquid pharmaceutical composition comprising adalimumab Active CA2948746C (en)

Priority Applications (1)

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

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14169755.7A EP2946767B1 (en) 2014-05-23 2014-05-23 Liquid pharmaceutical composition
EP14169755.7 2014-05-23
PCT/EP2015/060818 WO2015177059A1 (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition

Related Child Applications (1)

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

Publications (2)

Publication Number Publication Date
CA2948746A1 CA2948746A1 (en) 2015-11-26
CA2948746C true CA2948746C (en) 2021-01-12

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 After (1)

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

Country Status (19)

Country Link
US (2) US10426833B2 (enExample)
EP (4) EP2946767B1 (enExample)
JP (3) JP2017516848A (enExample)
CN (2) CN111939257A (enExample)
AU (3) AU2015263247A1 (enExample)
CA (2) CA2948746C (enExample)
CY (1) CY1124493T1 (enExample)
DK (3) DK3145488T3 (enExample)
ES (2) ES2607489T3 (enExample)
HK (1) HK1231391A1 (enExample)
HR (1) HRP20201242T1 (enExample)
HU (1) HUE050779T2 (enExample)
IL (2) IL277241B (enExample)
LT (1) LT3145488T (enExample)
PT (1) PT3145488T (enExample)
RS (1) RS60801B1 (enExample)
SI (1) SI3145488T1 (enExample)
SM (1) SMT202000479T1 (enExample)
WO (1) WO2015177059A1 (enExample)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE029849T2 (en) 2014-05-23 2017-04-28 Ares Trading Sa Liquid pharmaceutical composition
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
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
US11639391B2 (en) * 2017-04-18 2023-05-02 Dr. Reddy's Laboratories Limited Stable liquid pharmaceutical composition
JP7249670B2 (ja) 2017-10-03 2023-03-31 ネヴァカー インジェクテーブルズ インコーポレイテッド アセトアミノフェン－プレガバリン組み合わせ及び疼痛を処置する方法
MX2017016884A (es) * 2017-12-19 2019-06-20 Probiomed S A De C V Formulacion farmaceutica estable de una proteina anti-tnfa.
PH12021550096A1 (en) * 2018-07-20 2022-03-28 Momenta Pharmaceuticals Inc Compositions of fcrn antibodies and methods of use thereof
AU2019307959B2 (en) 2018-07-20 2025-09-25 Momenta Pharmaceuticals, Inc. FcRn antibody compositions
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
JP2025533847A (ja) * 2022-10-07 2025-10-09 アネクソン，インコーポレーテッド 抗ｃ１ｑ抗体のための製剤
CN117257936A (zh) * 2023-10-30 2023-12-22 海正生物制药有限公司 一种阿达木单抗组合物

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
DE122004000004I1 (de) 1996-02-09 2004-08-12 Abott Biotechnology Ltd Humane Antikörper welche an Humanen TNFalpha binden.
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
HRP20050934B1 (hr) 2003-04-04 2014-09-26 Genentech, Inc. Formulacije s visokom koncentracijom antitijela i proteina
WO2005072772A1 (en) 2004-01-30 2005-08-11 Suomen Punainen Risti Veripalvelu Pharmaceutical compositions
CN101048427B (zh) 2004-07-23 2015-01-14 健泰科生物技术公司 抗体或其片段的结晶
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
JP5089582B2 (ja) 2005-06-07 2012-12-05 エスバテック、アン アルコン バイオメディカル リサーチ ユニット、エルエルシー ＴＮＦαを阻害する安定な可溶性抗体
NZ622583A (en) 2007-11-30 2015-08-28 Abbvie Biotechnology Ltd Protein formulations and methods of making same
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
EP2362767B1 (en) * 2008-10-29 2017-12-06 Ablynx N.V. Formulations of single domain antigen binding molecules
RU2560701C2 (ru) 2009-05-04 2015-08-20 Эббви Байотекнолоджи Лтд. Стабильные композиции с высокими концентрациями белков антител человека против tnf-альфа
CN107496917B (zh) * 2010-02-26 2021-06-11 诺沃—诺迪斯克有限公司 包含稳定抗体的组合物
BR112012022223B1 (pt) 2010-03-01 2022-08-09 Cytodyn Inc Formulação de proteína concentrada, uso e método de preparação da mesma
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
AU2011325974B2 (en) 2010-11-11 2016-10-27 Abbvie Biotechnology Ltd. Improved high concentration anti-TNFalpha antibody liquid formulations
EP2471554A1 (en) 2010-12-28 2012-07-04 Hexal AG Pharmaceutical formulation comprising a biopharmaceutical drug
EP2726090B1 (en) 2011-07-01 2020-01-01 Biogen MA Inc. Arginine - free tnfr : fc- fusion polypeptide compositions
GB201112429D0 (en) 2011-07-19 2011-08-31 Glaxo Group Ltd Antigen-binding proteins with increased FcRn binding
JP2015509526A (ja) * 2012-03-07 2015-03-30 カディラ ヘルスケア リミティド 医薬製剤
WO2013186230A1 (en) 2012-06-12 2013-12-19 Boehringer Ingelheim International Gmbh Pharmaceutical formulation for a therapeutic antibody
AU2013312300A1 (en) * 2012-09-07 2015-04-16 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab
CN106421782A (zh) 2012-10-25 2017-02-22 米迪缪尼有限公司 稳定的低粘度抗体配制品
AR093297A1 (es) 2012-10-31 2015-05-27 Amgen Res Munich Gmbh Formulacion liquida que comprende un compuesto neutralizante de gm-csf
WO2014068029A1 (en) 2012-10-31 2014-05-08 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
AU2013337644A1 (en) 2012-11-01 2015-05-07 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
CA2944330A1 (en) 2014-04-02 2015-10-08 Intas Pharmaceuticals Limited Liquid pharmaceutical composition of adalimumab
HUE029849T2 (en) * 2014-05-23 2017-04-28 Ares Trading Sa Liquid pharmaceutical composition
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition

Also Published As

Publication number Publication date
IL249116B (en) 2020-09-30
DK202000038U1 (da) 2020-05-18
CY1124493T1 (el) 2022-03-24
LT3145488T (lt) 2020-11-25
US10426833B2 (en) 2019-10-01
HK1231391A1 (zh) 2017-12-22
EP3741358A1 (en) 2020-11-25
US20200155677A1 (en) 2020-05-21
EP2946767A1 (en) 2015-11-25
AU2015263247A1 (en) 2016-12-01
CA3104940A1 (en) 2015-11-26
IL249116A0 (en) 2017-01-31
WO2015177059A1 (en) 2015-11-26
SI3145488T1 (sl) 2020-10-30
CA2948746A1 (en) 2015-11-26
JP2022174082A (ja) 2022-11-22
EP3145488B1 (en) 2020-07-22
AU2020286276A1 (en) 2021-01-14
DK202000030Y3 (da) 2020-05-26
IL277241B (en) 2022-08-01
SMT202000479T1 (it) 2020-11-10
AU2020204269B2 (en) 2020-09-17
HRP20201242T1 (hr) 2020-11-13
ES2815598T3 (es) 2021-03-30
EP3939566A1 (en) 2022-01-19
DK202000030U1 (da) 2020-04-28
CN111939257A (zh) 2020-11-17
AU2020286276B2 (en) 2023-06-01
EP2946767B1 (en) 2016-10-05
PT3145488T (pt) 2020-09-01
DK202000038Y3 (da) 2020-07-10
EP3145488A1 (en) 2017-03-29
CN106535935A (zh) 2017-03-22
JP2021107399A (ja) 2021-07-29
IL277241A (en) 2020-10-29
RS60801B1 (sr) 2020-10-30
HUE050779T2 (hu) 2021-01-28
DK3145488T3 (da) 2020-08-10
JP2017516848A (ja) 2017-06-22
ES2607489T3 (es) 2017-03-31
AU2020204269A1 (en) 2020-07-16
US20170182162A1 (en) 2017-06-29

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