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  1. Book ; Conference proceedings: Second European Breast Cancer Meeting Good Risks and Bad Risks: Physicians´ and Patients´ Perspectives on Adjuvant Treatment for Hormone Responsive Early Breast Cancer

    Mellstedt, H.

    20 - 21 May, 2006: Stockholm, Sweden

    (Annals of oncology ; 18, Suppl. 8)

    2007  

    Event/congress European Breast Cancer Meeting Good Risks and Bad Risks: Physicians and Patients Perspectives on Adjuvant Treatment for Hormone Responsive Early Breast Cancer (2, 2006, Stockholm)
    Author's details guest ed.: H. Mellstedt
    Series title Annals of oncology ; 18, Suppl. 8
    Collection
    Language English
    Size vii44 S. : graph. Darst.
    Publisher Oxford Univ. Press
    Publishing place Oxford
    Publishing country Great Britain
    Document type Book ; Conference proceedings
    HBZ-ID HT015382152
    Database Catalogue ZB MED Medicine, Health

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    In stock of ZB MED Cologne/Königswinter

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    Zs A 2862 -18,Suppl.8- not available for loan Zeitschriften-Lesesaal

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  2. Book ; Conference proceedings: Cancer initiatives in developing countries

    Mellstedt, H.

    30 October 2005, Paris, France ; presentations made at the Cancer Initiatives in Developing Countries Satellite Symposium of ECCO 13

    (Annals of oncology ; 17, Suppl. 8)

    2006  

    Event/congress Cancer Initiatives in Developing Countries (2005, Paris) ; European Cancer Conference (13, 2005, Paris)
    Author's details guest ed.: H. Mellstedt
    Series title Annals of oncology ; 17, Suppl. 8
    Collection
    Language English
    Size 48 S. : graph. Darst.
    Publisher Oxford Univ. Press
    Publishing place Oxford
    Publishing country Great Britain
    Document type Book ; Conference proceedings
    HBZ-ID HT014806771
    Database Catalogue ZB MED Medicine, Health

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    In stock of ZB MED Cologne/Königswinter

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    Zs A 2862 -17,Suppl.8- not available for loan Zeitschriften-Lesesaal

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  3. Article ; Online: European Perspective on Biosimilars.

    Mellstedt, Håkan

    Journal of oncology practice

    2017  Volume 13, Issue 9_suppl, Page(s) 15s–16s

    MeSH term(s) Antibodies, Monoclonal ; Biological Products ; Biosimilar Pharmaceuticals ; Drug Utilization ; Europe ; Hematinics
    Chemical Substances Antibodies, Monoclonal ; Biological Products ; Biosimilar Pharmaceuticals ; Hematinics
    Language English
    Publishing date 2017-10-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2236338-5
    ISSN 1935-469X ; 1554-7477
    ISSN (online) 1935-469X
    ISSN 1554-7477
    DOI 10.1200/JOP.2017.025569
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Clinical considerations for biosimilar antibodies.

    Mellstedt, Håkan

    EJC supplements : EJC : official journal of EORTC, European Organization for Research and Treatment of Cancer ... [et al.

    2015  Volume 11, Issue 3, Page(s) 1–11

    Abstract: Biosimilar agents are approximate copies of branded biologic therapies. Since the first biosimilar was authorized in the European Union in 2006, fifteen additional agents have been approved by the European Medicines Agency, including two biosimilar ... ...

    Abstract Biosimilar agents are approximate copies of branded biologic therapies. Since the first biosimilar was authorized in the European Union in 2006, fifteen additional agents have been approved by the European Medicines Agency, including two biosimilar monoclonal antibodies (mAbs). Biosimilar mAbs represent a distinct class given their large molecular size, complex protein structure, and post-translational modifications. While guidelines have been established for the development, approval, and use of biosimilars, further scrutiny and discussion is necessary to fully understand their potential impact on clinical outcomes. This review takes a critical look at the structural complexity of biosimilar mABs, the feasibility of indication extrapolation, the impact of product variability on immunogenicity, the importance of comprehensive pharmacovigilance, and the potential for ongoing pharmacoeconomic impact.
    Language English
    Publishing date 2015-07-26
    Publishing country England
    Document type Journal Article
    ZDB-ID 2125676-7
    ISSN 1359-6349
    ISSN 1359-6349
    DOI 10.1016/S1359-6349(13)70001-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 456 -Suppl.-: Show issues Location:
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    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 457 -Suppl.-: Show issues

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  5. Article ; Online: Introduction: ASCO-ESMO consensus statement on quality cancer care.

    Horning, S J / Mellstedt, H

    Annals of oncology : official journal of the European Society for Medical Oncology

    2019  Volume 17, Issue 7, Page(s) 1061

    Language English
    Publishing date 2019-12-10
    Publishing country England
    Document type Journal Article
    ZDB-ID 1025984-3
    ISSN 1569-8041 ; 0923-7534
    ISSN (online) 1569-8041
    ISSN 0923-7534
    DOI 10.1093/annonc/mdl164
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 2862: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
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  6. Article ; Online: Anti-neoplastic biosimilars--the same rules as for cytotoxic generics cannot be applied.

    Mellstedt, H

    Annals of oncology : official journal of the European Society for Medical Oncology

    2013  Volume 24 Suppl 5, Page(s) v23–8

    Abstract: Biopharmaceuticals are complex protein molecule drugs produced by living organisms. Biopharmaceuticals as anti-neoplastic monoclonal antibodies are a major breakthrough in oncology. When the patent of innovator biopharmaceuticals expires, copies will be ... ...

    Abstract Biopharmaceuticals are complex protein molecule drugs produced by living organisms. Biopharmaceuticals as anti-neoplastic monoclonal antibodies are a major breakthrough in oncology. When the patent of innovator biopharmaceuticals expires, copies will be introduced. These copies are after approval by European Medicines Agency (EMA) within EU called biosimilars and have their own regulatory pathways which differ from the chemical generics approval process. The main reason is that identical copies of chemical molecules via chemical syntheses can be produced but copies of innovator biopharmaceuticals will only be similar. An extensive comparability exercise has to be carried out between the reference product and the biosimilar before approval. However, still there might be differences between the innovator anti-neoplastic monoclonal antibody and the biosimilar anti-neoplastic antibody which cannot be detected until extended clinical studies have been carried out. Moreover, all indications for an anti-neoplastic biosimilar antibody may not have been tested for at the time of approval but extrapolated based on the indications of the reference monoclonal antibody. The limited information on biosimilar anti-neoplastic monoclonal antibodies at approval may still be justified taking into account that the aim is to reduce price. However, the risk-benefit ratio for biosimilar anti-neoplastic monoclonal antibodies should be carefully evaluated, considering that anti-neoplastic monoclonal antibody therapy has a curative intent, price reduction so far within EU of biosimilars is modest and that in the end only part of the total costs for cancer health care is related to biopharmaceuticals.
    MeSH term(s) Antibodies, Monoclonal/economics ; Antibodies, Monoclonal/therapeutic use ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use ; Biosimilar Pharmaceuticals/adverse effects ; Biosimilar Pharmaceuticals/economics ; Biosimilar Pharmaceuticals/therapeutic use ; Drug Approval/legislation & jurisprudence ; Europe ; Humans ; Neoplasms/drug therapy ; Neoplasms/economics
    Chemical Substances Antibodies, Monoclonal ; Antineoplastic Agents ; Biosimilar Pharmaceuticals
    Language English
    Publishing date 2013-08-23
    Publishing country England
    Document type Journal Article
    ZDB-ID 1025984-3
    ISSN 1569-8041 ; 0923-7534
    ISSN (online) 1569-8041
    ISSN 0923-7534
    DOI 10.1093/annonc/mdt325
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 2862: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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  7. Article: Billigare med biosimilarer - men säkerheten går först.

    Mellstedt, Håkan

    Lakartidningen

    2014  Volume 111, Issue 22-23, Page(s) 1011

    Title translation Cheaper with biosimilars, but safety comes first.
    MeSH term(s) Biosimilar Pharmaceuticals/economics ; Biosimilar Pharmaceuticals/standards ; Drug Approval ; Humans
    Chemical Substances Biosimilar Pharmaceuticals
    Language Swedish
    Publishing date 2014-05
    Publishing country Sweden
    Document type Letter
    ZDB-ID 391010-6
    ISSN 1652-7518 ; 0023-7205
    ISSN (online) 1652-7518
    ISSN 0023-7205
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Ua VI Zs.411: Show issues Location:
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  8. Article ; Online: Implications of the development of biosimilars for cancer treatment.

    Mellstedt, Håkan

    Future oncology (London, England)

    2010  Volume 6, Issue 7, Page(s) 1065–1067

    MeSH term(s) Antineoplastic Agents/therapeutic use ; Biopharmaceutics/economics ; Biopharmaceutics/trends ; Humans ; Neoplasms/drug therapy ; Patents as Topic ; Therapeutic Equivalency
    Chemical Substances Antineoplastic Agents
    Language English
    Publishing date 2010-07
    Publishing country England
    Document type Editorial
    ZDB-ID 2184533-5
    ISSN 1744-8301 ; 1479-6694
    ISSN (online) 1744-8301
    ISSN 1479-6694
    DOI 10.2217/fon.10.72
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

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  9. Article: Chlorambucil/Prednisone versus CHOP in Symptomatic Chronic Lymphocytic Leukemias of B-Cell type. A Randomized Trial.

    Kimby, E / Mellstedt, H

    Leukemia & lymphoma

    2016  Volume 5 Suppl 1, Page(s) 93–96

    Abstract: The therapeutic efficacy of intensive chemotherapy (CHOP) versus palliative low-dose therapy (chlorambucil/prednisone, ChP) was studied in a randomized trial including 258 previously untreated patients with asymptomatic low-grade non-Hodgkin lymphomas ... ...

    Abstract The therapeutic efficacy of intensive chemotherapy (CHOP) versus palliative low-dose therapy (chlorambucil/prednisone, ChP) was studied in a randomized trial including 258 previously untreated patients with asymptomatic low-grade non-Hodgkin lymphomas stage III and IV. The patients were stratified according to histological subgroup (the Kiel classification). 113 patients with chronic lymphocytic leukemia (CLL), including B-CLL and leukemic lymphoplasmacytoid immunocytoma (1C), were evaluated separately and presented here. The therapeutic goal was to achieve an asymptomatic state in the ChP group, while in patients allocated to CHOP the intention was to reach complete remission. Thus, in the CHOP group a higher response rate was noted than in the ChP group but no statistically significant difference in overall survival was seen. The results do not support the use of intensive chemotherapy as first line therapy in symptomatic CLL.
    Language English
    Publishing date 2016-07-27
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1042374-6
    ISSN 1029-2403 ; 1042-8194
    ISSN (online) 1029-2403
    ISSN 1042-8194
    DOI 10.3109/10428199109103386
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 2997: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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  10. Article: Biosimilar-produkter--billigare version av biologiska läkemedel. Ger nya möjligheter inom flera terapiomräden.

    Mellstedt, Håkan

    Lakartidningen

    2009  Volume 106, Issue 23, Page(s) 1563–1566

    Title translation Biosimilar products--cheaper version of biological drugs. New possibilities within several therapeutic fields.
    MeSH term(s) Antineoplastic Agents/chemistry ; Antineoplastic Agents/economics ; Antineoplastic Agents/therapeutic use ; Biological Products/chemistry ; Biological Products/economics ; Biological Products/therapeutic use ; Biopharmaceutics/economics ; Cost Savings ; Drug Approval ; Drug Costs ; Drug Information Services ; Drugs, Generic/therapeutic use ; Erythropoietin/chemistry ; Erythropoietin/therapeutic use ; Granulocyte-Macrophage Colony-Stimulating Factor/chemistry ; Granulocyte-Macrophage Colony-Stimulating Factor/therapeutic use ; Humans ; Interferons/chemistry ; Interferons/therapeutic use ; Neoplasms/drug therapy ; Recombinant Proteins/economics ; Recombinant Proteins/therapeutic use ; Technology, Pharmaceutical ; Therapeutic Equivalency ; Treatment Outcome
    Chemical Substances Antineoplastic Agents ; Biological Products ; Drugs, Generic ; Recombinant Proteins ; Erythropoietin (11096-26-7) ; Granulocyte-Macrophage Colony-Stimulating Factor (83869-56-1) ; Interferons (9008-11-1)
    Language Swedish
    Publishing date 2009-06
    Publishing country Sweden
    Document type Journal Article ; Review
    ZDB-ID 391010-6
    ISSN 1652-7518 ; 0023-7205
    ISSN (online) 1652-7518
    ISSN 0023-7205
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Ua VI Zs.411: Show issues Location:
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