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  1. Article: The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019

    Kang, Hye-Na / Thorpe, Robin / Knezevic, Ivana / Blades, Carolina Damas Rocha Zarate / Casas Levano, Mary / Chew, Jing Yin / Chilufya, Mumbi Bernice / Chirachanakul, Parichard / Chua, Hui Ming / Farahani, Ali Vasheghani / Ghobrial, Mariam Raouf Wefky / Habahbeh, Suna / Hamel, Hugo / Kim, Gi Hyun / Perez Rodriguez, Violeta / Putri, Desi Eka / Rodgers, Jacqueline / Savkina, Maria / Semeniuk, Oleh /
    Srivastava, Shraddha / Wadhwa, Meenu / Yamaguchi, Teruhide

    Biologicals. 2020 May, v. 65

    2020  

    Abstract: The World Health Assembly in 2014 adopted a resolution that mandates both Member States and the WHO Secretariat to facilitate access to biotherapeutic products in a way that ensures their quality, safety and efficacy. The availability of biosimilars is ... ...

    Institution Survey participants from 19 countries
    Abstract The World Health Assembly in 2014 adopted a resolution that mandates both Member States and the WHO Secretariat to facilitate access to biotherapeutic products in a way that ensures their quality, safety and efficacy. The availability of biosimilars is expected to increase access to biotherapeutic products by providing more treatment options triggering competition which would lead to a consistent reduction in the average price of treatment. Since the WHO guidelines for regulatory evaluation of biosimilars were issued in 2009, WHO has provided immense effort towards harmonizing the terminology and the regulatory framework for biosimilars globally. This article describes the progress made and the regulatory landscape changes for biosimilars in 21 countries during the past ten years. Based on the information from regulators and from publicly available data, the following has been identified: 1) WHO guidelines have contributed to setting the regulatory framework for biosimilars in countries and increasing regulatory convergence at global level; 2) terminology used for biosimilars is more consistent than in the past; 3) biosimilars are now approved in all participating countries; and 4) the dominant product class for candidate biosimilars under development is monoclonal antibodies.
    Keywords guidelines ; information ; landscapes ; lead ; monoclonal antibodies ; prices ; terminology
    Language English
    Dates of publication 2020-05
    Size p. 1-9.
    Publishing place Elsevier Ltd
    Document type Article
    Note NAL-light
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2020.02.005
    Database NAL-Catalogue (AGRICOLA)

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  2. Article ; Online: Regulatory challenges with biosimilars: an update from 20 countries.

    Kang, Hye-Na / Thorpe, Robin / Knezevic, Ivana / Casas Levano, Mary / Chilufya, Mumbi Bernice / Chirachanakul, Parichard / Chua, Hui Ming / Dalili, Dina / Foo, Freddie / Gao, Kai / Habahbeh, Suna / Hamel, Hugo / Kim, Gi Hyun / Perez Rodriguez, Violeta / Putri, Desi Eka / Rodgers, Jacqueline / Savkina, Maria / Semeniuk, Oleh / Srivastava, Shraddha /
    Tavares Neto, João / Wadhwa, Meenu / Yamaguchi, Teruhide

    Annals of the New York Academy of Sciences

    2020  Volume 1491, Issue 1, Page(s) 42–59

    Abstract: The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory ... ...

    Abstract The World Health Organization (WHO) issued guidelines for the regulatory evaluation of biosimilars in 2009 and has provided considerable effort toward helping member states implement the evaluation principles in the guidelines into their regulatory practices. Despite this effort, a recent WHO survey (conducted in 2019-2020) has revealed four main remaining challenges: unavailable/insufficient reference products in the country; lack of resources; problems with the quality of some biosimilars (and even more with noninnovator products); and difficulties with the practice of interchangeability and naming of biosimilars. The following have been identified as opportunities/solutions for regulatory authorities to deal with the existing challenges: (1) exchange of information on products with other regulatory authorities and accepting foreign licensed and sourced reference products, hence avoiding conducting unnecessary (duplicate) bridging studies; (2) use of a "reliance" concept and/or joint review for the assessment and approval of biosimilars; (3) review and reassessment of the products already approved before the establishment of a regulatory framework for biosimilar approval; and (4) setting appropriate regulatory oversight for good pharmacovigilance, which is essential for the identification of problems with products and establishing the safety and efficacy of interchangeability of biosimilars.
    MeSH term(s) Biosimilar Pharmaceuticals/standards ; Drug Approval ; Guidelines as Topic ; Health Information Exchange ; Humans ; Pharmacovigilance ; Surveys and Questionnaires ; World Health Organization
    Chemical Substances Biosimilar Pharmaceuticals
    Language English
    Publishing date 2020-11-21
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 211003-9
    ISSN 1749-6632 ; 0077-8923
    ISSN (online) 1749-6632
    ISSN 0077-8923
    DOI 10.1111/nyas.14522
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Conference proceedings: WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25–26 June 2019

    Wadhwa, Meenu / Kang, Hye-Na / Jivapaisarnpong, Teeranart / Ahmed, Aziza / Andalucia, Lucia Rizka / Blades, Carolina Damas Rocha Zarate / Casas Levano, Mary / Chang, Weihong / Chew, Jing Yin / Chilufya, Mumbi Bernice / Chirachanakul, Parichard / Cho, Heeyoun (Gloria) / Cho, Yi O / Choi, Kyung Min / Chong, Sannie / Chua, Hui Ming / Farahani, Ali Vasheghani / Gencoglu, Mumun / Ghobrial, Mariam Raouf Wefky /
    Guha, Prasunkumar / Gutierrez Lugo, Maria-Teresa / Ha, Sung Bae / Habahbeh, Suna / Hamel, Hugo / Hong, Yeosun / Iarutkin, Aleksei / Jang, Hyunsook / Jayachandran, Ramalingam / Kim, Dong-young / Kim, Gi Hyun / Kim, Yunjeong / Kwon, Hyuk-Sang / Larsen, Jacob / Lee, Aileen HyoJu / Lee, Jiyoung / Medvedeva, Ksenia / Munkombwe, Zuma / Oh, IlUng / Park, Jooyoung / Putri, Desi Eka / Rodgers, Jacqueline / Ryu, Sungmun / Savkina, Maria / Schreitmueller, Thomas / Semeniuk, Oleh / Seo, Mira / Shin, Yung In / Shin, Jinho / Srivastava, Shraddha / Song, HyeonHo / Song, Suwon / Tavares Neto, João / Yamaguchi, Teruhide / Youn, Hyun-Jun (David) / Yun, Minae

    Biologicals. 2020 May, v. 65

    2020  

    Abstract: The first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adopted by the WHO Expert Committee in 2018 was held in June 2019. The workshop participants recognized ... ...

    Institution WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products
    Abstract The first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adopted by the WHO Expert Committee in 2018 was held in June 2019. The workshop participants recognized that the principles based on sound science and the potential for risk, as described in the WHO Guidelines on post-approval changes, which constitute the global standard for product life-cycle management are providing clarity and helping national regulatory authorities in establishing guidance while improving time-lines for an efficient regulation of products. Consequently, the regulatory situation for post-approval changes and guideline implementation is changing but there is a disparity between different countries. While the guidelines are gradually being implemented in some countries and also being considered in other countries, the need for regional workshops and further training on post-approval changes was a common theme reiterated by many participants. Given the complexities relating to post-approval changes in different regions/countries, there was a clear understanding among all participants that an efficient approach for product life-cycle management at a national level is needed to ensure faster availability of high standard, safe and efficacious medicines to patients as per the World Health Assembly Resolution 67.21.
    Keywords World Health Organization ; guidelines ; patients ; product life cycle ; risk ; South Korea
    Language English
    Dates of publication 2020-05
    Size p. 50-59.
    Publishing place Elsevier Ltd
    Document type Article ; Conference proceedings
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2019.12.008
    Database NAL-Catalogue (AGRICOLA)

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  4. Article ; Online: WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019.

    Wadhwa, Meenu / Kang, Hye-Na / Jivapaisarnpong, Teeranart / Andalucia, Lucia Rizka / Blades, Carolina Damas Rocha Zarate / Casas Levano, Mary / Chang, Weihong / Chew, Jing Yin / Chilufya, Mumbi Bernice / Chirachanakul, Parichard / Cho, Heeyoun Gloria / Cho, Yi O / Choi, Kyung Min / Chong, Sannie / Chua, Hui Ming / Farahani, Ali Vasheghani / Gencoglu, Mumun / Ghobrial, Mariam Raouf Wefky / Guha, Prasunkumar /
    Gutierrez Lugo, Maria-Teresa / Ha, Sung Bae / Habahbeh, Suna / Hamel, Hugo / Hong, Yeosun / Iarutkin, Aleksei / Jang, Hyunsook / Jayachandran, Ramalingam / Kim, Dong-Young / Kim, Gi Hyun / Kim, Yunjeong / Kwon, Hyuk-Sang / Larsen, Jacob / Lee, Aileen HyoJu / Lee, Jiyoung / Medvedeva, Ksenia / Munkombwe, Zuma / Oh, IlUng / Park, Jooyoung / Putri, Desi Eka / Rodgers, Jacqueline / Ryu, Sungmun / Savkina, Maria / Schreitmueller, Thomas / Semeniuk, Oleh / Seo, Mira / Shin, Yung In / Shin, Jinho / Srivastava, Shraddha / Song, HyeonHo / Song, Suwon / Tavares Neto, João / Yamaguchi, Teruhide / Youn, Hyun-Jun David / Yun, Minae

    Biologicals : journal of the International Association of Biological Standardization

    2020  Volume 65, Page(s) 50–59

    Abstract: The first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adopted by the WHO Expert Committee in 2018 was held in June 2019. The workshop participants recognized ... ...

    Abstract The first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adopted by the WHO Expert Committee in 2018 was held in June 2019. The workshop participants recognized that the principles based on sound science and the potential for risk, as described in the WHO Guidelines on post-approval changes, which constitute the global standard for product life-cycle management are providing clarity and helping national regulatory authorities in establishing guidance while improving time-lines for an efficient regulation of products. Consequently, the regulatory situation for post-approval changes and guideline implementation is changing but there is a disparity between different countries. While the guidelines are gradually being implemented in some countries and also being considered in other countries, the need for regional workshops and further training on post-approval changes was a common theme reiterated by many participants. Given the complexities relating to post-approval changes in different regions/countries, there was a clear understanding among all participants that an efficient approach for product life-cycle management at a national level is needed to ensure faster availability of high standard, safe and efficacious medicines to patients as per the World Health Assembly Resolution 67.21.
    MeSH term(s) Biological Products/standards ; Drug Approval ; Drug Evaluation/standards ; Drug and Narcotic Control ; Guidelines as Topic ; Humans ; Seoul ; World Health Organization
    Chemical Substances Biological Products
    Language English
    Publishing date 2020-01-17
    Publishing country England
    Document type Clinical Conference ; Journal Article
    ZDB-ID 1017370-5
    ISSN 1095-8320 ; 1045-1056
    ISSN (online) 1095-8320
    ISSN 1045-1056
    DOI 10.1016/j.biologicals.2019.12.008
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

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