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, C.; Levano, Mary Casas; Chang, Weihong; Chew, Jing Yin; Chilufya, Mumbi Bernice; Chirachanakul, Parichard; Cho, Heeyoun; Cho, Yi O.; Choi, Kyung Min; Chong, Sannie Siaw Foong; Chua, Hui Ming; Farahani, Ali Vasheghani; Gencoglu, Mumun; Ghobrial, Mariam Raouf Wefky; Guha, Prasunkumar; Lugo, Maria-Teresa Gutierrez; Ha, Sung Bae; Habahbeh, Suna; Hamel, Hugo; Hong, Yeosun; Yarutkin, A. V.; Jang, Hyunsook; Jayachandran, R.; Kim, Dong‐Young; Kim, Gi Hyun; Kim, Yun-Jeong; Kwon, Hyuk Tae; Larsen, Jacob Gorm; Lee, Aileen HyoJu; Lee, Ji-Young; Medvedeva, Ksenia; Munkombwe, Zuma; Oh, IlUng; Park, Jooyoung; Putri, Desi Eka; Rodgers, Jacqui; Ryu, Sungmun; Savkina, Maria; Schreitmueller, Thomas; Semeniuk, Oleh; Seo, Minhye; Shin, Yung In; Shin, Jin-Ho; Srivastava, Shraddha; Song, HyeonHo; Song, Suwon; Neto, João Tavares; Yamaguchi, Teruhide; Youn, Hyun-Jun; Yun, Minae

doi:10.1016/j.biologicals.2019.12.008

Cited by 3 publications

(3 citation statements)

References 17 publications

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“…4 WHO Guidelines on postapproval changes to biotherapeutic products as well as supporting materials and technical assistance to countries have been provided. 17,24 This area requires further activity to improve the situation at the global level.…”

Section: Discussionmentioning

confidence: 99%

“…Since there is evidence that the concept of reliance based on information and approval from an experienced regulatory agency in the area of evaluation of postapproval changes of biotherapeutics operates well and improves efficiency in some countries (e.g., Brazil (pilot), Ghana, and Singapore), it could offer an opportunity for an efficient and effective regulatory process for biosimilar evaluation in countries with limited resources. 17 Regulatory authorities can facilitate access to biosimilars by reducing the time and improving the efficiency of their review without compromising its quality. Regulatory authorities, especially in countries with limited regulatory resources, should organize their activities to avoid repeating assessments/evaluations for products that have already undergone rigorous evaluation in other countries, as was recommended by ICDRA in 2014.…”

Section: Lack Of Resourcesmentioning

confidence: 99%

See 1 more Smart Citation

Regulatory challenges with biosimilars: an update from 20 countries

Kang

Thorpe²,

Knežević

et al. 2020

Annals of the New York Academy of Sciences

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Lack Of Resourcesmentioning

confidence: 99%

Regulatory challenges with biosimilars: an update from 20 countries

Kang

Thorpe²,

Knežević

et al. 2020

Annals of the New York Academy of Sciences

Self Cite

View full text Add to dashboard Cite

show abstract

“…Furthermore, global harmonization of regulatory standards spearheaded by organizations like the World Health Organization and the International Council for Harmonization is crucial. These efforts aim to standardize safety, quality, and efficacy evaluations for EV therapies worldwide, facilitating their global adoption [ 179 ].…”

Section: Clinical Translation and The Regulatory Landscape For Engine...mentioning

confidence: 99%

Optimizing mesenchymal stem cell extracellular vesicles for chronic wound healing: Bioengineering, standardization, and safety

Shimizu,

Ntege,

Inoue

et al. 2024

Regenerative Therapy

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Biosimilars in the Era of Artificial Intelligence—International Regulations and the Use in Oncological Treatments

Bas,

Duarte

2024

Pharmaceuticals

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This research is based on three fundamental aspects of successful biosimilar development in the challenging biopharmaceutical market. First, biosimilar regulations in eight selected countries: Japan, South Korea, the United States, Canada, Brazil, Argentina, Australia, and South Africa, represent the four continents. The regulatory aspects of the countries studied are analyzed, highlighting the challenges facing biosimilars, including their complex approval processes and the need for standardized regulatory guidelines. There is an inconsistency depending on whether the biosimilar is used in a developed or developing country. In the countries observed, biosimilars are considered excellent alternatives to patent-protected biological products for the treatment of chronic diseases. In the second aspect addressed, various analytical AI modeling methods (such as machine learning tools, reinforcement learning, supervised, unsupervised, and deep learning tools) were analyzed to observe patterns that lead to the prevalence of biosimilars used in cancer to model the behaviors of the most prominent active compounds with spectroscopy. Finally, an analysis of the use of active compounds of biosimilars used in cancer and approved by the FDA and EMA was proposed.

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WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25–26 June 2019

Cited by 3 publications

References 17 publications

Regulatory challenges with biosimilars: an update from 20 countries

Regulatory challenges with biosimilars: an update from 20 countries

Optimizing mesenchymal stem cell extracellular vesicles for chronic wound healing: Bioengineering, standardization, and safety

Biosimilars in the Era of Artificial Intelligence—International Regulations and the Use in Oncological Treatments

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