The role of the quality assessment in the determination of overall biosimilarity: A simulated case study exercise

Schiestl, Martin; Li, Jing; Abas, Arpah; Vallin, Antonio; Millband, Jennifer; Gao, Kai; Joung, Jeewon; Pluschkell, Stefanie; Go, Thomas; Kang, Hye‐Na

doi:10.1016/j.biologicals.2013.11.009

Cited by 25 publications

(11 citation statements)

References 9 publications

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“…As illustrated in the previous workshop [21], a careful and stepwise development approach with SBP candidates is essential in undertaking a continuous assessment of risks and residual uncertainties arising from structural and functional comparability studies and resolving these uncertainties prior to making the "Go" decision for clinical studies. Since clinical comparability studies are inherently limited and imperfect in detecting the impact of even minor structural or functional differences, an effort should be made in increasing the study sensitivity and homogeneity in order to determine the extent of their clinical relevance.…”

Section: Discussionmentioning

confidence: 99%

Case studies on clinical evaluation of biosimilar monoclonal antibody: Scientific considerations for regulatory approval

et al. 2015

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Section: Discussionmentioning

confidence: 99%

Case studies on clinical evaluation of biosimilar monoclonal antibody: Scientific considerations for regulatory approval

et al. 2015

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“…These analytical data serve as the foundation of the overall comparability exercise and totality-of-the-evidence concept 24 . Next, preclinical properties (i.e.…”

Section: Biosimilar Developmentmentioning

confidence: 99%

The totality-of-the-evidence approach to the development and assessment of GP2015, a proposed etanercept biosimilar

Strand

Girolomoni

Schiestl³

et al. 2017

Current Medical Research and Opinion

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Objective: The aim of this review is to describe the inherent variability that is natural to biologics and, using the proposed etanercept biosimilar (GP2015) as an example, provide details on the "totality-ofthe-evidence" concept, whereby all physicochemical, biologic, preclinical, and clinical data for a biosimilar and reference medicine are evaluated in an iterative, stepwise manner and shown to be highly similar. Methods: This review was carried out by a search of published articles, reviews, abstracts and patents in PubMed/Medline and Google Scholar up to November 2016. Results: Analytical, functional, preclinical, and clinical data provide a comprehensive understanding of both GP2015 and reference etanercept, and demonstrate a high level of similarity between the two products in accordance with regulatory requirements. The totality of the evidence from all analyses and performed trials provides a robust scientific bridge between the biosimilar and clinical experience with the reference medicine, and is used to justify the use of the biosimilar in all indications for which the reference medicine is approved. Conclusion: Biologic therapies have revolutionized the treatment of immune-mediated inflammatory diseases. The availability of biosimilars has the potential to improve patient access to biologic medicines and stimulate innovation. Physicians may be unfamiliar with the totality-of-the-evidence concept; therefore education and information on this unique approach to developing biosimilars is required to facilitate the use of biosimilars in clinical practice and allow physicians to make informed treatment decisions. ARTICLE HISTORY

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“…The WHO is facilitating that process by organizing implementation workshops with lectures, case studies, and reviews of examples that serve as opportunities to discuss scientific as well as practical aspects in a forum of regulators, manufacturers, and academia. The key lectures, outcomes of the discussions, and reports from countries have been published (28 articles in a special issue of Biologicals ( 39 , 2011)), including very useful case studies (Table ). These discussions indicate considerable convergence in approach to biosimilars but also, where national guidelines on biosimilars have been developed, highlight some differences in details between jurisdictions.…”

Section: Challenges Imposed By the Arrival Of Similar Biotherapeutic mentioning

confidence: 99%

WHO standards for biotherapeutics, including biosimilars: an example of the evaluation of complex biological products

Knežević

Griffiths²

2017

Annals of the New York Academy of Sciences

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The most advanced regulatory processes for complex biological products have been put in place in many countries to provide appropriate regulatory oversight of biotherapeutic products in general, and similar biotherapeutics in particular. This process is still ongoing and requires regular updates to national regulatory requirements in line with scientific developments and up-to-date standards. For this purpose, strong knowledge of and expertise in evaluating biotherapeutics in general and similar biotherapeutic products, also called biosimilars, in particular is essential. Here, we discuss the World Health Organization's international standard-setting role in the regulatory evaluation of recombinant DNA-derived biotherapeutic products, including biosimilars, and provide examples that may serve as models for moving forward with nonbiological complex medicinal products. A number of scientific challenges and regulatory considerations imposed by the advent of biosimilars are described, together with the lessons learned, to stimulate future discussions on this topic. In addition, the experiences of facilitating the implementation of guiding principles for evaluation of similar biotherapeutic products into regulatory and manufacturers' practices in various countries over the past 10 years are briefly explained, with the aim of promoting further developments and regulatory convergence of complex biological and nonbiological products.

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The role of the quality assessment in the determination of overall biosimilarity: A simulated case study exercise

Cited by 25 publications

References 9 publications

Case studies on clinical evaluation of biosimilar monoclonal antibody: Scientific considerations for regulatory approval

Case studies on clinical evaluation of biosimilar monoclonal antibody: Scientific considerations for regulatory approval

The totality-of-the-evidence approach to the development and assessment of GP2015, a proposed etanercept biosimilar

WHO standards for biotherapeutics, including biosimilars: an example of the evaluation of complex biological products

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