Quality, safety and efficacy of follow-on biologics in Japan

Yamaguchi, Teruhide; Arato, Teruyo

doi:10.1016/j.biologicals.2011.06.015

Cited by 23 publications

(24 citation statements)

References 2 publications

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“…As noted by Yamaguchi and colleagues, 3 and in the country-by-country descriptions of regulatory requirements included in table 1 of our Review, 1 Japan’s PDMA requires that sponsors show similarity between a biosimilar candidate and the reference product through clinical and non-clinical studies, and structural and functional analyses. However, in some instances, formal comparative efficacy studies might not be required.…”

mentioning

confidence: 86%

“…The English-language literature published before our Review’s cutoff point of Oct 30, 2014, for our review identified epoetin as the only biosimilar that had received regulatory approval from Japan’s Pharmaceuticals and Medical Device Agency (PDMA); however, as noted by Nagai and colleagues, epoetin was not approved for indications related to chemotherapy. 2,3 English-language descriptions of subsequently approved oncology biosimilars in Japan (all filgrastims) were published after our literature cutoff. 4 Somatotropin received PDMA approval in 2009; however, it is not an oncology biosimilar.…”

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confidence: 99%

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Japanese regulatory authority's perspective on biosimilars – Authors' reply

Bennett

Chen

Hermanson

et al. 2015

The Lancet Oncology

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confidence: 86%

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confidence: 99%

Japanese regulatory authority's perspective on biosimilars – Authors' reply

Bennett

Chen

Hermanson

et al. 2015

The Lancet Oncology

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“…In 2010, PDMA approved a biosimilar epoetin, although its indication does not include oncology; no oncology biosimilar has yet received PDMA approval. 29 …”

Section: Regulationsmentioning

confidence: 99%

Regulatory and clinical considerations for biosimilar oncology drugs

Bennett

Chen

Hermanson

et al. 2014

The Lancet Oncology

103

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Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents—molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs—provide opportunities both to improve healthcare access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns.

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“…The necessary tests can cover quality, pharmacology, toxicity, pharmacokinetic, pharmacodynamic, and clinical safety (e.g. immunogenicity) and effi cacy [5].…”

Section: Generic Drugs and Biosimilarsmentioning

confidence: 99%

“…The necessary tests can cover quality, pharmacology, toxicity, pharmacokinetic, pharmacodynamic, and clinical safety (e.g. immunogenicity) and effi cacy [5].Until Spring 2012, MHLW/PMDA has approved two biosimilars: somatropin and epoetin alpha, both in 2009 [6][7][8]. …”

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confidence: 99%

PMDA update: the current situation and future directions

Ando¹

2013

GaBI J

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The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese drug regulatory agency, sharing responsibilities with the Ministry of Health, Labour and Welfare. Its mission is to protect the public health by assuring safety, effi cacy and quality of pharmaceuticals and medical devices. This paper introduces PMDA's current situation (until spring 2012) including its organisational structure, status of product review and safety measures, regulatory science, and international activities.Keywords: Approval review, international strategy, Japanese regulatory authority, PMDA, regulatory science, safety measure IntroductionThe Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's drug regulatory agency whose mission is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. This paper summarizes the structure and activities of the PMDA, including the setting up of a new Offi ce of Standards and Guidelines Development, the Science Board and the Offi ce of Review Innovation.Recent changes at PMDA have enabled the organisation to shorten the review time for both priority-and standard-review products, and decrease the 'drug lag', or time difference between Japan and the US for new drug approval. The latter has been achieved mostly through speeding up the post-application review process. Efforts are also continuing to speed up the application process such as by offering advice to start-ups and academics with promising candidate medical products on how to gather the data necessary for a complete application.The requirements for approval application of biosimilars are summarized in the guidelines on the 'Quality, safety and efficacy assurance of biosimilars' issued by the country's Ministry of Health, Labour and Welfare (MHLW). Two biosimilars have been approved in Japan by 2009.With regard to safety, PMDA is expanding its source of adverse drug reactions (ADR) information by utilizing electronic databases on insurance claims and medical records. PMDA also operates a Japanese language email messaging system for healthcare professionals carrying information on the safety of medical products.Bearing in mind the globalization of development, manufacture, distribution and consumption of medical products, PMDA is taking steps to enhance its international activities, including cooperation across Asia and international harmonization of regulatory standards, according to its international vision. OrganizationPMDA has 678 regular staff as of 1 April 2012, having increased the number of reviewers and safety information analysts in order to better fulfi ll its mission. PMDA established its Science Board as a high-level body to provide PMDA reviewers with scientifi c advice on assessing the products of advanced technologies and science, in close collaboration with leading academic researchers. The Board consists of external experts who are active in the frontlines of medical, dental, pharmaceutical, and engineering research [1].In order to liaise well with the Science Boar...

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Quality, safety and efficacy of follow-on biologics in Japan

Cited by 23 publications

References 2 publications

Japanese regulatory authority's perspective on biosimilars – Authors' reply

Japanese regulatory authority's perspective on biosimilars – Authors' reply

Regulatory and clinical considerations for biosimilar oncology drugs

PMDA update: the current situation and future directions

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