Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada

Kuribayashi, Ryosuke; Appleton, Scott

doi:10.1007/s40268-017-0186-8

Cited by 5 publications

(8 citation statements)

References 4 publications

(8 reference statements)

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“…GD utilisation varies among countries, especially with the effect of different government policies. The share of GDs ranges from 17% to 83% across Europe, 84% in the USA, 68.6% in Canada and 56.2% in Japan 22,23 . This sales volume was reported to vary between 53.6% and 56.6% in Turkey with an increasing trend but still behind that of many OECD countries 24,25 .…”

Section: Discussionmentioning

confidence: 99%

“…The share of GDs ranges from 17% to 83% across Europe, 84% in the USA, 68.6% in Canada and 56.2% in Japan. 22,23 This sales volume was reported to vary between 53.6% and 56.6% in Turkey with an increasing trend but still behind that of many OECD countries. 24,25 This increasing trend across the country seems to be compatible with GD use in primary care in our study.…”

Section: Discussionmentioning

confidence: 99%

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Generic drug prescribing in primary care: A nationwide analysis

et al. 2021

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The generic drug (GD) contains the active substance(s) with the same qualitative and quantitative composition as the reference drug and has the same/similar pharmaceutical form. For market approval, a candidate GD only requires demonstration of bioequivalence to the reference drug after patent expiration. No repetition of preclinical and clinical phase trials usually allows for cheaper pricing with the same therapeutic effect. 1 In fact, the price of GDs is reported as 20%-90% less than that of the reference drugs before the patent expires. 2 Therefore, disseminating GD use has been accepted as an effective approach to control increasing drug expenditures. 3 Furthermore, this provides significant savings on healthcare costs and contributes to the long-term sustainability of healthcare. 1,4 It has been consistently shown that the effectiveness and safety of drugs do not differ between generic and reference preparations. [5][6][7][8] Despite a huge evidence base, physicians, other healthcare professionals and patients were often reported to have various

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Generic drug prescribing in primary care: A nationwide analysis

et al. 2021

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“…27,28 The Pharmaceutical and Medical Devices Agency (PMDA, Japan) and Health Canada (Canada) recommend the weight-of-evidence approach incorporating in vitro, PK, and PD study to demonstrate BE. 26,[29][30][31] The FDA continues to explore and evaluate new methods to make development and BE assessment of OIDPs more cost-and time-efficient. 23 Alternative BE approaches to the comparative clinical endpoint BE study should be designed to account for the different steps and factors impacting local delivery of the active ingredient(s) to the site of action.…”

Section: General Remarksmentioning

confidence: 99%

“…In comparison with the FDA’s aggregate weight‐of‐evidence approach, the European Medical Agency (EMA) recommends a stepwise therapeutic equivalence approach, including in vitro studies (step 1), PK studies (step 2), and PD and clinical safety/efficacy studies (step 3) 27,28 . The Pharmaceutical and Medical Devices Agency (PMDA, Japan) and Health Canada (Canada) recommend the weight‐of‐evidence approach incorporating in vitro , PK, and PD study to demonstrate BE 26,29–31 …”

Section: Potential Approaches and Explored Endpoints To Address The C...mentioning

confidence: 99%

Considerations for the Forced Expiratory Volume in 1 Second‐Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products

Lee

Feng

Conti

et al. 2022

Clin Pharma and Therapeutics

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Herein, we present the US Food and Drug Administration (FDA) Office of Research and Standards’ current thinking, challenges, and opportunities for comparative clinical endpoint bioequivalence (BE) studies of orally inhaled drug products (OIDPs). Given the product‐associated complexities of OIDPs, the FDA currently uses an aggregate weight‐of‐evidence approach to demonstrate that a generic OIDP is bioequivalent to its reference listed drug. The approach utilizes comparative clinical endpoint BE or pharmacodynamic BE studies, pharmacokinetic BE studies, and in vitro BE studies to demonstrate equivalence, in addition to formulation sameness and device similarity. For the comparative clinical endpoint BE studies, metrics based on forced expiratory volume in the first second (FEV1) are often the recommended clinical endpoints. However, the use of FEV1 can pose a challenge due to its large variability and a relatively flat dose‐response relationship for most OIDPs. The utility of applying dose‐scale analysis was also investigated by the FDA but often not recommended, due to either flat dose‐response relationships or insufficient clinical study data. As a potential way to reduce sample size, we found adapting covariate analysis only explained a limited portion of the variation based on further investigation. The FDA continues to develop alternative methods to make BE assessment of OIDPs more cost‐ and time‐efficient. Prospective generic drug applicants and academia are encouraged to participate in this effort by proposing new approaches in pre‐abbreviated new drug application meeting requests and collaborating in the form of grants and contracts under the Generic Drug User Fee Amendments (GDUFA) Regulatory Science and Research Program.

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“…Generic drugs play an important role in sustaining the modern healthcare system, because escalating healthcare and drug costs are becoming a growing problem worldwide [ 1 ]. Healthcare costs in Japan have been escalating since the 1960s, presumably due to the establishment of the universal health insurance system and the subsequent increase in the number of patients receiving medical care, as well as the rapid aging of the population [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

Generic Drug Usage in Dentistry across Japan: Analysis Using a Japanese National Database

Ono

Komatsuzaki

Iguchi

et al. 2021

IJERPH

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The aim of this study was to identify regional disparities in generic drug usage and to examine related factors. The database used for the analysis was the 2018 national health insurance claims data published on the Japanese Ministry of Health, Labour, and Welfare. The drugs that were targeted were a combination of brand-name and generic tetracycline ointments for periodontal treatment and lidocaine injection solution used for dental anesthesia. The usage of generic drugs was calculated and compared by prefecture based on the number of health insurance claims. The comparison of related factors was conducted using data from other national statistical survey. The results showed that the mean generic drug usage of tetracycline for periodontal treatment in all prefectures was 71.2 ± 8.1%, ranging from 45.8% to 85.3%. The mean generic lidocaine used for dental anesthesia was 47.6 ± 10.0%, ranging from 30.5% to 66.2%. The rank correlation coefficient between the two was 0.359 (p < 0.05), and the tendency of using both generic drugs was low in major metropolitan areas. Generic drug usage in Japan is low; thus, in order to reduce healthcare costs, generic drugs need to be actively used in dentistry.

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Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada

Cited by 5 publications

References 4 publications

Generic drug prescribing in primary care: A nationwide analysis

Generic drug prescribing in primary care: A nationwide analysis

Considerations for the Forced Expiratory Volume in 1 Second‐Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products

Generic Drug Usage in Dentistry across Japan: Analysis Using a Japanese National Database

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