AAPS Journal最新文献_第5页

Recommendation for Clarifying FDA Policy in Evaluating "Sameness" of Higher Order Structure for Generic Peptide Therapeutics. 关于明确 FDA 在评估仿制肽治疗药物高阶结构 "相同性 "方面的政策的建议。

IF 5 3区医学

AAPS Journal Pub Date : 2024-11-26 DOI: 10.1208/s12248-024-00994-8

Jessica A Rogers-Crovak, Edward J Delaney, David J Detlefsen

{"title":"Recommendation for Clarifying FDA Policy in Evaluating \"Sameness\" of Higher Order Structure for Generic Peptide Therapeutics.","authors":"Jessica A Rogers-Crovak, Edward J Delaney, David J Detlefsen","doi":"10.1208/s12248-024-00994-8","DOIUrl":"https://doi.org/10.1208/s12248-024-00994-8","url":null,"abstract":"Recognizing the approach of a dramatic expansion of peptide therapeutics reaching the marketplace in recent years, led by GLP-1 receptor agonists such as semaglutide and liraglutide, the Center for Drug Evaluation and Research (CDER) branch of the US Food and Drug Administration (FDA) issued a final guidance in 2021 that was intended to assist generic drug producers in meeting Abbreviated New Drug Application (ANDA) obligations to establish \"sameness\" of their active peptide drug relative to that produced by innovator companies. Research and a published report by FDA scientists on best practices followed, which promulgated the use of nuclear magnetic resonance (NMR) and principal component analysis (PCA) and established a quantitative standard by which \"sameness\" of higher order structure for the applicant's peptide drug could be judged. A key requirement is that drug product samples be analyzed directly and non-invasively, a condition which in practice restricts sample modification to the addition of a small amount of deuterium oxide to allow signal lock and spectral data alignment (as required for NMR analysis). In the study described herein, data are presented to illustrate that 1) relatively small differences in sample pH can cause significant shifting of certain proton resonances, 2) that such resonance shifting is readily reversible and due to the degree of protonation of specific amino acid residues (rather than reflecting differences in higher order structure), and 3) that small differences in pH variability between sample cohorts can frequently cause failure to meet the quantitative benchmark established by the agency. Methodology is presented by which drug sample pHs can be aligned with minimal impact, and a recommendation is made that minor sample pH adjustments be allowed in assessing \"sameness\" of peptide drug higher order structure.","PeriodicalId":50934,"journal":{"name":"AAPS Journal","volume":"27 1","pages":"8"},"PeriodicalIF":5.0,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142717669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Tumor-Infiltration Mimicking Model of Contaminated Ovarian Tissue as an Innovative Platform for Advanced Cancer Research. 肿瘤浸润模拟受污染卵巢组织模型作为癌症高级研究的创新平台

IF 5 3区医学

AAPS Journal Pub Date : 2024-11-25 DOI: 10.1208/s12248-024-00997-5

Saeid Moghassemi, Arezoo Dadashzadeh, Carolina M Lucci, Christiani A Amorim

{"title":"Tumor-Infiltration Mimicking Model of Contaminated Ovarian Tissue as an Innovative Platform for Advanced Cancer Research.","authors":"Saeid Moghassemi, Arezoo Dadashzadeh, Carolina M Lucci, Christiani A Amorim","doi":"10.1208/s12248-024-00997-5","DOIUrl":"https://doi.org/10.1208/s12248-024-00997-5","url":null,"abstract":"The development of advanced preclinical models is crucial for the evaluation and validation of novel therapeutic strategies in oncology. Three-dimensional (3D) microtumor models, which incorporate both cancer and stromal cells within biomimetic hydrogels, have emerged as powerful tools that more accurately replicate the complex tumor microenvironment compared to traditional two-dimensional (2D) cell culture systems. In this context, our study aims to develop 3D microtumor models by integrating cancer and stromal cells within an extracellular-matrix-mimetic hydrogel, as a physiologically accurate microtumor model that can serve as an innovative platform for advanced cancer research and drug screening. Microtumors composed of varying ratios of leukemia cells (HL-60) to healthy ovarian stromal cells (SCs) (1:1, 1:10, 1:100, or 1:1000) were encapsulated in PEGylated fibrin hydrogel and cultured for 5 days. The proliferation and dynamics of cancerous and healthy cell populations were evaluated using CD43/Ki67 immunofluorescence double staining. Our findings indicate that tumor development and malignancy progression can be influenced by adjusting cell culture ratios and incubation time. Notably, the HL-60:SCs ratio of 1:100 closely replicated leukemia cell invasion in ovarian tissue, demonstrating detectable malignancy on the third and fifth days without significant changes in total cell density dynamics. This 3D leukemia microtumor model offers superior physiological relevance compared to traditional 2D in vitro assays and shows promising potential for applications in cellular analysis and drug screening.","PeriodicalId":50934,"journal":{"name":"AAPS Journal","volume":"27 1","pages":"7"},"PeriodicalIF":5.0,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142717674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Development of Solidified Self-microemulsifying Delivery Systems Containing Tacrolimus for Enhanced Dissolution and Pharmacokinetic Profile. 开发含有他克莫司的固化自微乳化给药系统，以提高溶解度和药代动力学特征。

IF 5 3区医学

AAPS Journal Pub Date : 2024-11-22 DOI: 10.1208/s12248-024-00992-w

Lingjun Zeng, Youye Wang, Zhihong Liu, Xiaomu Hu, Changqing Zheng, Lingyan Yao, Minxin Zhang, Xianquan Feng, Hongtao Song

{"title":"Development of Solidified Self-microemulsifying Delivery Systems Containing Tacrolimus for Enhanced Dissolution and Pharmacokinetic Profile.","authors":"Lingjun Zeng, Youye Wang, Zhihong Liu, Xiaomu Hu, Changqing Zheng, Lingyan Yao, Minxin Zhang, Xianquan Feng, Hongtao Song","doi":"10.1208/s12248-024-00992-w","DOIUrl":"https://doi.org/10.1208/s12248-024-00992-w","url":null,"abstract":"The use of tacrolimus (FK506) as an immunosuppressant is limited by its low aqueous solubility and bioavailability. The self-microemulsifying drug delivery system (SMEDDS) has successfully improved the solubility of FK506 in our previous study. This study focused on the solidification of liquid SMEDDS to capture the benefits of both liquid SMEDDS and solid dosage forms. Among several porous silica adsorbents evaluated, Aeroperl® 300 Pharma showed the best performance in terms of droplet size, in vitro dissolution, adsorbent-drug compatibility, and tabletabilities. And precoating the adsorbent with polyvinylpyrrolidone K30 resulted in complete drug release. Hydroxypropyl methylcellulose based matrix tablet was developed to achieve a sustained release of FK506. Differential scanning calorimetry and X-ray powder diffraction indicated that FK506 was present in a molecular or amorphous state in the solidified SMEDDS and tablets. In vivo pharmacokinetic studies showed that the self-prepared tablet had improved bioavailability (179.02%) compared to the marketed product Advagraf®. This study provided a promising candidate with improved dissolution and bioavailability for FK506 and a prospective platform for SMEDDS development.","PeriodicalId":50934,"journal":{"name":"AAPS Journal","volume":"27 1","pages":"6"},"PeriodicalIF":5.0,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Exploring the Correlation between LC-MS Multi-Attribute Method and Conventional Chromatographic Product Quality Assays through Multivariate Data Analysis. 通过多变量数据分析探索 LC-MS 多属性方法与传统色谱产品质量检测之间的相关性。

IF 5 3区医学

AAPS Journal Pub Date : 2024-11-21 DOI: 10.1208/s12248-024-00973-z

Tingting Jiang, Francis Kwofie, Nick Attanasio, Matthew Haas, John Higgins, Hari Kosanam

{"title":"Exploring the Correlation between LC-MS Multi-Attribute Method and Conventional Chromatographic Product Quality Assays through Multivariate Data Analysis.","authors":"Tingting Jiang, Francis Kwofie, Nick Attanasio, Matthew Haas, John Higgins, Hari Kosanam","doi":"10.1208/s12248-024-00973-z","DOIUrl":"https://doi.org/10.1208/s12248-024-00973-z","url":null,"abstract":"Biotherapeutics are subject to inherent heterogeneity due to the complex biomanufacturing processes. Numerous analytical techniques have been employed to identify, characterize, and monitor critical quality attributes (CQAs) to ensure product safety, and efficacy. Mass spectrometry (MS)-based multi-attribute method (MAM) has become increasingly popular in biopharmaceutical industry due to its potential to replace multiple traditional analytical methods. However, the correlation between MAM and conventional methods remains to be fully understood. Additionally, the complex analytical workflow and limited throughput of MAM restricts its implementation as a quality control (QC) release assay. Herein, we present a simple, robust, and rapid MAM workflow for monitoring CQAs. Our rapid approach allowed us to create a database from ~700 samples, including site-specific post-translational modifications (PTMs) quantitation results using MAM and data from traditional charge variant and oxidation characterization methods. To gain insights from this database, we employ multivariate data analysis (MVDA) to thoroughly exploit the data. By applying partial least squares regression (PLSR) models, we demonstrate the ability to quantitatively predict charge variants in ion exchange chromatography (IEX) assay and oxidation abundances in hydrophobic-interaction chromatography (HIC) assay using MAM data, highlighting the interconnectivity between MAM and traditional product quality assays. These findings help evaluate the suitability of MAM as a replacement for conventional methods for release, and more importantly, contribute to enhanced process and product understanding.","PeriodicalId":50934,"journal":{"name":"AAPS Journal","volume":"27 1","pages":"5"},"PeriodicalIF":5.0,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689539","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Precision Nanomedicine: Lapatinib-Loaded Chitosan-Gold Nanoparticles Targeting LINC01615 for Lung Cancer Therapy. 精准纳米医学：以 LINC01615 为靶点的拉帕替尼负载壳聚糖-金纳米粒子用于肺癌治疗

IF 5 3区医学

AAPS Journal Pub Date : 2024-11-19 DOI: 10.1208/s12248-024-00990-y

Hadi Rezaei Aghdam, Maryam Peymani, Ali Salehzadeh, Leila Rouhi, Atefeh Zarepour, Ali Zarrabi

{"title":"Precision Nanomedicine: Lapatinib-Loaded Chitosan-Gold Nanoparticles Targeting LINC01615 for Lung Cancer Therapy.","authors":"Hadi Rezaei Aghdam, Maryam Peymani, Ali Salehzadeh, Leila Rouhi, Atefeh Zarepour, Ali Zarrabi","doi":"10.1208/s12248-024-00990-y","DOIUrl":"https://doi.org/10.1208/s12248-024-00990-y","url":null,"abstract":"Long non-coding RNAs (lncRNAs) play essential roles as oncogenic factors in cancer progression by influencing cell proliferation, apoptosis, and metastasis pathways. This study aims to investigate the expression changes of LINC01615 in prevalent cancers, explore its correlation with patient mortality rates, and introduce a novel therapeutic approach to reduce LINC01615 expression. Using The Cancer Genome Atlas (TCGA) data, the expression changes of LINC01615 in various cancers were analyzed, and its relationship with patient survival rates through Cox regression analysis weas assessed. Co-expressed pathways related to LINC01615 were identified via network analysis. Potential drugs to decrease LINC01615 expression were identified using the GSE38376 study. Besides, chitosan-coated nanoparticles were fabricated and functionalized with the identified drug, Lapatinib, to examine their effect on lung cancer cell lines and changes in LINC01615 expression. Our results indicated elevated LINC01615 expression in various common cancers, particularly in lung cancer, which was associated with poor prognosis in lung, breast, and kidney cancers. Co-expression network analysis suggested links to metastasis-related genes. Lapatinib, identified through GEO data, was found to modulate LINC01615 expression effectively. Chitosan-gold nanoparticles conjugated with Lapatinib significantly reduced LINC01615 expression in lung cancer cell lines while enhancing apoptosis rates. Therefore, these nanoparticles could be considered a promising therapeutic candidate for treating cancers with overexpression of LINC01615.","PeriodicalId":50934,"journal":{"name":"AAPS Journal","volume":"27 1","pages":"4"},"PeriodicalIF":5.0,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142677782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A Data Driven Strategy for Implementation of Singlicate Analysis in Ligand Binding Assays Used for the Determination of Anti-drug Antibodies to a Multidomain Biotherapeutic. 在配体结合试验中实施多重分析的数据驱动策略，用于确定多域生物治疗药物的抗药抗体。

IF 5 3区医学

AAPS Journal Pub Date : 2024-11-19 DOI: 10.1208/s12248-024-00984-w

Susana Liu, Qiang Qu, Zhiping You, Gregory S Steeno, Charles Y Tan, Lisa A Dyleski, Ying Wang, Dan Baltrukonis

引用次数: 0

Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent. 在水滑石纳米载体中配制甘草酸，以作为肝脏保护剂。

IF 5 3区医学

AAPS Journal Pub Date : 2024-11-19 DOI: 10.1208/s12248-024-00986-8

Magali Hernández, Enrique Lima, Jonathan J Magaña, Adriana Ganem-Rondero

{"title":"Glycyrrhizic Acid Formulated in Hydrotalcite Nanocarriers Intended to Act as a Hepatoprotective Agent.","authors":"Magali Hernández, Enrique Lima, Jonathan J Magaña, Adriana Ganem-Rondero","doi":"10.1208/s12248-024-00986-8","DOIUrl":"https://doi.org/10.1208/s12248-024-00986-8","url":null,"abstract":"The article focuses on preparing a nanoformulation based on hydrotalcite and glycyrrhizic acid (GA), seeking a hepatoprotective effect. For this purpose, hydrotalcite-GA formulations were prepared by varying the following conditions to obtain optimal systems in terms of size and PDI (the lowest values), and Z potential (the highest values): (i) type of hydrotalcite (obtained by co-precipitation or calcined hydrotalcite); method used (ultrasound or high shear stirring), and (iii) type of stabilizer (Tween®80 or Pluronic® F-127). The best results were obtained using hydrotalcite obtained by co-precipitation, with high shear stirring and adding a stabilizer, either Tween®80 (HT-T80-GA: mean particle size = 315 nm, PDI = 0.18, Z potential = -20.93) or Pluronic® F-127 (HT-PF127-GA: mean particle size = 307 nm; PDI = 0.27, Z potential = -21.03). After stability studies, the HT-T80-GA formulation was chosen to study antioxidant activity, cytotoxicity, and intracellular penetration capacity. Although the hepatoprotective effect of GA in solution allowed a high viability and antioxidant activity, the fact of including GA in the HT-T80-GA formulation favored its penetration into hepatocytes, with a decrease in Caspase-3/7 expression of C-9 hepatocyte cells treated with H2O2, suggesting the capacity to inhibit apoptosis.","PeriodicalId":50934,"journal":{"name":"AAPS Journal","volume":"27 1","pages":"2"},"PeriodicalIF":5.0,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142677778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Possibilities and Limitations in Substituting anti-Drug Antibody Titers with Signal-to-Noise Ratios: A Comprehensive Comparison Using Two Clinical Trial Datasets of Adalimumab. 用信噪比替代抗药抗体滴度的可能性和局限性：使用阿达木单抗的两个临床试验数据集进行综合比较。

IF 5 3区医学

AAPS Journal Pub Date : 2024-11-19 DOI: 10.1208/s12248-024-00991-x

Dawon Jang, Jaeil Kim, Youngwon Jo, Hyuna Lee, Ahra Go, Jieun Kim, Soyoung Choi

{"title":"Possibilities and Limitations in Substituting anti-Drug Antibody Titers with Signal-to-Noise Ratios: A Comprehensive Comparison Using Two Clinical Trial Datasets of Adalimumab.","authors":"Dawon Jang, Jaeil Kim, Youngwon Jo, Hyuna Lee, Ahra Go, Jieun Kim, Soyoung Choi","doi":"10.1208/s12248-024-00991-x","DOIUrl":"https://doi.org/10.1208/s12248-024-00991-x","url":null,"abstract":"Immunogenicity assessment is vital in clinical trials and is measured through a multi-tiered approach (screening, confirmatory and titer assays). However, recent studies have suggested that titer results could be reported from ADA signal-to-noise ratios (S/N ratios=sample mean signal/negative control mean signal). More data analysis using two clinical trials of adalimumab: SB5-1003 (single-dose, healthy participants) and SB5-4001 (multiple-dose, interchangeability study, patients with plaque psoriasis), therefore, is indispensable whether substituting ADA S/N ratio as an alternative way of reporting titer results has no impact on interpretation on clinical outcome. In this study, we demonstrated that there is a strong correlation between S/N ratios and titers and no impact on overall PK results. Nonetheless, sub-analyses with time or adalimumab level showed a change in the regression between S/N ratios and titers, leading to different titer values from the same S/N ratio. These data demonstrate that S/N ratios may fully replace titers in limited circumstances such as a biosimilar study which goal is to prove equivalence between the originator and candidate product, but need a caution in other cases.","PeriodicalId":50934,"journal":{"name":"AAPS Journal","volume":"27 1","pages":"3"},"PeriodicalIF":5.0,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142677780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Erectile Dysfunction Therapy of Bariatric Patients: Tadalafil Biopharmaceutics and Pharmacokinetics Before vs. After Gastric Sleeve/Bypass. 减肥患者的勃起功能障碍治疗：胃袖套术/胃旁路术前与胃袖套术/胃旁路术后的他达拉非生物药理和药代动力学。

IF 5 3区医学

AAPS Journal Pub Date : 2024-11-14 DOI: 10.1208/s12248-024-00985-9

Daniel Porat, Oleg Dukhno, Sandra Cvijić, Arik Dahan

{"title":"Erectile Dysfunction Therapy of Bariatric Patients: Tadalafil Biopharmaceutics and Pharmacokinetics Before vs. After Gastric Sleeve/Bypass.","authors":"Daniel Porat, Oleg Dukhno, Sandra Cvijić, Arik Dahan","doi":"10.1208/s12248-024-00985-9","DOIUrl":"10.1208/s12248-024-00985-9","url":null,"abstract":"Bariatric surgery introduces significant changes in the gastrointestinal tract, which may affect oral drug absorption/bioavailability. Here we investigate the phosphodiesterase-5 inhibitor (PDE5i) tadalafil for potentially impaired post-bariatric solubility/dissolution and absorption. Solubility was studied in vitro in different pHs, and ex vivo in gastric content aspirated from patients pre/post-surgery. Dissolution was studied in conditions mimicking pre/post-surgery stomach. Finally, the experimental data were used in physiologically-based pharmacokinetic (PBPK) model (GastroPlus®) to simulate pre- vs. post-surgery tadalafil PK. Tadalafil demonstrated low and pH-independent solubility, both in vitro and ex vivo. Tadalafil release from all drug products and under all gastric conditions was incomplete, with particularly poor dissolution (2%) of the highest dose under post-bariatric conditions. PBPK simulations revealed altered tadalafil PK after gastric bypass-but not after sleeve gastrectomy-compared to unoperated individuals, with 44-48% decreased Cmax, 35-56% decreased AUC and 44% shorter Tmax. This mechanistic analysis suggests that tadalafil may be as effective after sleeve gastrectomy as before the procedure; meanwhile, results after gastric bypass raise concerns regarding the bioperformance of the drug. In addition, the drug's duration of action may be much shorter after gastric bypass. Thus, the effectiveness of tadalafil, widely regarded as the 'weekend pill', may be shorter than expected among gastric bypass patients.","PeriodicalId":50934,"journal":{"name":"AAPS Journal","volume":"26 6","pages":"114"},"PeriodicalIF":5.0,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142631798","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009-2023. 日本仿制药和生物仿制药监管审批趋势分析：PMDA 在 2009-2023 财年的 15 年间。

IF 5 3区医学

AAPS Journal Pub Date : 2024-11-12 DOI: 10.1208/s12248-024-00989-5

Ryosuke Kuribayashi, Kanoko Goto, Takumi Ogawa

{"title":"Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009-2023.","authors":"Ryosuke Kuribayashi, Kanoko Goto, Takumi Ogawa","doi":"10.1208/s12248-024-00989-5","DOIUrl":"10.1208/s12248-024-00989-5","url":null,"abstract":"Generics and biosimilars play an important role in sustaining the universal healthcare insurance systems in Japan. The Pharmaceuticals and Medical Devices Agency (PMDA) reviews the quality, efficacy, and safety of generics and biosimilars for marketing authorization in Japan. Trend analyses of generics and biosimilars in terms of regulatory science have rarely been published. The PMDA and National Institute of Health Sciences websites were verified for generics and biosimilars, and information related to guidelines and notifications and the number of newly approved generics and biosimilars for fiscal year (FY) 2009-2023 were compiled. Approximately 1,900 and 200 generic drug products were approved in Japan in FY 2010 and 2023, respectively. The number of approved generic drug products has gradually decreased to one-tenth in the past 15 years. Overall, 35 biosimilars were approved in FY 2009-2023. The number of approved biosimilars has increased since FY 2017. This article reported a trend analysis of generics and biosimilars in terms of guidelines, notifications, and the number of applied and approved drug products in FY 2009-2023. Our primary goal is to increase patient access to affordable generics and biosimilars with assurance in appropriate quality.","PeriodicalId":50934,"journal":{"name":"AAPS Journal","volume":"26 6","pages":"113"},"PeriodicalIF":5.0,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142631824","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0