Expert Opinion on Biological Therapy最新文献_第6页

Relative bioavailability, immunogenicity, and safety of two adalimumab-adbm formulations in healthy volunteers: a double-blind, randomized, single-dose, parallel-arm Phase I trial (VOLTAIRE-HCLF). 健康志愿者体内两种阿达木单抗-adbm制剂的相对生物利用度、免疫原性和安全性：双盲、随机、单剂量、平行臂 I 期试验。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-05-19 DOI: 10.1080/14712598.2024.2354902

Viktoria Moschetti, Susanne Buschke, Julia Bertulis, Kathrin Hohl, Dorothy McCabe

{"title":"Relative bioavailability, immunogenicity, and safety of two adalimumab-adbm formulations in healthy volunteers: a double-blind, randomized, single-dose, parallel-arm Phase I trial (VOLTAIRE-HCLF).","authors":"Viktoria Moschetti, Susanne Buschke, Julia Bertulis, Kathrin Hohl, Dorothy McCabe","doi":"10.1080/14712598.2024.2354902","DOIUrl":"10.1080/14712598.2024.2354902","url":null,"abstract":"Objective: VOLTAIRE-HCLF compared the relative bioavailability of citrate-free high-concentration and reference formulations of the biosimilar adalimumab-adbm (Cyltezo®), including pharmacokinetic (PK) profiles, immunogenicity, and safety profiles in healthy volunteers.Methods: Healthy volunteers (N = 200) aged 18-55 years and with body mass index of 18.5-29.9 kg/m2 and no prior exposure to adalimumab were randomized in a 1:1 ratio to receive a single subcutaneous injection of either adalimumab-adbm 40 mg/0.4 mL (high-concentration formulation) or 40 mg/0.8 mL (reference formulation). Participants completed 13 follow-up visits over 57 days, followed by a safety follow-up period of up to 70 days.Results: The main PK parameters were similar for the high-concentration and reference groups. For all primary endpoints, the geometric mean ratios and 90% confidence intervals of AUC0-1344, AUC0-∞, and Cmax for both groups were entirely within the standard 80-125% bioequivalence acceptance range at 101.88% (93.31-111.23%), 105.38% (95.06-116.81%), and 91.29% (84.38-98.76%), respectively. There were no differences in the proportion of anti-drug antibody-positive participants or in the distribution of anti-drug antibody titers between the two formulations at any time point after drug dosing. Participants who were given the high-concentration formulation of adalimumab-adbm experienced a lower incidence of adverse events and local reactions than those who were given the reference formulation.Conclusions: Overall, the high-concentration and reference adalimumab-adbm formulations had highly similar PK and immunogenicity profiles and were safe and well tolerated.Clinical trial registration: NCT05203289.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140912027","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

Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis. 从行业角度看监管机构（RA）对生物仿制药申请的质量审查--通过深入的查询分析，评估监管机构对化学、制造和控制信息的指导和期望。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-07-04 DOI: 10.1080/14712598.2024.2376197

Heather Rae Hufnagel, Scott D Tennyson

{"title":"Industry perspective on regulatory authority (RA) quality reviews of biosimilar applications - an evaluation of RA guidance and expectations for chemical, manufacturing, and controls information through in-depth query analysis.","authors":"Heather Rae Hufnagel, Scott D Tennyson","doi":"10.1080/14712598.2024.2376197","DOIUrl":"10.1080/14712598.2024.2376197","url":null,"abstract":"Purpose: Evaluate the type and quantity of quality information (i.e. Chemistry, Manufacturing, and Control) requested by the US FDA and EMA in queries pertaining to biosimilar applications.Methods: Numbers/types of queries received following regulatory submissions (FDA/EMA, n = 7/n = 5) for seven biosimilars (PF-filgrastim [Nivestym], PF-rituximab [Ruxience®], PF-trastuzumab [Trazimera®], PF-bevacizumab [Zirabev®], PF-pegfilgrastim [Nyvepria®], PF-adalimumab [Abrilada™/Amsparity®], PF-infliximab [Ixifi]) from a single product portfolio were analyzed considering published regulatory authority (RA) guidance and in relation to sections/subsections of Module 3: Quality from the Common Technical Document regulatory dossier and topics based on keyword assignment.Results: Queries were most frequently assigned (FDA/EMA %, range) to Drug Substance Manufacture (subsection 3.2.S.2; 21-35%/13-50%), Control of Drug Substance (3.2.S.4; 3-11%/5-17%), Drug Product Pharmaceutical Development (3.2.P.2; 1-12%/1-15%) and Manufacture (3.2.P.3; 17-41%/2-13%), and Analytical Similarity (3.2.R; 4-21%/4-20%). The proportion of Drug Substance and Drug Product queries was significantly different between RAs (n1 = 952, n2 = 468, p-value <0.001; two-sample proportion z-test). Topic assignments included: Control (12-27%/12-28%), Manufacturing (56-72%/34-66%), Stability (1-12%/2-24%), Biosimilarity (5-16%/5-25%), and Container Closure (0-3%/0-9%).Conclusion: The focus of both RAs on topics related to manufacturing and controls is valuable in understanding expectations for scientific and technical content related to gaining biosimilar approval.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141497535","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

Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease. 系统综述：炎症性肠病患者在原研英夫利昔单抗和生物仿制药英夫利昔单抗之间转换的有效性和安全性。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-07-18 DOI: 10.1080/14712598.2024.2378090

Gary R Lichtenstein, Arif Soonasra, Mark Latymer, Sheena Singh, Brian G Feagan

{"title":"Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease.","authors":"Gary R Lichtenstein, Arif Soonasra, Mark Latymer, Sheena Singh, Brian G Feagan","doi":"10.1080/14712598.2024.2378090","DOIUrl":"10.1080/14712598.2024.2378090","url":null,"abstract":"Introduction: Infliximab (IFX) biosimilars are available to treat inflammatory bowel disease (IBD), offering cost reductions versus originator IFX in some jurisdictions. However, concerns remain regarding the efficacy and safety of originator-to-biosimilar switching. This systematic literature review evaluated safety and effectiveness of switching between IFX products in patients with IBD, including multiple switchers.Methods: Embase, PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials were searched to capture studies (2012-2022) including patients with IBD who switched between approved IFX products. Effectiveness outcomes: disease activity; disease severity; response to treatment; patient-reported outcomes (PROs). Safety outcomes: incidence and rate of adverse events (AEs); discontinuations due to AEs, failure rate; hospitalizations; surgeries. Immunogenicity outcomes (n, %): anti-drug antibodies; patients receiving concomitant immunomodulatory medication.Results: Data from 85 publications (81 observational, two randomized controlled trials) were included. Clinical effectiveness outcomes were consistent with the known profile of originator IFX with no difference after switching. There were no unexpected/serious AEs after switching, and rates of AEs were generally consistent with the known profile of IFX.Conclusions: Most studies reported that clinical, PROs, and safety outcomes for originator-to-biosimilar switching were clinically equivalent to originator responses. Limited data are available regarding multiple switches.Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42021289144.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141558386","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

Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis. 一项多中心随机、双盲、安慰剂对照研究，旨在评估地诺单抗生物类似物 MW031 在中国绝经后骨质疏松症妇女中的疗效和安全性。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-05-16 DOI: 10.1080/14712598.2024.2352587

Yan Jiang, Yanan Huo, Yufeng Li, Xijian Kong, Bingwu Wang, Feng Liu, Xin Zheng, Yukun Li, Yunfa Yang, Yongsheng Xu, Qingyun Xue, Zhitian Hu, Yanfeng Xiao, Wen Ma, Yinhan Guo, Wei Yu, Weibo Xia

{"title":"Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis.","authors":"Yan Jiang, Yanan Huo, Yufeng Li, Xijian Kong, Bingwu Wang, Feng Liu, Xin Zheng, Yukun Li, Yunfa Yang, Yongsheng Xu, Qingyun Xue, Zhitian Hu, Yanfeng Xiao, Wen Ma, Yinhan Guo, Wei Yu, Weibo Xia","doi":"10.1080/14712598.2024.2352587","DOIUrl":"10.1080/14712598.2024.2352587","url":null,"abstract":"Background: This study aimed to assess the efficacy and safety of MW031 in Chinese postmenopausal women with osteoporosis.Patients and methods: In this randomized, double-blind, placebo-controlled, multicenter clinical trial, 448 postmenopausal women with osteoporosis were randomized 3:1 to receive MW031 and placebo for 12 months. The primary efficacy endpoint was the percentage change from baseline in BMD at lumbar spine in month 12. The safety and immunogenicity profiles were also included.Results: Of 448 randomized patients, 421 completed the study (MW031, n = 322; placebo, n = 99).After 12 months of MW031 treatment, BMD increased by 5.80% at lumbar spine,3.65% at total hip, and 2.93% at femoral neck. The model-adjusted difference was 3.86% (P<0.0001), 2.34% (P<0.0001), and 1.05% (p = 0.08) compared with placebo group, respectively. For the bone turnover markers, serum CTX level in MW031 group decreased to the maximum difference in month 1 (-71.71%, 95% CI: -77.83%, -65.60%, P<0.0001) compared with the placebo group. The safety analysis showed no significant differences in the proportion of patients reporting any adverse events between the two groups.Conclusion: This study demonstrated that MW031 safely and effectively increased BMD and rapidly decreased the level of bone resorption marker in Chinese postmenopausal women with osteoporosis.Trial registration: NCT05215977 (ClinicalTrials.gov.).","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140944357","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 randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males. 一项随机、双盲、单剂量的 1 期研究，比较了健康男性服用地诺单抗生物仿制药 CT-P41 和参考药物地诺单抗的药代动力学、药效学、安全性和免疫原性。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-02-22 DOI: 10.1080/14712598.2024.2316846

Anhye Kim, Jang Hee Hong, Wonsuk Shin, Hyounggyoon Yoo, Jin-Gyu Jung, Jean-Yves Reginster, SungHyun Kim, YunJu Bae, JeeHye Suh, Sera Kim, EunKyung Lee, Stuart Silverman

{"title":"A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males.","authors":"Anhye Kim, Jang Hee Hong, Wonsuk Shin, Hyounggyoon Yoo, Jin-Gyu Jung, Jean-Yves Reginster, SungHyun Kim, YunJu Bae, JeeHye Suh, Sera Kim, EunKyung Lee, Stuart Silverman","doi":"10.1080/14712598.2024.2316846","DOIUrl":"10.1080/14712598.2024.2316846","url":null,"abstract":"Background: This study's objective was to demonstrate pharmacokinetic (PK) similarity and safety of denosumab biosimilar, CT‑P41, and United States-licensed reference denosumab (US-denosumab) in healthy male Asian adults, considering also pharmacodynamic (PD) outcomes.Research design and methods: This double-blind, two-arm, parallel-group, Phase 1 study randomized (1:1) healthy males to a single (60-mg) subcutaneous dose of CT‑P41 or US-denosumab. Primary endpoints were area under the concentration - time curve (AUC) from time zero to infinity (AUC0-inf), AUC from time zero to the last quantifiable concentration (AUC0-last), and maximum serum concentration (Cmax). PK equivalence was determined if 90% confidence intervals (CIs) for ratios of geometric least-squares means (gLSMs) were within the predefined 80-125% equivalence margin. Secondary PK, PD, safety, and immunogenicity outcomes were also evaluated.Results: Of 154 participants randomized (76 CT‑P41; 78 US-denosumab), 151 received study drug (74 CT‑P41; 77 US-denosumab). Primary and secondary PK results, PD results, safety, and immunogenicity were comparable between groups. Ninety percent CIs for ratios of gLSMs were within the predefined equivalence margin for AUC0-inf (100.4-114.7), AUC0-last (99.9-114.3), and Cmax (95.2-107.3).Conclusions: Following a single dose in healthy males, CT‑P41 demonstrated PK equivalence with US-denosumab.Trial registration: ClinicalTrials.gov: NCT06037395.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139722193","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

Overview of biosimilar medicines in Spain: market dynamics, policies, evidence-based insights and avenues for a sustainable market. 西班牙生物仿制药概览：市场动态、政策、循证见解和可持续市场的途径。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-06-06 DOI: 10.1080/14712598.2024.2363229

Isabel Río-Álvarez, Encarnación Cruz-Martos

{"title":"Overview of biosimilar medicines in Spain: market dynamics, policies, evidence-based insights and avenues for a sustainable market.","authors":"Isabel Río-Álvarez, Encarnación Cruz-Martos","doi":"10.1080/14712598.2024.2363229","DOIUrl":"10.1080/14712598.2024.2363229","url":null,"abstract":"Introduction: After 17 years on the market, biosimilar medicines have contributed significantly to the sustainability of healthcare in Spain, providing cost-effective treatment options and savings of more than €1 billion by 2022 alone. To fully exploit this potential and meet the European pharmaceutical strategy's objectives of increased access and a resilient supply chain, Member States need to optimize their biosimilars policies.Areas covered: We conducted an exhaustive review of biosimilar medicines in Spain, first describing their regulatory framework. Biosimilar policies at both national and regional level have been collected and updated figures on the biosimilars market are provided based on official data. Knowledge and acceptance of biosimilar medicines among patients and medical societies based on biosimilar positioning documents is reviewed. National evidence on the contribution of biosimilars to savings and sustainability is also included in this study.Expert opinion: In Spain, there is a need to further build confidence in biosimilars, develop a strong national biosimilars policy and address regional variability, improve public procurement and adapt clinical practice guidelines following the commercialization of biosimilars. By implementing a holistic and evidence-based policy, Spain can fully exploit the benefits of biosimilar medicines and ensure better and equitable access across the healthcare system.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141261726","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

Small molecule-regulated switches to provide functional control of CAR T cells within the patient. 通过小分子调控开关，对患者体内的 CAR T 细胞进行功能控制。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-06-01 Epub Date: 2024-06-29 DOI: 10.1080/14712598.2024.2371034

Charlotte U Zajc, Elise Sylvander, Manfred Lehner, Michael W Traxlmayr

引用次数: 0

Monoclonal antibodies for moderate-to-severe atopic dermatitis: a look at phase III and beyond. 治疗中重度特应性皮炎的单克隆抗体：III 期及以后的展望。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-06-01 Epub Date: 2024-06-19 DOI: 10.1080/14712598.2024.2368192

Eden David, Kelly Hawkins, Neda Shokrian, Ester Del Duca, Emma Guttman-Yassky

引用次数: 0

Antibody-based therapeutics for chronic rhinosinusitis with nasal polyps. 治疗慢性鼻炎伴鼻息肉的抗体疗法。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-06-01 Epub Date: 2024-06-20 DOI: 10.1080/14712598.2024.2370397

Shama Shishodia, Nora Haloob, Claire Hopkins

{"title":"Antibody-based therapeutics for chronic rhinosinusitis with nasal polyps.","authors":"Shama Shishodia, Nora Haloob, Claire Hopkins","doi":"10.1080/14712598.2024.2370397","DOIUrl":"10.1080/14712598.2024.2370397","url":null,"abstract":"Introduction: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a prevalent inflammatory condition with heterogenous underlying endotypes, the most common being type 2 mediated inflammation. Several biologics have been developed to target specific pro-inflammatory cytokines and their receptors with proven efficacy in both quantitative and qualitative outcomes in patients with severe uncontrolled disease. However, there is an ongoing debate on the role of biologics relative to conventional therapies for CRSwNP and their efficacy in patient subgroups with non-polyp type 2 disease.Areas covered: This review examines the evidence on the efficacy and safety of biologics in CRSwNP, recommendations for their use, and discusses the broader economic factors influencing their application in clinical practice.Expert opinion: Emerging real-life data demonstrating the variable efficacy of the available biologics for patients with CRSwNP, coupled with the high cost compared to conventional therapies such as surgery, renders biologics to be considered as an add-on therapy in the majority of cases. However, ongoing research into increasing biologic dose intervals and novel therapies targeting alternative pathways may offer a more cost-effective and sustainable option in future.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141426617","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

Comparative analysis of GMO regulatory requirements for AAV vectors in the EU and Japan focusing on the shedding data and containment measures. 欧盟和日本对 AAV 向量的 GMO 监管要求的比较分析，重点是脱落数据和遏制措施。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-06-01 Epub Date: 2024-06-28 DOI: 10.1080/14712598.2024.2371042

Hirokuni Mizoguchi, Tobias Fleischmann, Masato Komuro, Takahiro Hirai, Akiko Ikeda, Kojiro Saito, Tomohiro Watahiki, Gentaro Tajima

{"title":"Comparative analysis of GMO regulatory requirements for AAV vectors in the EU and Japan focusing on the shedding data and containment measures.","authors":"Hirokuni Mizoguchi, Tobias Fleischmann, Masato Komuro, Takahiro Hirai, Akiko Ikeda, Kojiro Saito, Tomohiro Watahiki, Gentaro Tajima","doi":"10.1080/14712598.2024.2371042","DOIUrl":"10.1080/14712598.2024.2371042","url":null,"abstract":"Introduction: Recombinant viral-based gene therapy products, such as those incorporating adeno-associated viruses (AAVs), fall under the category of genetically modified organisms (GMOs). The European Union (EU) countries and Japan must obtain environmental risk assessment (ERA) approval for the use of GMOs before starting any clinical trials. It has been reported that the development of GMO-containing products in these two regions encounters several regulatory obstacles due to the longer regulatory procedures and document preparation for ERA.Areas covered: In this article, we comparatively analyzed the ERA document requirements in the EU and Japan for AAV-based recombinant medicinal products to highlight the differences in the context of potential future attempts of convergence. Additionally, we analyzed non-clinical and clinical shedding data requirements, which are key components of ERA reviews in the EU and Japan. Lastly, we compared the containment measures to minimize the spread of GMOs in the environment in the EU and Japan.Expert opinion: Based on our comparative analysis, we present several policy recommendations of standardizing and simplifying the application materials and procedures for the ERA regulations on GMOs in the EU and Japan in the mid-, and long-term timeframe to achieve global regulatory convergence.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141450211","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