Expert Opinion on Biological Therapy最新文献_第7页

The role of bDMARDs in the prevention and treatment of inflammatory-related comorbidities in Psoriatic Arthritis bDMARDs 在预防和治疗银屑病关节炎炎症相关并发症中的作用

IF 4.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-22 DOI: 10.1080/14712598.2024.2384090

Francesco Caso, Mauro Fatica, Mario Ferraioli, Matteo Megna, Luca Potestio, Angelo Ruggiero, Nello Tommasino, Francesco Maione, Raffaele Scarpa, Maria Sole Chimenti, Luisa Costa

引用次数: 0

Short and long-term economic implications of biosimilars. 生物仿制药的短期和长期经济影响。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-01-19 DOI: 10.1080/14712598.2024.2307353

Ahmad Z Al Meslamani

{"title":"Short and long-term economic implications of biosimilars.","authors":"Ahmad Z Al Meslamani","doi":"10.1080/14712598.2024.2307353","DOIUrl":"10.1080/14712598.2024.2307353","url":null,"abstract":"Introduction: Biosimilars are gaining popularity due to their ability to offer comparable therapeutic benefits at potentially lower costs.Areas covered: This article analyses studies that compare the cost savings of biosimilars with biologics. It also explores market competition dynamics and the impact of policies in countries. The focus is on the advantages of biosimilars in oncology and rheumatological treatments while considering broader economic implications for the pharmaceutical industry such as market displacement, pricing strategies and their influence on innovation and healthcare sustainability.Expert opinion: The introduction of biosimilars marks a shift in healthcare economics by offering cost reductions and long-term potential for economic balance. However, I also recognize challenges related to research methodologies and regulatory inconsistencies across countries. To fully capitalize on their potential, future research and development in the field of biosimilars must emphasize harmonized approaches and comprehensive studies that ensure both cost containment in healthcare and wider access, to high quality treatments.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"567-570"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139477560","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

Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan. 修订日本生物仿制药开发对日本临床研究数据的要求。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-07-09 DOI: 10.1080/14712598.2024.2377300

Ryosuke Kuribayashi, Kanoko Goto, Aya Hariu, Yasuhiro Kishioka

{"title":"Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan.","authors":"Ryosuke Kuribayashi, Kanoko Goto, Aya Hariu, Yasuhiro Kishioka","doi":"10.1080/14712598.2024.2377300","DOIUrl":"10.1080/14712598.2024.2377300","url":null,"abstract":"Background: The 'Questions and Answers (Q&A)' document regarding Japanese biosimilar guideline elucidated that Japanese participant enrollment in at least one comparative clinical study was required for the marketing authorization application (MAA) of biosimilars in Japan.Research design and methods: To discuss the requirement of Japanese clinical study data for biosimilar development, the trend in comparative clinical studies conducted for approved biosimilars of monoclonal antibodies and fusion proteins was analyzed, and the consistency of the results between the overall population and the Japanese population according to the publicly available information was reviewed.Results: The number of comparative clinical studies enrolling Japanese participants was 25 cases, and the type and percentage were 13 (52%) and 12 (48%) cases of comparative pharmacokinetic study and comparative efficacy study, respectively. In all comparative clinical studies, consistent results between the overall population and the Japanese population were shown.Conclusions: Our study indicated that Japanese participant enrollment in comparative clinical studies may not always be necessary for biosimilar development when certain conditions are satisfied. This has been described in the revised Q&A document published by the Ministry of Health, Labour and Welfare in January 2024.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"637-645"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141544666","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

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-05-14 DOI: 10.1080/14712598.2024.2350440

Rocío Vázquez-Sánchez, Marco Navarro-Dávila, Esther Ramírez Herráiz, Vicente Merino-Bohórquez, Joaquín Borrás-Blasco, Alberto Onteniente-González, Ana Iglesias-Lambarri, Eva Negro-Vega

{"title":"Biosimilars and access to biologic therapy in immune-mediated diseases.","authors":"Rocío Vázquez-Sánchez, Marco Navarro-Dávila, Esther Ramírez Herráiz, Vicente Merino-Bohórquez, Joaquín Borrás-Blasco, Alberto Onteniente-González, Ana Iglesias-Lambarri, Eva Negro-Vega","doi":"10.1080/14712598.2024.2350440","DOIUrl":"10.1080/14712598.2024.2350440","url":null,"abstract":"Background: The rise of biologic agents has been a major breakthrough in treating immune-mediated inflammatory diseases (IMIDs). However, their high cost underscores the need for strategies to optimize treatment efficiency. Biosimilars offer cost-effective alternatives to biologics. This study aimed to assess biosimilar drug availability's impact on biologic therapy access for IMIDs.Research design and methods: A retrospective observational study in 15 Spanish hospitals analyzed IMID patients (arthropathies, inflammatory bowel disease and psoriasis) initiating biologic therapy with originator or biosimilar drugs (infliximab, etanercept, adalimumab). Time to availability and initiation of biologic therapy were assessed.Results: 267 patients were included, with 58.4% starting on biosimilars. The mean time to availability of the biologic drugs in the hospitals was 15.9 ± 6.7 months, (20.0 ± 12.4 for originator and 11.8 ± 5.2 for biosimilars). Mean time to biologic treatment was 7.7 ± 9.0 years (8.6 ± 8.9 for originators and 7.0 ± 9.0 for biosimilars). Showing statistically significant differences among conditions.Conclusion: The emergence of biosimilar drugs has enhanced market competition and accelerated their adoption into hospitals' therapeutic regimens over original reference drugs. This has significantly improved access to biologic therapy for patients with IMIDs, evidenced by a notable 1.6-year reduction in access time for biosimilar drugs.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"647-653"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140852659","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

Streamlining biosimilar development based on 20 years' experience. 基于 20 年的经验，简化生物仿制药的开发。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-02-22 DOI: 10.1080/14712598.2024.2314612

Cecil Nick

{"title":"Streamlining biosimilar development based on 20 years' experience.","authors":"Cecil Nick","doi":"10.1080/14712598.2024.2314612","DOIUrl":"10.1080/14712598.2024.2314612","url":null,"abstract":"Introduction: Biosimilar clinical programs could be streamlined by prudent application of improved methodologies and knowledge accumulated over the past 20 years. This review focuses on whether complex comparative efficacy trials are routinely needed and how to achieve a more tailored approach to biosimilar development.Areas covered: Key learnings over the past 20 years are summarized. It is noted that a one size fits all approach to biosimilar development is not appropriate: biological medicines fall within a wide spectrum of complexity, with blurring at the interface between biological products and small molecules. The interrelationship between quality, potency, pharmacokinetics, pharmacology, immunogenicity, efficacy, and safety are reviewed. Current regulatory thinking is reviewed with a look into what future challenges lie ahead.Expert opinion: To tailor regulatory requirements for marketing approval of biosimilars, it is proposed that a biosimilarity report be introduced. This report would integrate quality, pharmacology, immunogenicity, efficacy and safety findings and address how the clinical program could be tailored based on the totality of evidence.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"571-581"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691583","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

Non-TNF biologics and their biosimilars in rheumatoid arthritis. 治疗类风湿性关节炎的非 TNF 生物制剂及其生物仿制药。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-05-22 DOI: 10.1080/14712598.2024.2358165

Tsz Ching Mok, Chi Chiu Mok

{"title":"Non-TNF biologics and their biosimilars in rheumatoid arthritis.","authors":"Tsz Ching Mok, Chi Chiu Mok","doi":"10.1080/14712598.2024.2358165","DOIUrl":"10.1080/14712598.2024.2358165","url":null,"abstract":"Introduction: Rheumatoid arthritis (RA) is a chronic inflammatory rheumatic disease that affects both the articular and extra-articular structures, leading to significant joint damage, disability and excess mortality. The treatment algorithm of RA has changed tremendously in the past 1-2 decades because of the emergence of novel biological therapies that target different mechanisms of action in addition to TNFα.Areas covered: This article summarizes the evidence and safety of the non-TNF biological DMARDs in the treatment of RA, including those that target B cells, T-cell co-stimulation, interleukin (IL)-6 and granulocyte-monocyte colony-stimulating factor (GM-CSF). The targeted synthetic DMARDs such as the Janus kinase inhibitors are not included. The availability of the less costly biosimilars has enabled more patients to receive biological therapy earlier in the course of the disease. The evidence for the non-TNF biosimilar compounds in RA is also reviewed.Expert opinion: There are unmet needs of developing novel therapeutic agents to enhance the response rate and provide more options for difficult-to-treat RA. These include the newer generation biologic and targeted synthetic DMARDs. A personalized treatment strategy in RA requires evaluation of the cellular, cytokine, genomic and transcriptomic profile that would predict treatment response to biologic or targeted DMARDs of different mechanisms of action.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"599-613"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141065309","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

Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study. 通过自动注射器或预灌装注射器给药的候选托珠单抗生物仿制药 CT-P47 的药代动力学和安全性：一项随机、开放标签、单剂量 I 期研究。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-06-21 DOI: 10.1080/14712598.2024.2321360

Kyung-Sang Yu, Hyunwook Ryu, Dongseong Shin, MinKyu Park, JunGi Hwang, Seol Ju Moon, Min-Gul Kim, Edward Keystone, Josef S Smolen, SungHyun Kim, YunJu Bae, DaBee Jeon, JiYoung Jang, GoEun Yang, JiHun Bae, JaeYong Lee, Gerd R Burmester

{"title":"Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study.","authors":"Kyung-Sang Yu, Hyunwook Ryu, Dongseong Shin, MinKyu Park, JunGi Hwang, Seol Ju Moon, Min-Gul Kim, Edward Keystone, Josef S Smolen, SungHyun Kim, YunJu Bae, DaBee Jeon, JiYoung Jang, GoEun Yang, JiHun Bae, JaeYong Lee, Gerd R Burmester","doi":"10.1080/14712598.2024.2321360","DOIUrl":"10.1080/14712598.2024.2321360","url":null,"abstract":"Background: This study compared the pharmacokinetics (PK), immunogenicity, and safety of candidate tocilizumab biosimilar, CT-P47, administered via auto-injector (CT-P47 AI) or pre-filled syringe (CT-P47 PFS), in healthy Asian adults.Research design and methods: In this phase I, multicenter, open-label study, participants were randomized 1:1 to receive a single 162 mg/0.9 mL dose of CT-P47 via AI or PFS. Primary endpoints were area under the concentration - time curve from time zero to infinity (AUC0-inf) and maximum serum concentration (Cmax). PK equivalence was determined if 90% confidence intervals (CIs) for the ratios of geometric least-squares means (gLSMs) were within the predefined 80-125% equivalence margin. Secondary PK parameters, immunogenicity, and safety outcomes were also assessed.Results: Of 314 participants randomized (155 CT-P47 AI; 159 CT-P47 PFS), 310 received the study drug (153 CT-P47 AI; 157 CT-P47 PFS). Primary and secondary PK results, immunogenicity and safety were similar between groups. Ninety percent CIs for the ratio of gLSMs were within the predefined equivalence margin for AUC0-inf (85.87-102.94) and Cmax (82.98-98.16).Conclusions: PK equivalence between CT-P47 AI and CT-P47 PFS was demonstrated in healthy Asian adults, with comparable immunogenicity and safety between the two devices.Trial registration: ClinicalTrials.gov: NCT05617183.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"681-689"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141436756","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

Infliximab biosimilar GP1111: a review of 5 years' post-approval experience. 英夫利西单抗生物仿制药 GP1111：批准后 5 年经验回顾。

IF 3.6 3区医学

Expert Opinion on Biological Therapy Pub Date : 2024-07-01 Epub Date: 2024-07-27 DOI: 10.1080/14712598.2024.2377298

Thomas W J Huizinga, Valeria Dipasquale, Markus Zabransky, Jens Heyn, Claudio Romano

{"title":"Infliximab biosimilar GP1111: a review of 5 years' post-approval experience.","authors":"Thomas W J Huizinga, Valeria Dipasquale, Markus Zabransky, Jens Heyn, Claudio Romano","doi":"10.1080/14712598.2024.2377298","DOIUrl":"10.1080/14712598.2024.2377298","url":null,"abstract":"Introduction: Infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha, and GP1111 (Zessly®, Sandoz) is the most recently approved infliximab biosimilar in Europe. We reviewed the approval process and key evidence for GP1111, focusing primarily on the indications of rheumatoid arthritis (RA) and inflammatory bowel disease (IBD).Areas covered: This narrative review discusses preclinical, clinical, and real-world data for GP1111.Expert opinion: Results from the Phase III REFLECTIONS trial in patients with moderate-to-severe active RA despite methotrexate therapy confirmed the similarity in efficacy and safety between GP1111 and reference infliximab. Switching from reference infliximab to GP1111 in REFLECTIONS had no impact on efficacy or safety. Since the European approval of GP1111 in March 2018, real-world data have also confirmed the efficacy and safety of switching from another infliximab biosimilar to GP1111 in patients with RA and IBD. In addition, budget impact analysis of various sequential targeted treatments in patients with RA found that GP1111 was cost-effective when used early after failure of conventional synthetic disease-modifying antirheumatic drugs. Therefore, 5 years' post-approval experience with GP1111 in RA and IBD, and key clinical and real-world evidence, support the safety and efficacy of continued use of GP1111 in all infliximab-approved indications.","PeriodicalId":12084,"journal":{"name":"Expert Opinion on Biological Therapy","volume":" ","pages":"615-625"},"PeriodicalIF":3.6,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141554486","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

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":" ","pages":"673-679"},"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":" ","pages":"627-635"},"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