台灣大學藥學專業學院

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11/17/2023	An article entitled “Investigation of Immunogenicity Assessment of Biosimilar Monoclonal Antibodies in the United States” by Ching-An Cheng, Ai-Lei Jiang, Yu-Ru Liu and Lin-Chau Chang, is published in the journal, Clinical Pharmacology & Therapeutics, on 27 August 2023. This article investigated the comparative assessment of immunogenicity profiles between biosimilars and their respective reference biologics in the review reports of the biosimilar monoclonal antibody applications approved by the Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA) as of March 13, 2022. The study found that the maximum differences in anti-drug antibody (ADA) and neutralizing antibody (NAb) incidences between biosimilars and reference products mostly fell within ±15% (-13.6%~12%) and ±20% (-17.4%~17.1%, except extreme values of -23.4% and 66.7%), respectively. In comparison with antineoplastic agents, more immunosuppressants had ADA- (11/11, 100.0% versus 8/10, 80.0%)/NAb- (11/11, 100.0% versus 3/10, 30.0%) positive subjects, and the distribution of the aforementioned incidence differences was wider. The investigated biosimilars with available data for analysis demonstrated a high degree of consistency with the reference products in terms of the impact on pharmacokinetic parameters. No increase in immunogenicity was found in available switching studies. Most (16/22, 72.7%) biosimilars were issued post-marketing requirements that were not directly related to immunogenicity concerns. The USFDA considered the totality of evidence assessing clinical consequences of immunogenicity differences, if any. Additional information on titers and subgroup analysis may be warranted to elucidate the critical attributes of immunogenicity impact and to aid in forming cost-effective strategies for biosimilar development. Please click here for the original article. 感謝「臺大藥學發展永續基金計畫」對於國際藥政法規科學研究平台之支持，鄭慶安、姜愛蕾、劉育汝、張琳巧，以“Investigation of Immunogenicity Assessment of Biosimilar Monoclonal Antibodies in the United States”為題之文章，已於2023年8月27日發表於Clinical Pharmacology & Therapeutics期刊。此研究調查截至2022年3月13日為止，美國食品藥物管理局 (FDA) 藥物評估與研究中心 (CDER) 批准的單株抗體生物相似藥 (biosimilar) 申請案審核報告中，生物相似藥與其對照生物製劑的免疫原性特徵之比較評估。研究結果顯示，生物相似藥與對照生物製劑之間的抗藥抗體 (ADA) 和中和抗體 (NAb) 發生率的最大差異，大部分落在±15% (-13.6%〜12%) 和±20% (-17.4%〜17.1%，除了-23.4%和66.7%的極端值) 之間。與抗腫瘤藥物相比，更多的免疫抑制劑具有ADA陽性 (11/11，100.0%對比8/10，80.0%)/NAb陽性 (11/11，100.0%對比3/10，30.0%) 受試者，且發生率差異的分布範圍更廣。含可供分析數據之的生物相似藥申請案，在藥物動力學參數影響方面與其對照生物製劑具高度一致性。於現有的換藥研究中，並未發現免疫原性的增加。大多數 (16/22，72.7%) 生物相似藥申請案之上市後要求與免疫原性議題不直接相關。假使免疫原性結果顯示其可能具差異性，美國FDA以證據整體是否呈現對於臨床反應具顯著影響進行評估。若能額外進行抗體效價和次群體分析，將可能有助於闡明免疫原性影響的關鍵屬性，並有助於制定具成本效益之開發生物相似藥的策略。請參考原始文獻。
03/27/2023	The debate on the acts related to regenerative medicine. A statement of objection addressed by The Pharmaceutical Society of Taiwan, Taiwan Society of Regulatory Affairs for Medical Products, and Platform for Research and Inspiration in Regulatory Science, School of Pharmacy, College of Medicine, National Taiwan University. Original Chinese version
03/27/2023	Comments on the solution of the drug shortage crisis on udn.com by Prof. Li-Jiuan Shen, Dean of School of Pharmacy, College of Medicine, National Taiwan University. Original Chinese version
03/27/2023	Comments on regulating regenerative medicine on Liberty Times Net by Prof. Li-Jiuan Shen, Dean of School of Pharmacy, College of Medicine, National Taiwan University. Original Chinese version
03/27/2023	An article entitled “Regulatory considerations for generic products of non-biological complex drugs” by Yu-Hsuan Liu, Yi-Shuo Chen, Ting Tseng, Min-Lin Jiang, Churn-Shiouh Gau, and Lin-Chau Chang, is published in the journal, Journal of Food and Drug Analysis, on 15 March 2023. This article compares EU and US requirements for developing generic non-biological complex drugs (NBCDs), such as nab-paclitaxel injections and liposomal injections. Pharmaceutical comparability through comprehensive characterization is essential, but approval pathways and requirements may differ. Harmonization of regulations is expected through the pilot program established by the European Medicines Agency (EMA) and Food and Drug Administration (FDA), facilitating NBCD follow-on versions. Authors are grateful for the support from the National Taiwan University School of Pharmacy Endowment Fund in support of the Platform for Research and Inspiration in Regulatory Science. Please click here for the original article. 感謝「臺大藥學發展永續基金計畫」對於國際藥政法規科學研究平台之支持，劉于萱、陳怡碩、曾婷、江旻霖、高純琇、張琳巧，以“Regulatory considerations for generic products of non-biological complex drugs”為題之文章，已於2023年3月15日發表於Journal of Food and Drug Analysis期刊。此研究比較歐盟和美國在非生物複雜藥物 (NBCD) 於審查要求上的差異，其中包括奈米載體紫杉醇注射劑和微脂粒注射劑等藥物。研究指出，透過詳細結構及特徵鑑定來證明藥劑相似性是非常重要的，然而在審查途徑和法規要求面上可能仍存有差異。歐洲醫藥管理局 (European Medicines Agency, EMA) 和美國食品藥品管理局 (Food and Drug Administration, FDA) 共同合作的先導計畫 (pilot program)，有望實現法規審查要求的一致性，進而促進NBCD的學名藥開發。請參考原始文獻。
04/06/2022	The debate on regulating regenerative medicine. A statement of objection addressed by The Pharmaceutical Society of Taiwan, Taiwan Society of Health-System Pharmacists, Taiwan Society of Regulatory Affairs for Medical Products, and National Taiwan University School of Pharmacy - Platform for Research and Inspiration in Regulatory Science Original Chinese version For further information
03/22/2022	An article entitled “Orphan drug development: The impact of regulatory and reimbursement frameworks” by Yu-Jun Huang, Wan-Yu Chao, Chi-Chuan Wang, Lin-Chau Chang is published in the journal, Drug Discovery Today, on 4 March 2022. The article discusses the regulatory and reimbursement frameworks in regions that enacted orphan drug-specific legislation, including the USA, the European Union, Australia, Japan, and Taiwan. The comparison of the frameworks, their impact on the numbers of orphan drug designations and approvals, and the challenges currently encountered could serve as valuable references for countries with comparable healthcare systems to take further measures regarding the implementation of orphan drug legislation. Authors are grateful for the support from the National Taiwan University School of Pharmacy Endowment Fund in support of the Platform for Research and Inspiration in Regulatory Science. Please click here for the original article. 感謝「臺大藥學發展永續基金計畫」對於國際藥政法規科學研究平台之支持，黃郁鈞、趙婉妤、王繼娟、張琳巧，以“Orphan drug development: The impact of regulatory and reimbursement frameworks”為題之文章，已於2022年3月4日發表於Drug Discovery Today期刊。此研究討論已制定罕見疾病藥品相關法案之地區，其法規與保險給付之架構，包含美國、歐盟、澳洲、日本與臺灣法規與保險給付架構比較之結果、其對罕見疾病藥品認定與其中獲得上市許可藥品數量的影響、及當前所面臨之挑戰，可作為其他具相似體制國家於建制罕見疾病用藥相關法規上之重要參考。請參考原始文獻。
03/14/2022	Authors are grateful for the support from the National Taiwan University (NTU) School of Pharmacy Endowment Fund in support of the Platform for Research and Inspiration in Regulatory Science. An article entitled “The impact of The Rare Disease and Orphan Drug Act in Taiwan” by Ning-Chun Hsiang, Weng-Foung Huang, Churn-Shiouh Gau, Teng-Wen Tsai, Lin-Chau Chang is published in the journal, Journal of Food and Drug Analysis, on 15 December 2021. The Rare Disease and Orphan Drug Act (the Act) was enacted in 2000 in Taiwan. In order to investigate the impact of the Act on the availability and use of orphan drugs in Taiwan, this study analyzed the official annual reports and documents. The Act increased the availability of orphan drugs in Taiwan. However, the soaring economic burden was noticed and was anticipated to aggravate. More communication and cooperation between stakeholders is critical in finding solutions for the long-term sustainability of the National Health Insurance system. Authors are grateful for the support from the National Taiwan University (NTU) School of Pharmacy Endowment Fund in support of the Platform for Research and Inspiration in Regulatory Science. Please click here for the original article. 感謝「臺大藥學發展永續基金計畫」對於國際藥政法規科學研究平台之支持，項甯珺、黃文鴻、高純琇、蔡騰文、張琳巧，以“The impact of The Rare Disease and Orphan Drug Act in Taiwan”為題之文章，已於2021年12月15日發表於Journal of Food and Drug Analysis期刊。臺灣於2000年公布施行「罕見疾病防治及藥物法」，為了解此法案對臺灣罕見疾病用藥之可取得性及使用情形的影響，本研究分析官方藥物年報及文件。此法案確實增加罕見疾病用藥之可取得性，但急遽增長之財政負擔有待利益相關人更多之溝通與合作，為全民健康保險體系尋得永續經營的解決之道。請參考原始文獻。
09/02/2021	An article entitled “Investigation of factors associated with immunogenicity labeling updates and characteristics of Biologics License Applications” by Ai-Lei Jiang, Christopher D. Breder and Lin-Chau Chang is recently published in the journal, Clinical Pharmacology & Therapeutics. Through the study of immunogenicity information in the labeling of Biologics License Applications (BLAs) approved by the Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, it was found that critical information was frequently insufficient in original labeling documents. An overdependence on postmarketing requirements for more evidence was noticed. The findings suggested that more investigation for the clinical significance of antidrug antibodies should be performed before approval to provide timely information for improved patient care. Authors are grateful for the support from the National Taiwan University (NTU) School of Pharmacy Endowment Fund in support of the Platform for Research and Inspiration in Regulatory Science. Please click here for the original article. 感謝「臺大藥學發展永續基金計畫」對於國際藥政法規科學研究平台之支持，姜愛蕾、Christopher D. Breder、張琳巧，以“Investigation of factors associated with immunogenicity labeling updates and characteristics of Biologics License Applications”為題之文章，最近發表於Clinical Pharmacology & Therapeutics期刊。經由研究美國食品藥物管理局、藥品評估與研究中心所審核通過之生物製劑申請案，其仿單中關於免疫原性的敘述而得知，原始仿單中對於免疫原性之重要資訊大多並不完整，過於仰賴要求於上市後進行之後續研究以獲取更多證據。建議應在上市前對於抗藥物抗體在臨床上之重要性有更充分的探討，以利及時提供足夠的資訊，有助於患者之用藥安全。請參考原始文獻。
06/16/2021	Fast-tracking vaccine batch releases by Adjunct Prof. Weng-Foung Huang, Adjunct Professor, Institute of Health & Welfare Policy, National Yang Ming Chiao Tung University, translated by Perry Svensson, Taipei Times Original Chinese version
02/28/2021	Program to administer vaccines key component by Prof. Li-Jiuan Shen, Professor/Dean, School of Pharmacy, College of Medicine, National Taiwan University, translated by Paul Cooper, Taipei Times Original Chinese version