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.
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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。
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