Sowndharya M, Joga Ramesh, Gandhi Kajal, Vijay Gadekar Kailas, Waikar Sonali, Yerram Sravani, Raghuvanshi Rajeev Singh, Srivastava Saurabh
Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research, Hyderabad, Telangana, 500037, India.
Directorate General of Health Services, Ministry of Health & Family Welfare, Central Drug Standard Control Organization (CDSCO), Government of India, New Delhi, India.
Ther Innov Regul Sci. 2025 May 22. doi: 10.1007/s43441-025-00806-x.
This study examines trends in USFDA's authorized generic (AG) approvals from January 2019 to August 2024, focusing on approval patterns, leading therapeutic areas, dominant dosage forms, and key companies. The research aims to highlight market dynamics and the role of AGs in enhancing healthcare accessibility and affordability with case studies.
Data was collected from the FDA's list of authorized generic drugs and analyzed to identify trends in annual approvals, therapeutic areas, and dosage forms. A company-wise analysis was conducted to identify top performers, with a detailed evaluation of their approval trends and strategic focus areas across therapeutic categories. Recent case studies of AGs were included to explore their clinical and economic significance. The impact of the Inflation Reduction Act, Continuing Appropriations Act, of 2020, and Health Extenders Act of 2019 on the definition and pricing of AGs, as well as its implications for the pharmaceutical industry and Medicaid Drug Rebate Program, were examined.
AG approvals peaked in 2019 (31%) and 2020 (33%), then declined. Leading therapeutic areas were cardiovascular (18%), neurology (14%), and endocrinology (13%). Tablets comprised 35% of approvals, followed by capsules (23%) and solutions (9%). GlaxoSmithKline led with 7% of approvals, primarily in pulmonology and migraine, while Bausch Health (6.25%) focused on dermatology and endocrinology. IBSA Pharma (5.47%) excelled in endocrinology and pain management. Pfizer and Cediprof each had 4.69%, with Pfizer focusing on cardiovascular and infectious diseases, and Cediprof specializing in endocrinology. Recent case studies of AGs provided an affordable, effective alternative for diabetes and cardiovascular care.
AGs effectively bridge the transition from branded to generic drugs, supporting broader access to treatment, cost efficiency, and ongoing innovation in the pharmaceutical sector. The analysis highlights AGs' significant role in addressing healthcare needs while underscoring challenges like exclusivity agreements and profit constraints for traditional generics. These findings affirm AGs as pivotal in advancing pharmaceutical market dynamics and healthcare affordability.
本研究考察了2019年1月至2024年8月美国食品药品监督管理局（USFDA）的授权仿制药（AG）批准情况，重点关注批准模式、主要治疗领域、主导剂型和关键公司。该研究旨在通过案例研究突出市场动态以及AG在提高医疗可及性和可负担性方面的作用。
从FDA的授权仿制药清单中收集数据，并进行分析以确定年度批准、治疗领域和剂型方面的趋势。进行了按公司的分析以确定表现最佳的公司，并对其在各治疗类别的批准趋势和战略重点领域进行了详细评估。纳入了AG的近期案例研究以探讨其临床和经济意义。研究了《降低通胀法案》《2020年持续拨款法案》和《2019年医疗延长法案》对AG定义和定价的影响，以及对制药行业和医疗补助药品回扣计划的影响。
AG批准在2019年（31%）和2020年（33%）达到峰值，随后下降。主要治疗领域为心血管（18%）、神经学（14%）和内分泌学（13%）。片剂占批准的35%，其次是胶囊（23%）和溶液剂（9%）。葛兰素史克以7%的批准率领先，主要集中在肺病学和偏头痛领域，而博士伦健康公司（6.25%）专注于皮肤病学和内分泌学。依比沙制药（5.47%）在内分泌学和疼痛管理方面表现出色。辉瑞和赛迪普罗各有4.69%的批准率，辉瑞专注于心血管和传染病领域，赛迪普罗专长于内分泌学。AG的近期案例研究为糖尿病和心血管护理提供了一种经济有效的替代方案。
AG有效地架起了从品牌药到仿制药的过渡桥梁，支持更广泛的治疗可及性、成本效益以及制药行业的持续创新。该分析突出了AG在满足医疗需求方面的重要作用，同时强调了诸如独家协议和传统仿制药的利润限制等挑战。这些发现肯定了AG在推动制药市场动态和医疗可负担性方面发挥的关键作用。
