Motola Domenico, De Ponti Fabrizio, Poluzzi Elisabetta, Martini Nello, Rossi Pasqualino, Silvani Maria Chiara, Vaccheri Alberto, Montanaro Nicola
Department of Pharmacology and Interuniversity Research Centre for Pharmacoepidemiology, University of Bologna, Bologna, Italy.
Br J Clin Pharmacol. 2006 Nov;62(5):610-6. doi: 10.1111/j.1365-2125.2006.02700.x. Epub 2006 Jun 23.
In a previous paper, we proposed an algorithm to assess the degree of therapeutic innovation of the agents approved by the European centralized procedure, which must be followed by biotechnological products and is optional for drugs claimed as innovative. A low overall degree of therapeutic innovation (about 30%) was found. This figure may be an underestimate of the actual level of innovation, because common biotechnological products, such as recombinant human insulins, must follow this procedure. To test the hypothesis that therapeutic innovation prevails among nonbiotechnological products, we evaluated separately the degree of therapeutic innovation of biotechnological vs. nonbiotechnological agents in the first decade of European Medicines Agency activity, also studying a possible time trend.
We assessed, for each drug: (i) the seriousness of the target disease, (ii) the availability of previous treatments, and (iii) the extent of therapeutic effect according to the previously proposed algorithm.
Our analysis considered 251 medicinal products corresponding to 198 active substances, classified according to four main areas as therapeutic agents (88.9%), diagnostics (5.5%), vaccines (5.1%) and life-style drugs (0.5%). Among all therapeutic agents, 49 out of 176 agents (28%) were classified as having an important degree of therapeutic innovation. Fifteen out of 60 biotechnological therapeutic agents were considered important therapeutic innovations (25%), whereas this figure was 29% for nonbiotechnological agents.
Among active substances claimed as innovative by the manufacturers, only a minority deserve this definition according to our algorithm.
在之前的一篇论文中，我们提出了一种算法，用于评估通过欧洲集中程序获批的药物的治疗创新程度，生物技术产品必须遵循该程序，而声称具有创新性的药物则可选择遵循。结果发现治疗创新的总体程度较低（约30%）。这个数字可能低估了实际的创新水平，因为常见的生物技术产品，如重组人胰岛素，必须遵循此程序。为了检验非生物技术产品中治疗创新占主导的假设，我们分别评估了欧洲药品管理局成立头十年中生物技术药物与非生物技术药物的治疗创新程度，同时研究了可能的时间趋势。
我们针对每种药物评估：（i）目标疾病的严重程度，（ii）既往治疗方法的可获得性，以及（iii）根据先前提出的算法评估治疗效果的程度。
我们的分析涉及对应198种活性物质的251种药品，根据四个主要领域分类为治疗药物（88.9%）、诊断药物（5.5%）、疫苗（5.1%）和生活方式药物（0.5%）。在所有治疗药物中，176种药物中有49种（28%）被归类为具有重要程度的治疗创新。60种生物技术治疗药物中有15种被认为是重要的治疗创新（25%），而非生物技术药物的这一比例为29%。
在制造商声称具有创新性的活性物质中，根据我们的算法，只有少数名副其实。
