Zulfikari Selvira, Sučić Anita Filipović, Meštrović Koraljka, Barbarić Mirjana Perić, Mandarić Vesna, Zorić Nataša, Tomić Siniša
Coll Antropol. 2015 Jun;39(2):363-70.
A generic medicine is an equivalent of an originator pharmaceutical product. It contains the same active substance as, is "essentially similar" to, and is therefore interchangeable with, the originator product. The objective of this study was to determine the share of generic medicines of the total received marketing authorization applications in Croatia, and the specificities in the approval of generic medicines with regard to assessments of their quality documentation. We collected the information from the Agency's medicinal products databases. Absolute numbers are shown for the applications for the authorizations of medicines in total and generics in particular in the period from 2005-2009. Data were analyzed using descriptive statistics. The annual number of marketing authorization applications for generic medicines received in Croatia increased from 148 applications in 2005 to 276 applications in 2009. In the period from 2005-2009, the number of applications for the approval of generic medicines accounted for 55% of all submitted applications. More than five generic medicines were approved for the following active compounds: amlodipine, lisinopril, atorvastatin, tamsulosin and omeprazole. In the following years, the number of applications from international manufacturers stagnated, while the number of applications by local manufacturers is on a steady climb, with the exception of 2008. From 2005-2009, an almost continual increase in the number of applications for the approval of generic medicines is evident. The largest number of generic medicines was approved for generic medicines intended for the treatment of cardiovascular disease (amlodipine, lisinopril, atorvastatin). A continual increase of applications from local manufacturers has been recorded. In the approval of these medicines, it is very important to develop a uniform approach to assessing the quality of each medicine, in order to guarantee a high quality product for the patient.
仿制药等同于原创药品。它含有与原创产品相同的活性成分， “本质上相似”，因此与原创产品可互换。本研究的目的是确定仿制药在克罗地亚获得上市许可申请总数中的占比，以及在仿制药批准方面有关其质量文件评估的特殊性。我们从该机构的药品数据库收集了信息。列出了2005年至2009年期间药品授权申请总数以及仿制药申请的绝对数量。使用描述性统计方法对数据进行了分析。克罗地亚收到的仿制药上市许可申请数量从2005年的148份增加到2009年的276份。在2005年至2009年期间，仿制药批准申请数量占所有提交申请的55%。以下活性化合物有超过五种仿制药获批：氨氯地平、赖诺普利、阿托伐他汀、坦索罗辛和奥美拉唑。在接下来的几年里，国际制造商的申请数量停滞不前，而当地制造商的申请数量稳步攀升，但2008年除外。从2005年到2009年，仿制药批准申请数量几乎持续增加。获批仿制药数量最多的是用于治疗心血管疾病的仿制药（氨氯地平、赖诺普利、阿托伐他汀）。当地制造商的申请数量持续增加。在这些药品的批准过程中，制定统一的药品质量评估方法非常重要，以确保为患者提供高质量的产品。
