Bertoldi Andréa Dâmaso, Wagner Anita K, Emmerick Isabel Cristina Martins, Chaves Luisa Arueira, Stephens Peter, Ross-Degnan Dennis
1Postgraduate Program in Epidemiology, Federal University of Pelotas, Rua Marechal Deodoro, 1160 3º piso, Pelotas, RS CEP 96.020-220 Brazil.
2Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401, Boston, MA 02215 USA.
J Pharm Policy Pract. 2019 Aug 14;12:18. doi: 10.1186/s40545-019-0179-9. eCollection 2019.
To describe changes in the private market for selected originators, branded generics (''), and generic products during the 10 years following passage of the Brazilian Generics Law.
We analyzed longitudinal data collected by IQVIA® on quarterly sales by wholesalers to retail pharmacies in Brazil from 1998 through 2010, grouped by originators, branded generics, and generic products in three therapeutic classes (antibiotics, antidiabetics, and antihypertensives). Outcomes included market share (proportion of the total private market volume), sales volume per capita, prices and number of manufacturers by group.
In the private market share, generics became dominant in each therapeutic class but the speed of uptake varied. Originators consistently lost most market share while branded generics varied over time. By the end of the study period, generics were the most sold product type in all classes, followed by branded generics. The number of generic manufacturers increased in all classes, while branded generics increased just after the policy but then decreased slowly through the end of 2010. For approximately 50% of the antibiotics analyzed, branded generics and generics had lower prices than originators. For antidiabetics, branded generic and generic prices were quite similar during the period analyzed. Price trends for the various subclasses of antihypertensive exhibited very different patterns over time.
Sales of branded generics and originators decreased substantially in the three therapeutic classes analysed following the introduction of the generics policy in Brazil, but the time to market dominance of generics varied by class.
描述巴西《仿制药法》通过后的10年里，特定原研药、品牌仿制药（“ ”）和仿制药产品在私人市场的变化情况。
我们分析了IQVIA®收集的1998年至2010年巴西批发商向零售药店季度销售的纵向数据，按原研药、品牌仿制药和仿制药产品分为三个治疗类别（抗生素、抗糖尿病药和抗高血压药）进行分组。结果包括市场份额（私人市场总量的比例）、人均销售量、价格以及各分组的制造商数量。
在私人市场份额方面，仿制药在每个治疗类别中都占据主导地位，但采用速度各不相同。原研药持续失去大部分市场份额，而品牌仿制药随时间有所变化。到研究期结束时，仿制药是所有类别中销量最大的产品类型，其次是品牌仿制药。所有类别的仿制药制造商数量都有所增加，而品牌仿制药在政策实施后有所增加，但到2010年底缓慢下降。在分析的约50%的抗生素中，品牌仿制药和仿制药的价格低于原研药。对于抗糖尿病药，在所分析的时期内，品牌仿制药和仿制药的价格相当相似。抗高血压药各子类的价格趋势随时间呈现出非常不同的模式。
巴西引入仿制药政策后，在所分析的三个治疗类别中，品牌仿制药和原研药的销售额大幅下降，但仿制药占据市场主导地位的时间因类别而异。
