The Safety Study of Bevacizumab Biosimilars in the Real World
试验速览
- 阶段
- 不适用
- 入组人数
- 272
- 试验地点
- 2
- 主要终点
- Adverse drug reactions
研究概览
简要总结
Monoclonal antibody drugs are expensive, and the listing of biosimilar drugs can help increase the availability and lower prices of biologic drugs, and can better meet the public's demand for biotherapeutic products. The first bevacizumab biosimilar in China was launched in December 2019. Although monoclonal antibody biosimilar drugs are similar to the original drug in terms of quality, safety and effectiveness, their production process may be different from the original drug, and their clinical application cannot be completely equivalent to the original drug. Especially after the market is applied to a wider patient population, the safety and effectiveness are more worthy of attention. This study started from the perspective of pharmacy. Three hospitals in China participated in the real-world safety assessment of bevacizumab biosimilars. An observational cohort study design was adopted to include all cases of lung cancer and colorectal cancer using bevacizumab biosimilars and original drugs during the study period, and the propensity score matching was used to reduce the influence of confounding factors and conduct safety assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •①Inpatients diagnosed with non-small cell lung cancer or colorectal cancer; ②Bevacizumab biosimilars or original drugs were used for treatment during the study period.
排除标准
- •①Age<18 years old; ②Person who has used bevacizumab within six months.
研究组 & 干预措施
Biosimilar group
干预措施: Bevacizumab (Drug)
Originator group
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Adverse drug reactions
时间窗: 12 months
Severity of adverse drug reactions
次要结局
未报告次要终点
研究者
Guohui Li
Pharmacy
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
