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Multi-Centre, Observational Study on Safety of Bevacizumab Biosimilars in Clinical Practice Among Chinese Patients

NCT05009017 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 272

Last updated 2021-08-17

No results posted yet for this study

Summary

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.

Conditions

  • Biosimilar

Interventions

DRUG

Bevacizumab

Patients with colorectal cancer or lung cancer who use originator or biosimilar of bevacizumab

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-07-31
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05009017 on ClinicalTrials.gov