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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biosimilar group |
| ||
| Originator group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Patients with colorectal cancer or lung cancer who use originator or biosimilar of bevacizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse drug reactions | Severity of adverse drug reactions | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Inpatients in 3 study hospitals diagnosed with non-small cell lung cancer or colorectal cancer using originator or biosimilar of bevacizumab
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guohui Li, Bachelor | Contact | 01087788578 | lgh0603@cicams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Wenzhou Zhang | Not yet recruiting | Zhengzhou | Henan | 450008 | China |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |