1. Biosimilars must be shown to be _____________ with their reference product in order to be granted US Food and Drug Administration approval.

2. JB is a 53-year-old male living in Chicago who presents with suspected chronic lymphocytic leukemia. Following his work-up and awaiting final pathology, his oncologist discusses treatment options, including R-FC (rituximab, fludarabine, cyclophosphamide) chemotherapy. He also notes the possibility of substituting a new biosimilar for rituximab. In reviewing the substitution with JB, which of the following statements about biosimilars should be emphasized?

3. A patient with non-progressing, CD20+, B-cell non-Hodgkin's Lymphoma raises concerns about the out-of-pocket costs associated with the rituximab prescribed in combination with cyclophosphamide, vincristine, and prednisone chemotherapy. She is open to a less expensive alternative. The oncology pharmacist is brought in to counsel the patient about the availability of biosimilar alternatives to rituximab. Which of the following options are available to this patient?

4. Clinical data from separate studies comparing trastuzumab-dkst and trastuzumab and trastuzumab-qyyp and trastuzumab, respectively, in patients with HER2+ breast cancer led investigators to recommend ________________.

5. Tbo-filgrastim is approved to treat patients with severe neutropenia associated with ________________.

6. . ____________is classified as a biosimilar in the European Union but not in the United States.

7. Health professional and patient reluctance to use biosimilars may be attributed to __________.

8. Regulations ground in the notion of the “innovator rebate” and “single-source products” continue to influence the reimbursement policies of biosimilars for __________________.

« Return to Activity