Oncology Biosimilars Bring Hope to Patients with Cancer
Biosimilars for rituximab, trastuzumab, and bevacizumab are currently approved for use in the European Union.
ABP-215 (bevacizumab-awwb; Mvasi), a biosimilar for bevacizumab (Avastin), was approved by the FDA In September 2017 for the treatment of adult patients with colorectal, lung, brain, kidney, and cervical cancers. This was the first approval of a biosimilar in the United States for the treatment of patients with cancer.
ABP-215 was followed by the approval of MYL-1401O (Ogivri; trastuzumab-dkst), a biosimilar for trastuzumab (Herceptin), in December 2017.
MYL-1401O is approved for the treatment of HER2-positive patients with breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma. It is currently approved for the same indications as trastuzumab; however, Genentech, the manufacturer of trastuzumab, holds an exclusive license for the metastatic gastric cancer indication. Therefore, the companies cannot market MYL-1401O for that purpose until the exclusive license expires.
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