ASCO Issues Statement on Use of Biosimilars in Oncology - Big Molecule Watch

The American Society of Clinical Oncology (ASCO) recently issued a statement on use of biosimilars in oncology.  According to ASCO, “[a]s many biosimilars come to market in the next several years, their use in oncology will play an important role in the future care of patients with cancer.”  The statement offers “guidance in the following areas: (1) naming, labeling, and other regulatory considerations, (2) safety and efficacy of biosimilars, (3) interchangeability, switching, and substitution, (4) value of biosimilars, and (5) prescriber and patient education.”  To date, three biosimilar products have been approved by the FDA in the United States for use in oncology: Sandoz’s Zarxio (filgrastim),  Amgen’s Mvasi (bevacizumab-awwb), and Mylan’s Ogivri (trastuzumab-dkst).  A copy of ASCO’s statement is available here.


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