As 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 American Society of Clinical Oncology (ASCO) is committed to providing education and guidance to the oncology community on the use of biosimilars in the cancer setting. Therefore, ASCO has developed this statement to offer 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 learn more please visit ASCO’s Statement on Biosimilars.
In addition, the FDA noted the following in regards to biosimilars:
• A biosimilar is a biological product
• A biosimilar is highly similar to a reference product
• A biosimilar has no clinically meaningful differences from a reference product
• A biosimilar is approved by the FDA after rigorous evaluation and testing by the applicant
The FDA’s hope is that an efficient path for demonstrating product interchangeability with brands will help build prescriber and patient confidence in switching to biosimilars. To learn more please visit the FDA’s What is a Biosimilar?