BIO Comments on Facilitating Competition and Innovation in the Biological Products Marketplace
BIO submitted comments for the Food and Drug Administration (FDA) public hearing on Facilitating Competition and Innovation in the Biological Products Marketplace, which took place on September 4, 2018. BIO remarked on the need to foster a robust, competitive marketplace for biological products to improve patient access to safe, effective, and affordable therapies. BIO unequivocally believes that safe and effective biosimilars and interchangeable products are good for patients and good for public health.
BIO's detailed comments cover topics as they relate to the biosimilars market including interchangeability, analysis of analytical similarity, patented and unpatented uses, regulatory exclusivity, and the Purple Book.