On January 7, Andrew Spiegel, executive director of the Global Colon Cancer Association and ASBM Steering Committee member, presented before the U.S. Food and Drug Administration (FDA) providing a patient perspective on why safety must be the ultimate priority when approving biosimilars.
During his oral presentation before at the FDA’s Oncologic Drugs Advisory Committee (ODAC) public meeting he said the following:
“Fundamentally, patients want to know that we can expect the same safety, purity, quality and efficacy from an FDA-approved biosimilar that we can from its FDA-approved reference biologic. That level of confidence can only come through data which demonstrates therapeutic equivalence over time. That means observing the effects of these medicines in larger populations, through clinical trials and post-market surveillance.
“Another key to effective pharmacovigilance would be for the FDA to require any approved biosimilar to have a nonproprietary name distinguishable both from its reference biologic, as well as from other approved biosimilars. This will allow for physicians, pharmacists to know exactly which medicine their patient is receiving, ensure accurate attribution and tracking of adverse events, hold manufacturers accountable for the safety of their products, and help all of us better understand how these medicines work. ”
View his full testimony here.