Trust and education critical to ensure patient access to biosimilars, says CDER chief

Janet Woodcock, director of the US Food and Drug Administration Center for Drug Evaluation and Research (CDER) delivered a keynote address at Leading on Biosimilars: The 2016 GPhA Biosimilars Council Conference.

In her remarks, Dr Woodcock emphasized the importance of education and the need for patients, providers, pharmacists and others to trust in the science that enables FDA to approve biosimilars as safe, effective alternatives to costly brand biologic drugs.

In response, Bert Liang, chairman of the Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), and chief executive of Pfenex, a biosimilar drug developer, commented: “As Dr Woodcock stated, patients, physicians and pharmacists can be assured that FDA approved biosimilars are just as safe and effective as their brand biologic counterparts. An important point was raised, the success of this burgeoning industry will rely on educating and earning the trust of patients and providers - those closest to the prescription and administration of these medicines.