Trust, Education Critical to Ensure Patient Access to Biosimilars, FDA Says at Inaugural Biosimilars Council Conference

Today, Janet Woodcock, MD, Director, Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) delivered a keynote address at Leading on Biosimilars: The 2016 GPhA Biosimilars Council Conference.

PRESS RELEASE

WASHINGTON, DC (Sept. 7, 2016) — Today, Janet Woodcock, MD, Director, Food and Drug Administration (FDA) 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.

Statement by Bert Liang, M.D. Ph.D., M.B.A., Chairman, Biosimilars Council and Chief Executive Officer, Pfenex

“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.

The Biosimilars Council applauds Dr .Woodcock’s recognition of these shared priorities as well as the acknowledgement that FDA will need to expand its capacity in order to address this rapidly growing industry. The bottom line is that FDA approved biosimilars are medicines we can trust. Efforts to undermine this trust by misrepresenting sound scientific principles, such as bioequivalence standards, are worrisome and widespread. Misinformation can be countered with improved understanding of proven science — but it will take a collaborative effort between stakeholders from all points of the supply chain.

Confidence in these scientific principles should carry through to policy conversations. Decisions made today are forming the foundation responsible for patient access to these medicines. Building confidence in biosimilar safety and efficacy will help millions of Americans realize the promise of biosimilars —expanded access to more affordable medicine and billions of dollars in patient and health system savings.”