From June 25-27, ASBM exhibited at the 2018 Drug Industry Association Conference (DIA 2018). ASBM was represented at DIA by Chair Madelaine Feldman MD, FACR and Advisory Board Chair Philip Schneider, MS FASHP.
In addition to meeting attendees at ASBM’s booth, Drs. Feldman and Schneider attended several panels related to biosimilar policy, and engaged participants in discussions of key policy issues. For example:
At a panel on interchangeability, Dr. Feldman asked the FDA’s Leah Christl to clarify whether interchangeability would be transitive. That is, would the FDA would treat two biosimilars- each interchangeable with the same reference product -as interchangeable with each other? Dr. Christl clarified in her answer that no, interchangeability would only be granted to a biosimilar with respect to its reference product and not to another biosimilar, even one deemed interchangeable to that some reference product.
At a panel entitled Global Regulatory Strategies for Biosimilars, Dr. Schneider asked panelists if they supported global harmonization with distinct non-proprietary names and was met with universal support.
Later, Dr. Schneider attended a panel entitled Biosimilar interchangeability: A global perspective. When he asked the panel about the value of distinct naming and international harmonization for improving pharmacovigilance and increasing biosimilar uptake, the panel agreed that real world evidence is critical to uptake and that harmonizing global nonproprietary names is vital in making this happen.
In addition to the ASBM’s presence in the exhibit hall and at biosimilar sessions, an oped by ASBM executive director Michael Reilly was featured in Drug Industry News, a publication distributed to conference attendees. ASBM also used print advertising and tabletop art at the conference to promote its surveys of physicians in 12 countries and of US pharmacists, which show broad support for distinct naming of all biologics, including biosimilars.