On May 24th, ASBM presented at the World Biosimilars Congress USA 2018 in San Diego, CA. The theme of the two-day conference was “Helping the global industry bring biosimilars to the US” and it drew more than 100 attendees including representatives from the industry, health care professionals, and payers.
ASBM Advisory Chair Philip Schneider gave a presentation entitled “Biologic nomenclature: Implementation of an internationally harmonized system”. The presentation offered an overview of the state of international harmonization in the area of biologic naming, including examination of the naming policies of major national regulators and views of health professionals worldwide regarding the need for all biologics, including biosimilars to have distinct non-proprietary names.
Dr. Schneider discussed the feasibility of four-letter suffixes -as proposed by the World Health Organization (WHO) and enacted by the U.S. Food and Drug Administration (FDA)- in addressing this need. He also offered his observations from ASBM’s April 11th naming forum in Washington, DC and his April 30th meeting with WHO in Geneva, emphasizing the importance of the WHO assuming a leadership role on this issue:
“International harmonization is key to building a strong global system of pharmacovigilance, and countries without robust pharmacovigilance systems in place may benefit the most from distinct naming and international harmonization. WHO leadership is essential to achieve this and avoid further proliferation of country-specific naming schemes.”
View Dr. Schneider’s presentation here.