On July 18th, ASBM Advisory Chair Philip Schneider gave a presentation to the Malta Pharmaceutical Association 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. It also focused on the need for Real World Evidence (RWE) and improved pharmacovigilance in a world where biosimilars are approved with an emphasis on analytics rather than clinical trials.
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 these needs. He also offered his observations from ASBM’s April 11th naming forum in Washington, DC, his April 30th meeting with WHO in Geneva, and ASBM’s July 12th Forum in Washington, DC. 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.