WHO Meeting Looks Forward on Distinguishable Names

By Brian Kennedy, Executive Director, Global Alliance for Patient Access This month’s World Health Organization Open Sessions with INN Stakeholders explored the value, and the future, of the biological qualifier system. The Global Alliance for Patient Access was pleased to present to WHO officials and an international group of fellow stakeholders. While there, I conveyed […]

World Health Organization Finalizes Distinct Naming Scheme for Biological Medicines

After years of international debate, the World Health Organization has issued its final proposal embracing distinct names for biological medicines, including biosimilars. The organization opts for four-letter biological qualifiers to follow biological medicines’ international nonproprietary name.   The approach acknowledges patient and advocates’ concerns that distinct names be applied to ensure clarity, patient safety and the […]

Airline Analogy Enlivens Biosimilar Naming Discussions

How can regulators effectively create distinguishable names for biosimilars? For years, the World Health Organization, U.S. Food and Drug Administration and other drug regulatory authorities have wrestled with this vexing question. Now, a solution may have an unlikely inspiration: the airline industry. At the WHO’s June Front Page Meeting, stakeholders considered the INN Expert Committee’s […]

WHO Faces Challenge to Develop Simple Solution to Complex Issue of Naming

by Brian Kennedy, Executive Director On behalf of the Global Alliance for Patient Access I participated in this week’s International Nonproprietary Names (INN) Biological Qualifier (BQ) Comments Review: Front Page Meeting with Stakeholders, held at the World Health Organization Headquarters in Geneva, Switzerland. The WHO’s INN Expert Group faces a significant challenge, as reflected in this week’s meeting and […]

WHO Calls for Improved, Science-based Regulations on Biosimilars

Patients worldwide need access to affordable biosimilars, the World Health Organizations’ World Health Assembly (WHA) says, but not at the expense of safety or science. In a resolution passed at the assembly’s 67th meeting in Geneva, the organization urges member nations to adjust national regulations to accommodate the growing demand for biosimilars – while simultaneously […]