Search results for Biological Qualifier (BQ)

Medicines regulation in the MENA region and the importance of the World Health Organization’s INN proposal of Biological Qualifier

Author byline as per print journal: Peter J Pitts, BA; Michael S Reilly, Esq Abstract: The World Health Organization should finalize its Biological Qualifier guidance. Distinguishable naming will allow quick and accurate tracing of the manufacturer, should adverse events occur and improve patient safety by reducing confusion and mishaps. This will ensure that developing nations, including […]

Read more →

Clear naming, traceability of biological medicines will protect patients

Author byline as per print journal: Adjunct Professor Valderilio Feijó Azevedo, MD, PhD, MBA; Associate Professor Brian Bressler, MD, MS, FRCPC; Madelaine A Feldman, MD, FACR; Professor Alejandro Mercedes, MD Abstract: As more biological medicines and biosimilars become increasingly available worldwide, clear product identification is critical for accurate pharmacovigilance. Submitted: 25 September 2017; Revised: 25 September […]

Read more →

Prescribing practices for biosimilars: questionnaire survey findings from physicians in Argentina, Brazil, Colombia and Mexico

Author byline as per print journal: Michael S Reilly, Esq; Harry L Gewanter, MD, FAAP, FACR Introduction: World Health Organization (WHO) recommendations for the regulation of biosimilars form the basis of guidelines used across most of Latin America. However, the pace at which the region moves toward reaching its potential of having safe and effective biosimilars […]

Read more →

The challenges of nomenclature – INN, biosimilars and biological qualifiers

Abstract: A novel global and company specific biological qualifier, distinct from the International Nonproprietary Name (INN), is proposed by World Health Organization (WHO) for all biological active substances. Submitted: 14 May 2015; Revised: 2 July 2015; Accepted: 6 July 2015; Published online first: 20 July 2015 Introduction to INN The concept of one single non-proprietary […]

Read more →