Medicines Regulation in the Middle East and the Importance of the World Health Organization’s Biological Qualifier Program

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When it comes to monitoring the quality, safety and efficacy of biological medicines, distinguishable naming is imperative because biosimilar therapies are similar to, but not exactly the same as, existing biologic medicines. Since no biosimilar is perfectly identical to its innovator parent, every biosimilar must be fully distinguishable to permit quick and accurate tracing of its manufacturer, should an adverse event be observed. Precise naming will improve patient safety by reducing confusion and mishaps in prescribing — holding manufacturers accountable. Also, differential nomenclature helps enable national health authorities to collect and compare real-world data that measure the clinical effects of biologics including biosimilars. Insights from such data, over time, will enable us to better measure a drug’s effectiveness in delivering successful health outcomes for patients.

The WHO must finalize their BQ guidance. It is this organization that has the responsibility to ensure that developing nations of the world have access to affordable, quality medicines. Safety is mission critical and the Biosimilar Qualifier is a potent tool on behalf of global public health.

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