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

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 biological medicines. Since no biosimilar is perfectly identical to its innovator parent, every biological – whether reference product or biosimilar – must be fully distinguishable from other biologicals to permit quick and accurate tracing of its manufacturer, should an adverse event be observed. Precise naming of all biologicals will improve patient safety by reducing confusion and mishaps in prescribing and holding manufacturers accountable. Also, differential nomenclature helps enable national health authorities to collect and compare real-world data that measure the clinical effects of biologicals 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 World Health Organization (WHO) must finalize their Biologic Qualifier 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 Biological Qualifier is a potent tool on behalf of global public health.

The primacy of medicines quality

Over the last few years we have travelled to many countries around the world, visiting with medicines regulators from Australia, Europe, Latin America and the Middle East. Although a wide range of topics were discussed with these regulators, one of the most pressing issues for all was the urgency of access to quality medicine.

This paper will focus on medicines regulation in the Middle East and North Africa, specifically Algeria, Egypt, Iraq, Jordan, Kuwait, Lebanon, Morocco, Oman, Qatar, Saudi Arabia, Turkey and the United Arab Emirates (UAE). We will also discuss the importance of the World Health Organization’s leadership around establishing a global nomenclature policy that will help maintain the quality, safety and efficacy of biological and biosimilar medicines for that region.

Without quality, safety and effectiveness are non-starters and access is without meaning. Without quality, healthcare spending is not just wasteful – but harmful. Without quality it is all about ‘lowest price tenders’ without any consideration for value. Without quality, regulation is a sham.

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