Drug shortages and supply-chain interruptions are not uncommon in many countries. This challenge has pushed pharmaceutical companies worldwide to develop generic drugs that can ensure continuity in treatment, especially for chronically ill patients.

In Lebanon, where drugs are mostly imported and compounded crises have further strained patients’ access to their medication, new hope came with the recent launch of the LAU Pharmaceutical and Medical Research Center (PMRC).

A pioneering undertaking by the university in collaboration with the Lebanese Ministry of Public Health and pharmaceutical and medical institutions, the center will contribute to the development of generic drugs by conducting tests that prove they share the same active ingredients as their brand-name counterparts—a process known scientifically as bioequivalence (BE) evaluation.

Wide-scale understanding of BE remains limited in Lebanon, however. To spread awareness on the topic, the School of Pharmacy held a professional development session titled Bioequivalence and Generic Drug Products: Scientific and Regulatory Considerations, presented by Dr. Sam Haidar, executive director of the PMRC. The session is one of a series of interactive events regularly hosted by the school’s Professional Development Committee and was open to healthcare experts, researchers and practitioners.

The presentation and following discussions furthered attendees’ knowledge of BE, drug absorption and bioavailability, components and the uses of BE studies, while offering a comprehensive overview of testing BE, and listing instances where in-vivo BE studies can be waived.

Dr. Haidar drew examples from his previous role as senior science advisor at the US Food and Drug Administration’s (FDA) Office of Study Integrity and Surveillance.

He asserted that generic drugs are not inferior to their brand-name counterparts because “they are subject to the same quality requirements, except that animal studies, clinical studies and bioavailability are all substituted by the bioequivalence study.” The latter, he explained, acts as a bridge to the data usually provided by these tests, which can be costly.

One of the topics presented during the session addressed commonly and persistently held misconceptions by the public as well as healthcare professionals about generic drugs and products.

“People think that generics are inferior just because they cost less, but it is safe to say that this is not true,” affirmed Dr. Haidar, explaining that generic drugs are subject to the same manufacturing and quality testing standards as the brand name drugs, but only cost less because they are not required to undergo repeated pre-clinical and clinical testing to demonstrate the safety and efficacy of the active ingredient.

Another common misconception claims that a generic drug’s active ingredient can differ in a margin of up to 20 percent from the brand name product. In fact, clarified Dr. Haidar, “it is almost impossible for a drug to differ by that extent and still pass BE testing.”

Backing this up with data, Dr. Haidar shared the results of two studies that demonstrated that generic products, approved over a nine-year period, differed by a negligible margin of less than four percent in the extent of absorption when compared to their brand-name counterparts, while also showing near-identical bioavailability in the test results. “This proves the high quality and therapeutic equivalence of generic drug products,” he said.

The session also featured case studies covering the methods and approaches used for different drug categories, as well as an overview of some examples of misconduct detected by the FDA.

The studies and data opened the door for more questions and insightful exchanges among attendees. The information presented and the discussions that followed helped demystify frequently misconceived facets of BE and generic drug products, contributing to a buildup of data-driven and publicly available content on the topic.

The full presentation is available here.