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Pharmaceutical Industry: First Bioequivalence Study of a Drug Carried Out in Algeria

The Algerian bioequivalence center โ€œEquival Biocenterโ€ presented, on Sunday, in Algiers, its first bioequivalence study to demonstrate the therapeutic effectiveness of a generic antibiotic produced by the public pharmaceutical group โ€œSaidalโ€.

The presentation of this first study took place during a ceremony chaired by the Minister of Industry and Pharmaceutical Production, Ali Aoun, in the presence of the CEO of the Saidal Group, Wassim Kouidri, and the director of the center, Mourad Touati. , as well as executives from the industrial and health sectors.

On this occasion, Mr. Aoun underlined โ€œthe importance of carrying out this first bioequivalence study which concerned an antibiotic treatment, namely Amoxicillin, produced by the Saidal groupโ€.

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The launch of this first study marks, he specified during a press briefing, “the first step in the registration of therapeutic bioequivalence studies of a generic drug with the National Pharmaceutical Products Agency which requires this type of study for the registration of a drug to be marketed in Algeria.

โ€œThis bioequivalence center is a source of pride for the health sector and the national pharmaceutical industry. This is the first time that we are witnessing such an achievement thanks to our executives and young scientists,โ€ welcomed the Minister of Industry, assuring that โ€œthe activity of this center is essential and will make it possible to better protect Algerian patients by providing the necessary studies to prove that generic drugs are equivalent to reference drugs.

Mr. Aoun recalled in the same vein that the completion of this study was obtained after one year after the official inauguration of this center.

In this context, the Minister of Industry noted that the National Agency for Pharmaceutical Products has received to date more than 130 request files for bioequivalence studies, inviting the executives of the Bioequivalence Center to take charge of this demand by carrying out an average of 10 studies per month, to meet the demand expressed by manufacturers and professionals in the pharmaceutical sector.

The minister also announced that the services of the Ministry of Industry and Pharmaceutical Production had recently granted new approval for the opening of a second center of this type, while another request is in progress. examination for the award of a third accreditation.

During this presentation, Mr. Aoun inspected the various services and facilities of this center where he received detailed presentations on the process of carrying out bioequivalence studies at this establishment equipped with modern facilities and infrastructure, including one important clinical unit, allowing it to guarantee quality and consistent results.

According to the center’s director, Mr. Touati, the first bioequivalence study of the โ€œSaidalโ€ treatment was conducted during October on around thirty volunteers who were hosted for three days within the clinic.

The results were satisfactory and conclusive as to the effectiveness of this drug on the people tested,โ€ said Mr. Touati, specifying that all material and support resources were made available to the volunteers.

According to him, the completion of this study marks โ€œa significant step in the development of the pharmaceutical industry in Algeria.โ€

While explaining that bioequivalence studies are essential for the registration of generic drugs, he assured that the Equival Biocenter’s activity will strengthen โ€œthe local capacities of national pharmaceutical laboratories to have access to global markets.โ€

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