Saturday, July 13, 2024

Generic Medicines and Biosimilars Take Center Stage at Tunisia’s Inaugural International Days

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The Tunisian Association of Generic Medicines, in collaboration with the Ministry of Health, organized the First International Days of Generic Medicines and Biosimilars in May. This landmark event highlighted the advancements and challenges in the development of generic and biosimilar drugs both in Tunisia and globally.

The plenary session commenced with a comprehensive review of Tunisia’s policy and progress regarding generic and biosimilar drugs. Notably, Tunisia granted its first biosimilar drug authorizations in 2002, preceding the USA, which began in 2015-2016. Despite this early start, Tunisia’s biosimilar production has lagged due to high production costs, pushing the focus towards more affordable generic medicines to ensure broader access.

Professor Abderrazek Hedhili, Director General of the National Agency for Medicines and Health Products, emphasized the slow progress in the biosimilar sector, attributing it to limited resources. However, he also noted a recent proposal to establish a specialized biosimilar company in Tunisia, indicating growing interest and potential for sectoral development. He highlighted the country’s ongoing commitment to bioequivalence, pharmacovigilance, and laboratory creation to support generic and biosimilar drug quality.

Leveraging Tunisia’s Workforce and Unified Efforts in the MENA Region for Biosimilar Advancements

Hedhili stressed the importance of leveraging Tunisia’s skilled workforce in biosimilar production. He called for national policy support to retain these professionals and foster their development, thereby enhancing the local biosimilar industry. Additionally, he urged Tunisia to prioritize biosimilars for treating serious and chronic diseases and to establish a single council for drug price review.

At the regional level, the performance of MENA countries in biosimilar production remains uneven due to a lack of unified efforts. Mr. Abdelnaceur Sijari, president of the Arab Union of Producers of Medicines and Medical Products, revealed that the Arab region has about 795 pharmaceutical industries. He advocated for a common market to reduce healthcare costs, especially with the rise of chronic diseases and cancers treatable by biosimilars. Addressing existing sectoral shortcomings is crucial for this progress.

The event also underscored the necessity of raw material availability for biosimilar production, manufacturer encouragement, and the establishment of a unified Arab market. Increased investment in scientific research and budget enhancements for the sector were recommended. According to Sijari, the high cost of biosimilar treatment—estimated at around $100,000 per patient—underscores the need for such investments.

Generic Medicines

Stringent Regulatory Frameworks Essential for Generic Medicines and Biosimilars, Experts Assert

Professor Fernando De Mora, a pharmacology specialist and biosimilar consultant, highlighted the regulatory differences between generic and biosimilar drugs. He pointed out the complexity of biosimilar molecules, which necessitates distinct and stringent regulatory frameworks compared to simpler generic drugs. The European Medicines Agency (EMA) insists on rigorous regulations to stimulate market growth, emphasizing that undemanding regulations could lead to sub-standard products.

De Mora concluded that producing and re-producing biological drugs requires extensive confirmation of clinical equivalence, including comparability studies, active pharmacovigilance, and clinical trials. He called for global regulatory convergence, supported by the EMA, to ensure high standards in biosimilar production and regulation.

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The event underscored Tunisia’s commitment to advancing the generic and biosimilar sectors, recognizing the need for robust policies, investment, and international collaboration to overcome current challenges and harness the full potential of these vital medicines.


We would like to extend our sincere thanks to Amir Mustapha Sharaf for writing this insightful article and sharing his valuable expertise.

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