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The event was attended by more than 400 participants from various backgrounds, including representatives from the West Java Provincial Health Office (Bahasa: Dinas Kesehatan Provinsi Jawa Barat), the Bandung branch of the National Agency of Drug and Food Control (Bahasa: Balai Besar POM (BBPOM) di Bandung), as well as leaders from several national pharmaceutical industries. It also brought together leaders of educational institutions, academics, and students from the ������Ƶ of Pharmacy and other universities across the Greater Bandung area. The public lecture was attended by ITB Rector Tatacipta Dirgantara, Director of Research and Community Service at the Directorate General of Research and Development, Ministry of Education, Culture, Research, and Technology (Kemendiktisaintek), I Ketut Adnyana. The event was opened by ITB Vice Rector for Academic and Student Affairs Irwan Meilano and moderated by ITB Directorate of Alumni Relation and Career Development, who is also a Professor at the ������Ƶ of Pharmacy, Sophi Damayanti.

In his lecture, the Head of BPOM RI highlighted the strategic potential of biosimilar products, which is defined as biological products that possess similar quality, safety, and efficacy as their originator counterparts. With technological advancements, approximately 65% of global pharmaceutical products today are biological products, while only 35% are still based on synthetic chemistry. As the prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes continues to rise, the demand for innovative therapies is increasing. Biosimilar products are considered capable of reducing treatment costs and expanding patient access to these therapies. Indonesia also has a large domestic market and strong human resource potential, particularly from higher education institutions that play a vital role in research and development.

As a form of commitment to supporting innovation, BPOM RI provides comprehensive assistance from the early research stage, through preclinical and clinical testing, to the registration process and post-marketing surveillance. Presidential Instruction No. 6 of 2016 serves as the foundation for accelerating the development of the pharmaceutical and medical device industries, further strengthened by the implementation of Good Manufacturing Practices (Bahasa: Cara Pembuatan Obat yang Baik, CPOB) and scientific data-based evaluations of product quality, safety, and efficacy.

Taruna also presented the potential for the development of biological products and Advanced Therapy Medicinal Products (ATMP) as part of the modern medical revolution. These cell- and gene-based therapies offer highly personalized and specific treatment approaches. BPOM RI has currently developed a regulatory framework for ATMPs in collaboration with the Ministry of Health to ensure their safety in Indonesia.

However, the Head of BPOM RI also highlighted significant challenges in the downstreaming of research results. These include the limited number of basic research studies that connect research objects to disease patterns, a lack of translational research and clinical development, and constraints in the regulatory approval process, such as with the FDA, which pose real barriers. To address these issues, Taruna emphasized the importance of connectivity and triple helix collaboration among academia, industry, and government. This public lecture also served as an interactive forum for discussion between regulators, academics, and industry players to explore concrete strategies for advancing pharmaceutical independence in Indonesia. Through triple helix collaboration, Indonesia is expected to strengthen its position in the development and production of competitive and high-quality biosimilar products that contribute to a more inclusive healthcare system.

Amid the rapid advancement of Artificial Intelligence (AI), the Head of BPOM RI also stressed that in the healthcare sector, particularly in the realm of biologics, AI can not replace human roles. The complexity and dynamics of the human body make pharmaceutical approaches impossible to fully automate. Therefore, the pharmaceutical sector continues to hold a long-term strategic role, including in the development of biosimilars and ATMPs. As a regulator, BPOM RI continues to foster a conducive innovation ecosystem through the development of adaptive regulations, harmonization of quality and safety standards, and integration of domestic products—including biologics and biosimilars—into the national procurement system. These efforts are expected to accelerate the growth of an independent and globally competitive national pharmaceutical industry.

In addition to delivering a scientific presentation, the Head of BPOM RI also visited several key facilities at the ������Ƶ of Pharmacy, including the Drug Delivery System Research Institute ITB–Daewoong Foundation, the Educational Pharmacy, and the Herbal Corner (Pojok Herbal). This visit was part of an ongoing effort to strengthen synergy between higher education institutions and regulatory bodies in building a sustainable national pharmaceutical research and innovation ecosystem.

Reporter: SF ITB
Translator: Indira Akmalia Hendri