Insights and Takeaways: Key Highlights from Each Speaker at PT Biometrik Riset Indonesia's Focus Group Discussion on Bioequivalence Testing

Writer and Editor : Denia Zalfaa Marwaa Evangeulista

Jakarta, October 30, 2024 – PT Biometrik Riset Indonesia hosted a Focus Group Discussion (FGD) titled “The Impact of Formulation on Bioequivalence Testing: Ensuring the Interchangeability of Generic and Innovator Drugs” at Hotel Borobudur, Jakarta. The event brought together experts and stakeholders from the pharmaceutical sector to address the challenges and opportunities in ensuring bioequivalence between generic and innovator drugs, thereby enhancing access to safe, effective, and affordable medications in Indonesia.

Keynote Address by Mr. F. Tirtokoesnadi, MBA

The FGD commenced with a keynote speech by Mr. F. Tirtokoesnadi, MBA, Chairman of the Indonesian Pharmaceutical Companies Association (GPFI). Mr. Tirtokoesnadi emphasized the critical need for continuous improvement in BE testing to guarantee the availability of safe, effective, and affordable generic drugs in Indonesia.

Speaker Highlights and Key Takeaways

1. Mr. Roy Himawan, S.Farm, Apt, M.K.M - Ministry of Health Republic Indonesia

Mr. Roy Himawan, Director of Pharmaceutical Resilience and Medical Devices at the Ministry of Health, presented on “Strategies for Enhancing Healthcare Resilience through Domestic Product Independence”. In his presentation, Mr. Roy highlighted several key points regarding the Ministry of Health's efforts to strengthen Indonesia's healthcare system. First, through the six pillars of Health Transformation, the Ministry has developed the National Health Architecture, which aims to optimize local potential and innovation in line with the national vision, Asta Cita 4. He also emphasized the role of Health Law No. 17 of 2023 and Government Regulation No. 28 of 2024 in reinforcing the healthcare system by maximizing domestic innovation, particularly in the pharmaceutical and medical device sectors, to enhance national resilience. Lastly, Mr. Roy called on all stakeholders—government, the private sector, industry, and international organizations—to collaborate in improving local research and development (R&D) and manufacturing capacity, in order to strengthen Indonesia's overall healthcare resilience.

2. Dr. Ria Christine Siagian, S.Si., Apt., M.Sc - The Indonesian Food and Drug Authority (BPOM)

Dr. Ria Christine, Director of Drug Registration at BPOM, delivered a presentation on “Regulation and Compliance in BE Testing under KEPKA 200 Mandatory BE Molecules.” Dr. Ria Christine Siagian highlighted that BPOM ensures all drugs meet regulatory standards before reaching the market. This pre-market oversight includes thorough assessments of efficacy, safety, and quality for generic drugs by confirming their therapeutic equivalence to innovator drugs. Through bioequivalence testing, BPOM guarantees that generic drugs receiving distribution licenses (NIE) are interchangeable with their innovator counterparts in terms of quality, efficacy, and safety.

3. Prof. Dr. apt. Yeyet Cahyati Sumirtapura, DEA - Academic Expert

Prof. Dr. apt. Yeyet Cahyati Sumirtapura, DEA, emeritus professor from the School of Pharmacy, Institut Teknologi Bandung, delivered a presentation on “Formulation Components: Raw Material Specifications, Excipients, Manufacturing Techniques, and Their Impact on Stability and Biopharmaceutics.” Prof. Yeyet Cahyati Sumirtapura explained that achieving a stable, bioequivalent formulation can involve multiple approaches, with the choice of method varying based on each drug's specific physical and chemical properties, therapeutic dose, and available production facilities. In some cases, a combination of techniques may be necessary to ensure bioequivalence. However, he emphasized that dissolution similarity alone does not guarantee bioequivalence without a strong in vitro-in vivo correlation, as this depends on the characteristics of the active ingredient and its Biopharmaceutics Classification System (BCS) class. Additionally, certain modifications in biopharmaceutical processes, such as enhancing solubility and absorption, can simultaneously improve the stability of the active ingredient in the formulation.

4. apt. Dra. Effi Setiawati, M. Biomed. - Bioequivalence Study Expert

Ms. Effi Setiawati’s, Operational Director of PT Biometrik Riset Indonesia, delivered a presentation on “In Vitro-In Vivo Correlation (IVIVC) in Formulation Development”. Ms. Effi Setiawati explained that In Vitro-In Vivo Correlation (IVIVC) is a valuable tool for predicting the pharmacokinetic profile of the dissolution of solid oral dosage forms. Based on the Biopharmaceutics Classification System (BCS), IVIVC can be predicted for most products, except for modified-release formulations such as enteric-coated, sustained-release, and extended-release drugs. To minimize the risk of failed bioequivalence (BE) studies, she recommended conducting pilot studies for modified-release products and certain BCS Class 4 molecules, as IVIVC can be unpredictable in these cases.

5. Mr. apt. Arief Kurniawan, S. Farm - PT Kimia Farma Tbk

Mr. Arief Kurniawan from PT Kimia Farma Tbk shared a success story on the bioequivalence testing journey for a combination drug (Tenofovir-Lamivudine-Efavirenz). He highlighted critical aspects in drug development, including preformulation studies focusing on API and comparator drugs, formulation adjustments based on excipients, and strategic alignment with BCS classifications. His session provided practical insights into overcoming challenges in bioequivalence testing and formulation development.

Summary and Conclusion

The Focus Group Discussion (FGD) shed light on the importance of BE testing and formulation considerations to ensure high-quality, interchangeable generic drugs. The collaboration among regulators, industry, and academia will be essential for implementing advancements in bioequivalence standards and pharmaceutical resilience in Indonesia.