PT Biometrik Riset Indonesia Hosts Successful Focus Group Discussion “The Impact of Formulation on Bioequivalence Testing: Ensuring the Interchangeability of Generic and Innovator Drugs”

Writer and Editor : Denia Zalfaa Marwaa Evangeulista

Event Summary:

• Date: Wednesday, October 30, 2024
• Time: 08:30 – 16:00 WIB
• Location: Hotel Borobudur Jakarta (Jl. Lapangan Banteng Selatan No.1, Pasar Baru, Sawah Besar District, Central Jakarta, DKI Jakarta 10710)

Jakarta, October 30, 2024 – PT Biometrik Riset Indonesia proudly hosted a focused and productive day of discussions at its recent Focus Group Discussion (FGD) titled “The Impact of Formulation on Bioequivalence Testing: Ensuring the Interchangeability of Generic and Innovator Drugs”. This timely gathering of Indonesia’s top pharmaceutical regulators, experts, and industry representatives spotlighted the vital link between formulation practices and bioequivalence (BE) testing – as well as the strategies necessary for maintaining high standards in generic drug interchangeability.

Event Highlights

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

In the first session, moderated by Mrs. apt. Dra. Effi Setiawati, M. Biomed., Operational Director of PT Biometrik Riset Indonesia, experts from Ministry of Health Republic Indonesia and the Indonesian Food and Drug Authority (BPOM) presented on pivotal topics:

• Mr. Roy Himawan, S.Farm, Apt, M.K.M, Director of Pharmaceutical Resilience and Medical Devices, Ministry of Health, discussed “Strategies for Enhancing Healthcare Resilience through Domestic Product Independence”.
• Dr. Ria Christine Siagian, S.Si., Apt., M.Sc, Director of Drug Registration at BPOM, provided insights on “Regulation and Compliance in BE Testing under KEPKA 200 Mandatory BE Molecules”.

The second session, moderated by Mr. Andi Darmawan, Technical Manager of PT Biometrik Riset Indonesia, featured presentations from leading formulation experts:

• Prof. Dr. apt. Yeyet Cahyati Sumirtapura, DEA delivered insights on “Formulation Components: Raw Material Specifications, Excipients, Manufacturing Techniques, and Their Impact on Stability and Biopharmaceutics”.
• apt. Dra. Effi Setiawati, M. Biomed. provided insights on “In Vitro-In Vivo Correlation (IVIVC) in Formulation Development”.

The sessions fostered vibrant discussions, with participants actively engaging during the Q&A sessions.

The day also included a Sharing Session Success Story on the bioequivalence testing of the Tenofovir-Lamivudine-Efavirenz combination, presented by Mr. apt. Arief Kurniawan, S. Farm. from PT Kimia Farma Tbk. His insights on product development and formulation were especially valuable to attendees.

Closing Remarks and Survey Feedback

The event concluded with an exciting raffle, with six door prizes awarded to lucky participants. A post-event satisfaction survey revealed overwhelmingly positive feedback, with attendees rating the event as highly beneficial, informative, and well-organized. Several participants recommended making this Focus Group Discussion (FGD) as an annual event, underlining its importance for advancing bioequivalence testing knowledge and practice in Indonesia.

PT Biometrik Riset Indonesia remains committed to fostering collaboration among regulators, academia, and industry, ensuring Indonesia’s generic drugs meet the highest standards of safety, quality, and interchangeability.