Biometrik Completed Successful Bioequivalence Studies for Ministry of Health Projects 2025

Writer: Devita Nurul Anggraeni Editor: Oktaviani Utami Dewi

Jakarta, December, 22 2025 - PT Biometrik Riset Indonesia has completed bioequivalence studies and reported the results for four molecules on behalf of twelve pharmaceutical industries participating in the Ministry of Health’s Facilitation Program for Local Change of Active Pharmaceutical Ingredient (API) sources. The completed molecules include Sitagliptin, Sitagliptin–Metformin, Rivaroxaban, and Imatinib, covering a total of twelve projects: seven Sitagliptin projects, one Sitagliptin–Metformin project, three Rivaroxaban projects, and one Imatinib project. All bioequivalence study results confirmed that the test products were bioequivalent to their respective comparator products in terms of both the rate and extent of absorption. The studies and reporting were completed ahead of the established deadlines, with study reports submitted to the Ministry of Health of the Republic of Indonesia and the participating pharmaceutical companies on December 4th, December 16th, and December 22nd, 2025. All studies were conducted in compliance with BPOM Bioequivalence Guidelines and the European Medicines Agency (EMA) requirements, including relevant GCP and GLP standards.

With the increasing prevalence of diabetes, blood coagulation disorders, and cancer, the demand for affordable and effective generic medicines is growing. As a Contract Research Organization (CRO), PT Biometrik Riset Indonesia remains committed to conducting bioavailability and bioequivalence (BA/BE) studies to support government programs that ensure the distribution of safe and reliable generic medicines. The availability of generic medicines demonstrated to be bioequivalent to reference products is expected to enhance public access to high-quality medicines across Indonesia.