Biological products are one of the focuses of independence targeted by the Ministry of Health. This is because the development of medicine has now turned to biotechnology products, the need in health services is quite large, plus the price of these products is also quite high.

The significant value of biological products can be seen from the market potential that has been recorded. Based on IQVIA market research data in 2021, the volume growth rate of biological products (especially immunology and oncology) for the 2016-2020 period reached 83%, the highest among other therapeutic class products. KF data also confirms that biological products are predicted to dominate the top 100 sales products globally (55%) in 2026, far surpassing the similar condition in 2012 (16%). Indonesia needs to capitalize on this potential, especially considering that several biological product molecules will enter the off-patent period in the next 3 years.

In 2022, 4 biological products have been targeted to be developed domestically, namely EPO, insulin gargline, enoxaparin, and rituximab which will then be achieved by 10 products in 2024 (cumulative). In realizing independence in the field of biotechnology, close synergism between the Government, industry, researchers and universities / higher education institutions is needed. One of them requires adequate testing laboratory support, both for research and QC release testing. Indonesia already has various research and testing laboratories, but there are still some tests carried out abroad such as protein characterization testing and invivo in animals.

In an effort to synergize steps in mapping the capacity of research and testing laboratories in Indonesia, the Directorate of Pharmaceutical and Health Security held a Central Facility Mapping of Biological Product Testing on Monday, October 24, 2022 at the Royal Hotel Jakarta, with participants consisting of the pharmaceutical industry that has and will develop biological products, Ministry of Health participants, Research Institutions, BPOM and BRIN.

In his report, the Head of the Working Team for Development and Facilitation of Downstreaming of Raw Materials and Preparations of Phytopharmacia and Domestic Biological Products, Refiandes said that this activity aims to determine the ability/capacity of existing test laboratories and explore the formation of a central network/facility for testing biological products in Indonesia.

Director of Pharmaceutical Security and Medical Devices, Roy Himawan had the opportunity to give directions as well as officially open this activity. The Director said that it is necessary to map the capacity of laboratories that have or have not been ISO/GLP certified. Henceforth, a network or joint laboratory facilities (RnD, QC, Preclinical) that meet the standards can be developed to support pharmaceutical independence. In addition, with Indonesia producing biotechnology products, Indonesia can compete with other countries that are more “advanced” in biotechnology products. “My hope is that the technology and quality of biotechnology products produced by Indonesia can compete so that they can be equal or even superior to foreign products,” Himawan concluded.

The biological industry players feel very helpful with this forum where data on the capacity of existing test laboratories in Indonesia can be obtained and recommendations for follow-up plans to be made by stakeholders related to efforts to establish a network of biological product test laboratories in Indonesia.

Efforts to accelerate the development of biology cannot be separated from the ability of laboratory capacity in terms of research and testing, for this reason cooperation is needed from all parties both from the Government, Academics / Research Institutions and Industry. Laboratory inventory both in terms of facilities and testing capacity, laboratory certification and improvement of human resources capabilities in terms of research and testing are needed in this improvement effort.