Jakarta, INTI - Indonesia’s National Agency of Drug and Food Control (BPOM) is encouraging the development of biosimilar products through increased investment, stronger regulatory frameworks, and enhanced research capabilities. The initiative aims to strengthen the country’s domestic biopharmaceutical manufacturing industry while expanding public access to safe, high-quality medicines.

BPOM Head Taruna Ikrar stated that Indonesia has significant potential for biosimilar development, supported by seven biosimilar manufacturers and 159 clinical trial sites.

According to Taruna, this potential needs to be further developed through sustainable investment, stronger scientific capabilities, regulatory assistance, and alignment with international standards.

He delivered the statement in Jakarta on Wednesday, November 4, 2026, highlighting efforts to strengthen Indonesia’s biopharmaceutical development ecosystem.

BPOM Emphasizes Biosimilar Safety and Quality Standards

Taruna explained that biosimilars are biological products that are highly similar to an existing reference biological product, although they are not entirely identical.

Therefore, biosimilar development requires comprehensive scientific evaluation to ensure product safety, efficacy, and quality before they are made available to the public.

"Consequently, biosimilar evaluation requires a comprehensive approach covering analytical characterization, functional testing, pharmacokinetics and pharmacodynamics, immunogenicity, as well as clinical data, as necessary to demonstrate product comparability," Taruna explained.

BPOM applies the totality of evidence approach when assessing biosimilar products. This method requires evaluations to consider a wide range of scientific evidence rather than relying solely on general similarities between products.

According to BPOM, marketing authorization decisions must be based on compliance with safety, efficacy, and quality requirements.

The evaluation process follows the World Health Organization (WHO) guidelines for biosimilar assessment outlined in WHO Technical Report Series (TRS) 1043, Annex 3, published in 2022.

In addition, BPOM refers to BPOM Regulation No. 17 of 2015 concerning Guidelines for Biosimilar Assessment, which is currently undergoing revision.

BPOM Introduces Accelerated Drug Evaluation Pathways of Up to 50 Working Days

To support the development of Indonesia’s pharmaceutical industry, BPOM provides several accelerated drug evaluation pathways based on applicable categories and regulatory mechanisms.

"Currently, BPOM offers an accelerated evaluation pathway of 50 working days for new drug development and investment in Indonesia, 90 working days through the reliance mechanism, and 100 working days for certain drug categories in accordance with applicable regulations," he said.

The reliance mechanism allows regulatory authorities to consider assessments conducted by other regulatory agencies as part of their evaluation process, subject to applicable requirements.

Taruna emphasized that accelerating the evaluation process does not eliminate the obligation to ensure product safety, efficacy, and quality.

BPOM also maintains post-marketing surveillance after drugs receive marketing authorization, including ongoing monitoring of their safety and quality.

This monitoring is essential for identifying potential risks that may emerge after products are used by the public.

According to BPOM, continuous supervision plays an important role in building public confidence in biosimilar products developed and marketed in Indonesia.

Seven Biosimilar Manufacturers and 159 Clinical Trial Sites Support Industry Development

Taruna stated that the presence of seven biosimilar manufacturers and 159 clinical trial sites provides a strong foundation for Indonesia to strengthen its domestic biopharmaceutical manufacturing capabilities.

However, further industry development requires sustainable collaboration among universities, businesses, and the government.

BPOM encourages the Academia–Business–Government (ABG) collaboration model to strengthen the ecosystem for biosimilar research, development, manufacturing, and regulatory oversight.

Under this approach, academic institutions contribute to innovation and the advancement of research capabilities.

Meanwhile, industry players are responsible for product development and maintaining consistent quality throughout the manufacturing process.

The government plays a role in ensuring regulatory compliance while safeguarding public health.

Taruna stressed that patient safety must remain the top priority in biosimilar industry development.

"Every license and approval I sign at BPOM represents a step toward protecting human life," Taruna Ikrar emphasized.

Danantara Highlights the Importance of Biosimilar Production Planning and Oversight

Rachmat Kaimuddin, Managing Director of Development Investment at Danantara Development Management Fund (DDMF), highlighted the importance of proper planning in developing Indonesia’s domestic biosimilar industry.

According to Rachmat, several aspects must be considered from the outset, including raw material selection, manufacturing process supervision, and financial management.

He noted that strengthening oversight systems is necessary to ensure manufacturing activities are conducted in a structured and controlled manner.

Such planning is part of broader efforts to establish a biosimilar industry capable of meeting production needs while maintaining consistent product quality.

Airlangga University Expert Stresses Strict Pharmaceutical Manufacturing Standards

Carina Citra Dewi Joe, Honorary Professor at Airlangga University, emphasized the importance of collaboration between pharmaceutical manufacturers and BPOM in establishing quality management systems and standardizing biosimilar products.

According to Carina, standards must be implemented comprehensively, from the initial development stages through manufacturing and final product inspection.

She highlighted the importance of implementing Good Manufacturing Practices (GMP), known in Indonesia as Cara Pembuatan Obat yang Baik (CPOB), to ensure consistent quality in biological products.

"To support the development of the biopharmaceutical industry, the implementation of Good Manufacturing Practices (GMP) is essential to ensure consistent product quality from one production batch to another. Manufacturers must ensure production process validation, contamination control, and the implementation of adequate quality management systems," she stated.

Carina believes that a robust quality management system is necessary to ensure that every production batch meets established standards.

BPOM hopes that stronger collaboration among the government, academia, and industry will enhance Indonesia’s domestic biopharmaceutical manufacturing capabilities and expand the availability of safe, effective, and high-quality biosimilar products for the public.

Conclusion 

Indonesia is strengthening its biosimilar industry through increased investment, regulatory improvements, and research collaboration. With seven biosimilar manufacturers and 159 clinical trial sites, the country has significant potential to expand domestic biopharmaceutical production, reduce reliance on imported medicines, and improve public access to safe, high-quality treatments.

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