Biosimilar development key to strengthen national manufacturing: BPOM

Jakarta (ANTARA) - Indonesian Food and Drug Authority (BPOM) has said that strengthening the development of biosimilar products through investment, regulatory support, and enhanced scientific capacity is essential to improving Indonesia's manufacturing capabilities for biological products.

BPOM Head Taruna Ikrar said here on Wednesday that biosimilar products are biological products that are highly similar to, but not identical to, their reference biological products.

He said public confidence in biosimilars must be built through assurances of safety, efficacy, and quality, supported by scientific evidence.

He explained that Indonesia's biosimilar development ecosystem currently involves seven biosimilar manufacturers and 159 clinical trial sites.

This potential needs to be strengthened through sustained investment, enhanced scientific capacity, regulatory guidance, and alignment with international standards.

"Therefore, 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," Ikrar said.

In evaluating biosimilar products, BPOM applies a totality-of-evidence approach, drawing on international guidelines and applicable regulatory requirements.

This approach is in line with the WHO Guidelines on Evaluation of Biosimilars (WHO TRS 1043, Annex 3, 2022) and BPOM Regulation No. 17 of 2015 on Biosimilar Assessment Guidelines, which is currently undergoing revision.

Through this science-based approach, BPOM ensures that product registration decisions are based on compliance with safety, efficacy, and quality requirements, rather than on general product similarity alone.

"Currently, BPOM provides expedited evaluation pathways, with a review period 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.

Regulatory oversight does not end once a product receives marketing authorization. Post-marketing safety and quality monitoring remains necessary to identify potential risks and maintain public confidence in biosimilar products.

Ikrar said the development of Indonesia's domestic biosimilar industry also requires sustained collaboration, including through the Academia-Business-Government (ABG) approach.

Academia plays a role in driving innovation and strengthening research capacity, while industry is responsible for developing products and ensuring consistent quality. The government, meanwhile, ensures regulatory compliance and protects public health.

Synergy among all stakeholders is expected to strengthen Indonesia's domestic biological manufacturing capabilities while expanding public access to high-quality, safe, and effective biological products.

"Every license and approval I sign at BPOM is a step toward protecting human lives," Ikrar stressed in his message.

His statement underscored that efforts to strengthen the biosimilar industry and accelerate access to medicines must remain grounded in the protection of public health.

Meanwhile, Managing Director of Development Investment at Danantara Development Management Fund (DDMF) Rachmat Kaimuddin emphasized the importance of careful planning in developing Indonesia's national biosimilar industry.

He said several aspects require attention, ranging from raw material selection and production process supervision to financial management. He also highlighted the importance of stronger oversight to ensure that production processes are properly managed and controlled.

Meanwhile, Airlangga University Honorary Professor Carina Citra Dewi Joe stressed the importance of collaboration with BPOM in establishing a reliable quality management and standardization system.

These standards must be implemented comprehensively throughout the entire production chain, from upstream to downstream processes, including manufacturing and the quality of the resulting products, to support the development of high-quality biosimilars.

"To support the development of the biological products industry, the implementation of Good Manufacturing Practices (GMP) is essential to ensure consistent product quality from one batch to the next," she said.

"Manufacturers must ensure production process validation, contamination control, and the implementation of an adequate quality management system," she added.

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Translator: Mecca Yumna Ning Prisie, Katriana
Editor: Primayanti
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