BPOM Oversees Biosimilar Development and Export Expansion in Sidoarjo

The Food and Drug Authority (BPOM) has stated it is overseeing the progress of biosimilar technology development and processed food export expansion in Sidoarjo through monitoring and evaluation activities. BPOM Head Taruna Ikrar said in Jakarta on Thursday that his visit to PT Bernofarm and PT Sekar Laut Tbk demonstrated the agency’s commitment to providing layered protection for the public, while acting as an enabler that safeguards national pharmaceutical independence and food security in the global market. “BPOM has officially issued a Certificate of Good Manufacturing Practice (CPOB) for the drug substance and drug product facilities for PT Bernofarm’s biosimilar clinical trial products,” he said. In issuing the CPOB certificate, BPOM applies a strict supervision system from pre-market to post-market to guarantee product safety. Taruna emphasised that this rigorous oversight is the absolute responsibility of the regulator in protecting the public. “Our task is to ensure that all standard procedures are truly implemented. This supervision is not to complicate matters, but to protect. If a mistake occurs later, an investment of hundreds of billions could be lost and the public would become victims. Therefore, we are very serious in our oversight,” he stated. PT Bernofarm President Director Haryanto expressed gratitude for the support. “Thank you, Prof. Taruna, for your support from last year until now, and for taking the time to review the development of our facilities. We are also very grateful to have received the CPOB certificate for biosimilar products on a clinical trial scale last month. This is a major step forward for us to proceed to the next stage,” Haryanto said. BPOM subsequently inspected the processed food factory of PT Sekar Laut Tbk., a cracker producer with a production capacity of 25 tonnes per day that has obtained nine certificates for Good Processed Food Production Methods (IP CPPOB). Taruna explained that this food industry already exports to more than 30 countries and secured approval from the Saudi Food and Drug Authority (SFDA) in August 2025. The agency inspected the entire production line to ensure there are no gaps for harmful physical or chemical contamination. This monitoring step is mandated to maintain public health while fortifying the sustainability of local industry. “Our background is clear: ensuring safety and quality in public protection from pre-market to post-market. Export certificates are not just stamps; they are guarantees. Monitoring and evaluation are legally mandatory for us, not only to protect the public but also to protect the industry,” Taruna Ikrar explained regarding the visit. PT Sekar Laut Tbk Director Bambang said, “BPOM is a strategic partner for us, especially two years ago when we were processing an approval number for Saudi Arabia. Thanks to BPOM’s assistance, the permit was issued promptly. Alhamdulillah, the system is now online-based, and BPOM’s service shows very good progress.” Through this series of monitoring and evaluation visits, BPOM has demonstrated that internationally standardised strict supervision can synergise public health protection with strengthening the national economy. “BPOM’s presence at these drug and food production facilities ensures that products made by the nation’s children are safe for domestic consumption and have high competitiveness on the international stage,” he said.