Bangladesh Unveils National Strategy to Build Biopharmaceutical Ecosystem for Biosimilars and Vaccines
核心洞察
Bangladesh's government announced it will formulate a national strategy to advance the pharmaceutical industry toward biosimilars (搜索), vaccines (搜索), and biotechnology, moving beyond its generic drug base.
Industry stakeholders called for an integrated Life Science and Biopharmaceutical Strategy by 2035, emphasizing technology transfer, clinical research, regulatory accreditation, and workforce development.
The transformation will require roughly 10,000 trained professionals, with proposals for shared infrastructure, a biosimilar center of excellence, and strengthened regulatory capacity aligned with international standards.
Bangladesh must move beyond its generic drug industry and develop capabilities in biologics, biosimilars (搜索), vaccines (搜索), and other high-value medicines by building a comprehensive biopharmaceutical ecosystem, industry stakeholders said on 16 August at a roundtable in Dhaka. The event, titled "From Generics to Biosimilars and Vaccines: Building Bangladesh's Biopharmaceutical Landscape en route to Bioeconomy," was organized by BioTED and ZenX and sponsored by Somru BioScience (搜索).
State Minister for Health and Family Welfare Dr MA Muhit announced that the government would initiate a national strategy for the biopharmaceutical, clinical research, and biotechnology sectors to take Bangladesh's pharmaceutical industry to the next level. "The government is committed to building a knowledge-based economy and will provide all necessary policy support for the development of the sector and creation of high-quality employment," he said.
Building the Full Value Chain
In the keynote paper, Dr Munia Amin, MD and COO of GenX Health Ltd (搜索), said Bangladesh's pharmaceutical industry has built a strong foundation over the past few decades, but the global industry is rapidly shifting toward biologics, biosimilars (搜索), vaccines (搜索), recombinant proteins, and monoclonal antibodies (搜索). She argued that Bangladesh must develop the entire value chain—from R&D and clinical trials to regulatory approval and advanced biological manufacturing—rather than focusing only on production.
Dr Amin called for international-standard clinical trial centers, trained investigators, GCP-compliant systems, data management, biostatistics, bioanalytical laboratories, and pharmacovigilance capabilities. She also stressed strengthening the Directorate General of Drug Administration (搜索) (DGDA) to establish a credible regulatory system aligned with international standards. To address the skills gap, she proposed hands-on training in biotechnology, molecular biology, cell culture, bioprocess engineering, GMP, quality control, and clinical research.
A 2030–2035 Strategy and Workforce Development
Mohammed Moin, CEO of Somru BioScience (搜索) Inc, said Bangladesh needs to reduce its dependence on generic and small-molecule medicines and move rapidly toward biologics and biosimilars (搜索). He called for a 2030 Life Science and Biopharmaceutical Strategy and said gaps in cell-line development, advanced analytics, clinical development, and regulatory capacity could be addressed through technology-transfer partnerships with institutions and companies in technologically advanced countries.
Moin proposed using existing infrastructure at institutions such as the Bangladesh Council of Scientific and Industrial Research and the National Institute of Biotechnology through public-private partnerships to establish a biosimilar center of excellence, training center, and reagent manufacturing facility. He also proposed a national program to provide hands-on training to around 10,000 professionals over the next two years to address the shortage of technical expertise in the sector.
The roundtable proposed key policy measures, including a 10-year National Strategy 2035 for biologics, biosimilars (搜索), and vaccines (搜索); shared infrastructure for pilot manufacturing, advanced analytics, and hands-on training; and stronger regulation aligned with international standards to create market demand and help locally developed products reach regional and global markets.
Clinical Research Capacity and Scientific Gaps
Dr Tahmeed Ahmed, executive director of icddr,b, said Bangladesh lacks the sequencing and bioinformatics expertise needed to develop biosimilars (搜索). He noted that if a biosimilar is proven as effective as the original drug, an adaptive trial approach could help complete clinical trials faster. "Trust and track record are the most important factors in advancing clinical research in Bangladesh," he said, adding that icddr,b's extensive research experience and capacity to conduct more than 100 vaccine trials could be leveraged.
Dr Syed Abdul Hamid, professor at the Institute of Health Economics at Dhaka University, called for a central laboratory and animal house, a strong CRO ecosystem, one-stop regulatory approval services, and more biostatisticians to support the biologics and biosimilars (搜索) sector. Dr Kazi Saifuddin Bennoor, director of the Bangladesh Medical Research Council, called for establishing a "brain circulation" system in research.
Government Commitment and Economic Vision
Dr Muhit said the country's pharmaceutical sector has developed through a long historical process. "This is the time to transform it into advanced areas such as biosimilars (搜索), vaccines (搜索) and biotechnology. It cannot be viewed solely from the perspective of health security; rather, it must be seen through the lens of the bio-economy as a major driver of the national economy," he said.
He said that within the next 3-5 years, the country must establish basic infrastructure for biopharmaceutical and vaccine research maintaining proper quality and international standards. The new transformation will require around 10,000 trained and skilled human resources, and the government is prioritizing not only general employment but also high-end employment centered on science and research.
The state minister said Contract Research Organizations (CROs) will be established and the country's own research capacity in biosimilars (搜索) will be strengthened. He also assured that government initiatives would be taken to establish "shared facilities" or centralized laboratory facilities for industry entrepreneurs and researchers. On opportunities for young researchers, he said practical measures have been taken to strengthen the capacity of research institutions through the health sector budget, establish molecular biology laboratories, and increase open and competitive research funding for young researchers through the Ministry of Science and Technology.