Call for an ecosystem to boost biosimilar and vaccine production capacity

Bangladesh must move beyond its generic drug industry and develop capabilities in biologics, biosimilars, vaccines and other high-value medicines by building a comprehensive biopharmaceutical ecosystem, industry stakeholders said today (16 August).

They called for an integrated Life Science and Biopharmaceutical Strategy by 2035, focusing on technology transfer, clinical research, regulatory accreditation, shared infrastructure, and skilled workforce development.

The call came at a roundtable titled "From Generics to Biosimilars and Vaccines: Building Bangladesh's Biopharmaceutical Landscape en route to Bioeconomy", organised by BioTED and ZenX in Dhaka, sponsored by Somru BioScience.

Build full value chain, strengthen clinical research: Experts

In the keynote paper, Dr Munia Amin, MD and COO of GenX Health Ltd, said Bangladesh's pharmaceutical industry has built a strong foundation over the past few decades. But the global industry is rapidly shifting towards biologics, biosimilars, vaccines, recombinant proteins and monoclonal antibodies.

Bangladesh must therefore develop the entire value chain, from R&D and clinical trials to regulatory approval and advanced biological manufacturing, rather than focusing only on production, she said.

She called for international-standard clinical trial centres, trained investigators, GCP-compliant systems, data management, biostatistics, bioanalytical laboratories, and pharmacovigilance capabilities.

She also stressed strengthening the Directorate General of Drug Administration (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.

Mohammed Moin, CEO of Somru BioScience Inc, said Bangladesh needs to reduce its dependence on generic and small-molecule medicines and move rapidly towards biologics and biosimilars.

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 National Institute of Biotechnology through public-private partnerships to establish a biosimilar centre of excellence, training centre and reagent manufacturing facility.

He proposed a national programme 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.

Govt to formulate national strategy

The roundtable proposed some key policy measures: a 10-year National Strategy 2035 for biologics, biosimilars and vaccines; shared infrastructure for pilot manufacturing, advanced analytics and hands-on training; stronger regulation aligned with international standards to create market demand and help locally developed products reach regional and global markets.

Health State Minister MA Muhit said 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.

He said the sector's future is not only about healthcare and vaccines but also has significant potential for the national economy. 

The state minister said coordinated efforts by the government, industry, research institutions, universities and experts would be needed to advance the sector. He added that developing a knowledge-based economy would also create opportunities for high-skilled employment.

Dr Tahmeed Ahmed, executive director of icddr,b, said Bangladesh lacks the sequencing and bioinformatics expertise needed to develop biosimilars. 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 the 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 sector.

Dr Kazi Saifuddin Bennoor, director of the Bangladesh Medical Research Council, called for establishing a "brain circulation" system in research.