Bangladesh is at the cusp of redefining its pharmaceutical destiny. For decades, our strength lay in the manufacture and export of generic medicines. But that era, while fruitful, must now give way to something deeper, more complex, and globally competitive-biologics and biosimilars.
With the local pharmaceutical market set to hit USD6 billion by end-2025, and exports already crossing USD213 million in FY2024 25, it's time to evolve beyond replication. Biologics-large, cell-based, protein-based therapies like monoclonal antibodies, recombinant hormones, and cytokines-represent the next growth frontier. Globally, biologics are expected to surpass USD600 billion by 2030. If Bangladesh fails to act, it will miss this opportunity.
The most compelling sign of change comes not from a multinational, but from home. Globe Biotech Limited, headquartered in Dhaka, has already delivered what many thought impossible here-full-cycle biologics development, from cloned CHO mother cell to human trial success. Its biosimilar erythropoietin (GBPD002) passed bioequivalence tests (Cmax, Tmax, AUC), confirming global-standard development done fully within Bangladesh.
"Human capital is another challenge. Evaluating biologics involves far more than generic dossier review. It requires analytical similarity analysis, glycosylation profiling, immunogenicity testing, and PK/PD modeling. We need skilled reviewers, scientists, and regulatory officers trained in global regulatory science.”
This is not repackaging or toll-manufacturing under foreign tech transfers. It's in-house cell line development, bioreactor-based upstream expression, protein purification, aseptic fill-finish, and validated clean room processes-meeting ISO 5 to 8 air control standards. Globe's integrated biologics facility is the country's first, and it sets a high bar. With capability for monoclonal antibodies, fusion proteins, gene therapies, and cytokines, it proves we can go beyond copy-paste pharma and build global biopharma brands.
This achievement is not just a biotech milestone-it's a macroeconomic lever. Bangladesh currently enjoys a TRIPS waiver that allows patent-free production of biologics until November 2026. But time is running out. More than 600 biologics dossiers are pending at the Directorate General of Drug Administration (DGDA). Critical posts in the Drug Control Committee and technical subcommittees remain vacant. These gaps must be filled-immediately-or Bangladesh will miss the global biologics window.
Other firms are stepping up. Incepta is working on biosimilar erythropoietin and G-CSF. Beacon is producing biosimilar cancer drugs like bevacizumab and trastuzumab. Beximco is scaling insulin analogues. ZAS Corporation is importing and distributing licensed biosimilars. Yet only Globe has delivered true biopharmaceutical independence-from mother cell to vial.
But ambition must now meet infrastructure. The much-hyped API Industrial Park in Munshiganj remains incomplete. Core utilities, purified water, biosafety-rated warehousing, and cold-chain logistics are still under construction. Without these in place, biologics makers will keep depending on imported active ingredients-undermining cost advantage and strategic autonomy.
Critically, drugs could be priced 30-40 percent cheaper than imported alternatives, saving both foreign exchange and lives. Public health systems can negotiate bulk procurements. Patients battling cancer or kidney failure will gain access to world-class biologics-made in Bangladesh.
Let's be clear: Biologics are not just medicines. They are industrial commodities, healthcare diplomacy tools, and instruments of technological sovereignty. Bangladesh is no longer a passive player. It has made its first move. What we need now is a full-sector sprint-toward policy clarity, infrastructure readiness, talent pipelines, and export market access.
Globe Biotech has cracked the code. It's now the government's turn to scale that success.
Bangladesh has made the leap-from CHO cell line to global shelf. Let's not waste the moment.
The writer is former Senior Vice President of the Bangladesh Association of Pharmaceutical Industries (BAPI) and currently serves in biopharmaceuticals sector
