Regulatory Environment Changes for Biosimilars in 2025
Bangladesh's drug regulatory authority, the Directorate General of Drug Administration (DGDA), has been progressively strengthening its biosimilar regulatory framework since the second half of 2024. Previously, biosimilars could be registered through the same procedures as chemically synthesized generics — but the new guidelines introduce a dedicated Biosimilar Pathway as a separate registration route.
These changes were developed with reference to WHO and ICH (International Council for Harmonisation) guidelines, and now require comparability data, stability testing, and immunogenicity assessments. While the elevated regulatory standards raise short-term market entry barriers, they are expected to significantly enhance the international credibility of Bangladesh-manufactured biosimilars over the longer term.
WHO Pre-Qualification (PQ) Progress
WHO Pre-Qualification (PQ) is an essential certification for procurement by UN agencies such as UNICEF, the Global Fund, and GAVI — and represents the primary gateway for Bangladeshi pharmaceutical companies seeking access to the global biosimilar market. As of February 2025, approximately 8 biosimilar products from Bangladesh are pursuing WHO PQ certification, with 3 in the final review stage.
| Company | Product | Indication | Stage |
|---|---|---|---|
| Incepta | Insulin Glargine | Diabetes | Final review |
| Incepta | Trastuzumab | Breast cancer | GMP inspection completed |
| Square | Human Insulin | Diabetes | Final review |
| Renata | EPO Alfa | Anemia | Dossier submitted |
| Beacon | Insulin Aspart | Diabetes | GMP preparation |
| Square | PEG-GCSF | Neutropenia | Dossier preparation |
| Incepta | Rituximab | Lymphoma | CQS preparation |
| Healthcare | Human Insulin | Diabetes | GMP preparation |
Biosimilar Pricing Trends
Price competitiveness is one of the defining strengths of Bangladesh's biosimilar industry. Compared to originator products, Bangladeshi biosimilars are 60–80% cheaper — and even relative to Indian biosimilars, they maintain a 10–20% price advantage. This positioning reflects a convergence of low labor costs, the TRIPs waiver, and the government's relaxed pharmaceutical pricing regulation.
Regulatory Roadmap and Outlook
With WHO technical assistance, DGDA has established a roadmap to strengthen its biopharmaceutical regulatory capacity. The authority is targeting WHO NRA (National Regulatory Authority) Maturity Level 3 by 2027 — an achievement that would substantially raise the international credibility of Bangladesh-approved biosimilars.
Bangladesh's biosimilar regulatory environment is converging rapidly toward international standards. While this raises short-term registration costs and timelines, it creates a pathway to WHO PQ certification and global market entry — a far larger opportunity. Korean companies are well-positioned to participate in this transition through regulatory consulting, analytical services, and GMP equipment supply.