The biopharmaceutical industry is witnessing an inflection point with the growing prominence of biosimilars, therapeutic products that are highly similar to, and have no clinically meaningful differences from, existing reference biologics. In Southeast Asia, a region marked by diverse healthcare systems and economic disparities, biosimilars present an unprecedented opportunity to improve access to life-saving biologics. However, their successful integration into national formularies hinges on regulatory preparedness and harmonization.
As regional regulatory frameworks evolve, it’s critical for stakeholders—biopharma companies, regulatory strategists, healthcare providers, and policymakers—to understand both the commonalities and unique aspects of biosimilar regulation across Southeast Asia. In this blog, we explore the current state of biosimilar regulations in key ASEAN markets, the challenges they pose, and the strategies needed to foster a sustainable biosimilar ecosystem.
Why Southeast Asia Matters in the Global Biosimilar Strategy
With a combined population of over 650 million and rising demand for biologic therapies in oncology, autoimmune, and metabolic disorders, Southeast Asia is becoming a fertile ground for biosimilar adoption. As national healthcare expenditures grow and universal health coverage becomes a priority, biosimilars are seen as a cost-effective tool to expand access. However, regulatory fragmentation across countries creates bottlenecks in drug registration and market entry.
A Closer Look at the National Frameworks
Singapore
The Health Sciences Authority (HSA) follows stringent guidelines in line with global standards. It mandates that biosimilars be approved in reference jurisdictions (e.g., FDA, EMA, TGA) before local submission, treating unapproved biosimilars as new biological entities. This regulatory rigor ensures high quality but may lengthen time-to-market for developers without prior global approvals.
Malaysia
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) was among the first in ASEAN to issue biosimilar-specific guidelines (2008). NPRA aligns its evaluations with the ASEAN Common Technical Dossier (ACTD), focusing on comparability exercises and requiring substantial clinical and non-clinical evidence. To date, Malaysia has approved over 20 biosimilars, signaling both regulatory maturity and openness.
Thailand
Thailand’s FDA adopts a tailored regulatory approach, emphasizing product traceability and post-market surveillance. Unique identifiers like “NBS” help distinguish biosimilars from innovators, although interchangeability remains a grey area. The Thai market has seen slow but steady growth in biosimilar usage, particularly in oncology and rheumatology.
Indonesia, Philippines, and Vietnam
These markets are emerging players, with evolving biosimilar guidelines shaped by regional harmonization efforts and capacity-building partnerships. While approval timelines and dossier requirements are becoming clearer, regulatory reviews still face resource constraints and varying interpretations of comparability data.
The Challenge of Interchangeability
Perhaps the most contentious issue in Southeast Asia’s biosimilar landscape is interchangeability. While many regulators allow biosimilars to be used similarly to originator biologics, clear guidance on automatic substitution by pharmacists is largely absent. This creates uncertainty for prescribers and slows down adoption, even when products are clinically equivalent.
Physician education, payer alignment, and real-world evidence will be crucial in enabling a policy shift toward more confident use of biosimilars across therapeutic areas.
Harmonization Through ASEAN: A Work in Progress
Regional regulatory harmonization under the ASEAN Pharmaceutical Regulatory Framework (APRF) and ASEAN Common Technical Dossier (ACTD) offers a promising path forward. If implemented effectively, these initiatives can:
- Reduce duplication of regulatory reviews
- Enable mutual recognition of approvals
- Shorten biosimilar registration timelines
The long-term vision of an ASEAN Medicines Agency, akin to the European Medicines Agency (EMA), could revolutionize drug access in the region—but will require political will, investment, and infrastructure development.
Thought Leadership: Building a Biosimilar-Ready Future
For pharmaceutical companies, navigating this fragmented yet dynamic regulatory terrain demands a nuanced strategy:
- Early Regulatory Engagement: Establishing local relationships and understanding national expectations is key to smooth submissions.
- Tailored Dossier Preparation: Leveraging ACTD templates while customizing data per country-specific requirements is a winning approach.
- Capacity Building Support: Contributing to regulatory education and training programs positions companies as long-term partners, not just market entrants.
- Real-World Data Generation: Supporting local pharmacovigilance services and outcomes research can strengthen the case for broader biosimilar adoption.
Conclusion
Biosimilars are poised to play a transformative role in the healthcare systems of Southeast Asia. Yet realizing their full potential requires more than scientific equivalence—it calls for regulatory foresight, collaborative harmonization, and shared commitment from stakeholders across the region.
As Southeast Asia advances toward greater integration and health equity, those who proactively understand and shape the biosimilar regulatory ecosystem will lead the next frontier in affordable biologics.
About DDReg
DDReg is a global regulatory solutions provider with deep expertise in navigating complex regulatory landscapes for biosimilars across emerging and mature markets, including Southeast Asia. Leveraging a blend of scientific insight, regional regulatory intelligence, and strategic partnerships, DDReg supports biopharmaceutical companies in developing and executing tailored biosimilar registration strategies.
Read more from DDReg experts here: Pharmacovigilance Approaches for Biosimilars Market Success