March 07, 2025

Biological drugs have revolutionized the treatment of chronic and life-threatening conditions such as cancer, autoimmune diseases, and diabetes. However, their high cost imposes a significant financial burden on healthcare systems and patients alike. To address this challenge, biosimilars—biological medicines that closely resemble their reference biologics—have emerged as a cost-effective alternative without compromising quality, efficacy, or safety. The introduction of biosimilars has the potential to improve patient access to life-saving treatments while reducing healthcare expenditures.

Since the approval of Malaysia’s first biosimilar, somatropin, in 2010 by the National Pharmaceutical Regulatory Agency (NPRA), the adoption of biosimilars has steadily increased. However, regulatory compliance, clinical validation, and ongoing safety monitoring remain critical to ensuring their successful integration into the Malaysian healthcare system.

Regulatory Framework for Biosimilars in Malaysia

The NPRA, under the purview of the Ministry of Health Malaysia (MOH), is the primary regulatory authority responsible for evaluating and approving biosimilars. The agency introduced its biosimilar regulatory guidelines in 2008, aligning them closely with international standards set by regulatory bodies such as the European Medicines Agency (EMA), the World Health Organization (WHO), and the United States Food and Drug Administration (FDA). The regulatory framework emphasizes a rigorous comparative approach, requiring biosimilars to demonstrate similarity to their reference biologics in terms of quality, efficacy, and safety.

Key elements of Malaysia’s biosimilar regulatory pathway include:

  • A stepwise approach to biosimilar development, emphasizing physicochemical characterization, non-clinical evaluations, and clinical trials.
  • Comparative clinical trials to establish biosimilarity with the reference product.
  • Stringent pharmacovigilance and post-marketing surveillance requirements.

As of the latest NPRA records, 24 biosimilars have been approved across multiple therapeutic categories, with diabetes mellitus treatments comprising a significant portion of approvals. However, despite these regulatory advancements, approximately half of these biosimilars remain unavailable in the Malaysian market due to factors such as patent restrictions, pricing strategies, and market demand.

Local pharmaceutical manufacturers play a crucial role in biosimilar production and market expansion. Notable companies such as Biocon Malaysia and Duopharma Biotech Berhad contribute significantly to Malaysia’s biosimilar sector. Biocon specializes in recombinant human insulin and insulin glargine, while Duopharma focuses on erythropoietin, a key treatment for anemia in chronic kidney disease and chemotherapy-induced anemia.

Clinical Trials on Biosimilars in Malaysia

Clinical trials are essential in ensuring that biosimilars achieve comparable therapeutic effects as their reference biologics. Between 2010 and 2020, Malaysia conducted 10 phase III clinical trials evaluating biosimilar monoclonal antibodies, which are widely used in oncology and autoimmune diseases. These trials assessed efficacy, safety, and immunogenicity to confirm biosimilarity.

The Clinical Research Malaysia (CRM), a government agency under the Ministry of Health, plays a vital role in facilitating biosimilar clinical trials in the country. It collaborates with international pharmaceutical companies, contract research organizations (CROs), and local healthcare institutions to promote Malaysia as a hub for clinical research. The success of biosimilar trials in Malaysia highlights the country’s capability in supporting high-quality research and regulatory compliance for advanced biologic therapies.

Adverse Events and Safety Monitoring

Like all biological products, biosimilars carry the potential for immunogenic reactions and other adverse effects. To mitigate these risks, the NPRA enforces strict pharmacovigilance measures, requiring ongoing monitoring of biosimilar safety post-approval.

Between 2010 and 2020, NPRA recorded 499 adverse event (AE) reports related to biosimilars, with 43 cases (8.6%) classified as serious. Importantly, none of these cases resulted in fatalities. The most commonly reported adverse reactions were skin and subcutaneous tissue disorders, accounting for 33.8% of total reports. While these data indicate a favorable safety profile, limitations in adverse event reporting and biosimilar utilization data warrant further post-marketing studies and real-world evidence collection.

To enhance biosimilar safety monitoring, Malaysia follows global best practices in pharmacovigilance, including:

  • Implementation of Risk Management Plans (RMPs) to proactively address safety concerns.
  • Adverse drug reaction (ADR) reporting mechanisms through NPRA’s Malaysian Adverse Drug Reactions Advisory Committee (MADRAC).
  • Collaboration with healthcare professionals and industry stakeholders to ensure transparency and prompt identification of safety signals.

The Future of Biosimilars in Malaysia

With Malaysia’s stringent regulatory framework and increasing acceptance of biosimilars, the market is poised for further growth. The adoption of biosimilars is expected to enhance patient access to cost-effective biological treatments, encourage competition in the pharmaceutical industry, and contribute to the sustainability of healthcare expenditures.

Challenges such as market penetration, prescriber confidence, and public awareness remain critical areas for development. Continued investment in biosimilar research, robust regulatory oversight, and effective post-marketing surveillance will be key to ensuring long-term success. Additionally, keeping up with global biosimilar advancements and regulatory updates will help Malaysia remain competitive in this sector.

Conclusion

Biosimilars offer a promising solution to the growing demand for affordable biological treatments in Malaysia. With strong regulatory oversight, ongoing clinical research, and robust pharmacovigilance measures, the country is well-positioned to expand its biosimilar market. Overcoming challenges such as accessibility, awareness, and market penetration will be essential for maximizing the benefits of biosimilars and ensuring their long-term success in the Malaysian healthcare system.

How Maven Can Assist

For pharmaceutical companies looking to navigate Malaysia’s biosimilar landscape, Maven offers expert regulatory support, toxicology assessments, clinical research guidance, and pharmacovigilance services. Our team provides comprehensive assistance in biosimilar registration, compliance with NPRA regulations, and post-market safety evaluations.

Contact Maven today to explore tailored regulatory solutions and ensure seamless biosimilar market entry in Malaysia.