Policy & Advocacy
Generics and Biosimilars
Affordable Medicines. Accessible Healthcare.
Sustainable Supply.
Generics and biosimilars form the backbone of Malaysia’s pharmaceutical supply, accounting for over 70% of prescription medicines consumed by volume. These affordable alternatives to originator medicines meet the same rigorous quality, safety, and efficacy standards whilst being significantly lower in cost—enabling broader patient access to essential treatments across both public and private healthcare sectors.
What Are Generics and Biosimilars?
Generic medicines
Generic medicines are pharmaceutical products that contain the same active ingredient and are approved at the same strength(s), dosage form, and route of administration as the original medicine, and are required to undergo Bioequivalence clinical studies to proof identical efficacy as the original medicine. In addition, NPRA ensures that Generic medicines meet the same standards of quality and safety.
Biosimilars
Biosimilars are biological medicines that are highly similar to an approved reference biologic product, and have been demonstrated to have comparable quality, safety, and effectiveness, based on Clinical studies and rigorous regulatory evaluation.
Why Generics and Biosimilars Matter
Patient Affordability
Improving affordability and access to essential treatments for patients.
Healthcare Sustainability
Supporting healthcare system sustainability by optimising medicine expenditure.
Medicine Security
Enhancing supply security through diversified and local manufacturing capacity.
Expanding Treatment Options
Enabling broader patient access to therapies, including complex and biologic medicines.
As demand for medicines continues to grow, particularly for chronic and non-communicable diseases, generics and biosimilars remain central to balancing innovation, access, and sustainability.
Role of Local Pharmaceutical Manufacturing
Backbone of Medicine Supply
Local manufacturing forms the foundation of Malaysia’s medicine supply
Supporting Continuity and Affordability
Local manufacturing supports a stable and affordable supply of essential medicines
Expanding Access to Medicines
Local manufacturing helps widen access to generics and biosimilars across Malaysia
Promoting Access to Generics and Biosimilars
2024 Snapshot
RM13.1 billion
Pharmaceutical market value, growing 10.9% from previous year
Over 80%
of generic and biosimilar medicines consumed in the country were locally produced by volume
Over 50%
of prescription medicines in Malaysia were supplied by MOPI member companies, mainly through generics and biosimilars
This trend highlights the role of locally manufactured generics in supporting affordability and broad patient access, while contributing to the sustainability of healthcare expenditure.
Our Role at MOPI
MOPI works with Government ministries, regulators, and stakeholders to promote the role of generics and biosimilars within Malaysia’s healthcare system, in line with national health objectives. This includes supporting constructive policy dialogue, regulatory clarity, and industry capability development to ensure that patients have continued access to quality, safe, and affordable medicines.
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