KUALA LUMPUR, Nov 6 — The Malaysian Organisation of Pharmaceutical Industries (MOPI) has endorsed the government’s mandate for the National Heart Institute (IJN) to switch from innovator drugs to generics and biosimilars.
MOPI – which represents 51 local pharmaceutical manufacturers of generics and biosimilars in the country – cited “reliable” reports that the Ministry of Health (MOH) would make cost savings of RM130 million if generics were used as alternatives to the top 10 prescribed medicines at IJN.
“The move by the National Heart Institute (IJN) towards using generics and biosimilars is to the right direction to ensure sustainability of this important Institute,” said MOPI executive director Billy Urudra in a statement today.
“This will help IJN reduce their losses and require less financial support from the government.”
Using innovator drugs is not a “loss” for IJN because it is the Ministry of Health (MOH), not IJN, that pays for the care of government patients that comprise about 85 per cent of the top cardiac centre’s patient load.
On the contrary, CodeBlue has reported that IJN potentially faces a loss of revenue of at least RM100 million, based on the RM130 million cost savings for the MOH from just the 10 most used drugs in IJN, all originators, if patients were to be treated in government facilities.
MOPI’s three-page statement today was issued in response to a four-sentence statement by the Pharmaceutical Association of Malaysia (PhAMA) that mainly represents pharmaceutical multinational companies in the country.
PhAMA said substituting innovator medicines with generics for public patients would not solve IJN’s cost management problems, telling the government that this could “backfire” instead with a higher cost and burden of disease if patients deteriorate.
“We believe this claim is baseless, non-factual, and misleading,” MOPI said in response.
“Globally, generics and biosimilars have long played a pivotal role in providing quality-assured and affordable access to medicines not only for low-income countries, but also developed countries.”
Citing data from the International Generic and Biosimilar Association (IBGA), MOPI pointed out that by volume, generics have a market share of 91 per cent in the United States, 77.5 per cent in Canada, and 70 per cent in European Union (EU) countries.
“This demonstrates how the generic and biosimilar industry has significantly expanded the reach and access of therapies globally.”
Citing an IQVIA report, MOPI noted that nearly 75 per cent of prescription medicines consumed in Malaysia in 2023 were generics and biosimilars.
“By increasing accessibility, generics and biosimilars help improve treatment adherence and reduce the financial burden on both patients and the health care system as a whole. This, in turn, contributes to better health outcomes and a more sustainable health care system.”
MOPI stressed that generics and biosimilars undergo stringent regulatory approval processes by the National Pharmaceutical Regulatory Agency (NPRA) to ensure safety, efficacy, and quality.
“Generics and biosimilars are not ‘cheap alternatives’ – they are therapeutically equivalent to their originator counterparts,” said Billy.
“They are manufactured according to the same high standards and provide patients with the same clinical benefits. The safety profile of generics and biosimilars have been well-documented globally, and they have been used to treat billions of patients without compromising outcomes.”
Billy added that due to the significantly lower cost of drugs, by as much as 50 per cent to 80 per cent, generics and biosimilars inadvertently increase accessibility to quality-assured and affordable medicines.
“This has been one of the key enablers for lowering the disease burden in many countries, while reducing the overall financial strain on health care systems,” MOPI said.
“This is particularly crucial in the context of chronic diseases, where long-term medication use is necessary. Generics also free up health care resources, enabling investment in other critical areas, such as disease prevention, infrastructure, and innovative treatments.”
Biosimilars – a class of biologic medicines that are “highly similar” to reference biologic drugs – have the potential to reduce health care costs for expensive biologic treatments for cancer, autoimmune diseases, and diabetes, according to MOPI.
“The rising cost of healthcare is a global challenge, and Malaysia is no exception. Without generics, health care providers would face insurmountable pressures to provide care, particularly in resource-constrained settings like public hospitals,” said Billy.
“By offering more affordable medicines, generics and biosimilars ensure that Malaysia’s health care system remains financially sustainable, especially in the face of an ageing population and increasing prevalence of chronic diseases. This is why the Ministry of Health has a generic-first policy.”
IJN is not a government hospital under the MOH; it is owned by the Minister of Finance Incorporated (MOF Inc.) and operates as a private hospital under the Private Healthcare Facilities and Services Act (PHFSA) 1998.
