@Halal September/October 2026 | Page 23

23
September-October. 2026 | @ Halal
HALAL PHARMA
23

Biosimilars broaden access

GLOBAL AMBITIONS: Duopharma Biotech’ s operations reflect its expanding focus on pharmaceutical innovation, speciality therapies and wider access to medicines in international markets.
Looking ahead, Wan Amir-Jeffery said product development will continue to reflect the shift toward speciality care.
“ There is a clear shift toward speciality care areas such as diabetes, cancer, and renal treatments, where we are expanding our therapeutic franchises and biosimilars portfolio through international collaborations.
“ At the same time, we are investing in biotechnology platforms and innovative delivery systems, ensuring that new medicines meet both global regulatory standards and halal certification requirements.”
PARTNERSHIPS OPEN MARKETS Duopharma Biotech’ s international footprint extends to 31 countries, with Southeast Asia identified as the immediate growth engine, particularly the Philippines, Singapore and Indonesia, where the company already has operations.
The company also sees opportunities in Muslim-majority markets across Asia, the Middle East and Africa, where demand for halal-certified pharmaceuticals is expanding.
“ Strategic partnerships are absolutely critical to Duopharma Biotech’ s growth model,” Wan Amir-Jeffery said.
“ They allow us to accelerate technology transfer, bringing advanced therapies and biosimilars into Malaysia and the wider region far more quickly than if we were to develop them alone.
“ Equally important, partnerships open doors to market access. By working with trusted global and regional partners, we gain entry into new markets, build distribution strength, and enhance cost effectiveness of medicines.”
BUILDING THE NEXT PHASE Wan Amir-Jeffery said speciality care, preventive healthcare, digital health and
" Our focus has broadened beyond generics into speciality therapy areas such as metabolic, oncology and nephrology, alongside a growing biosimilars portfolio developed through international collaborations."
Wan Amir-Jeffery Wan Abdul Majid
pharmacoeconomics are expected to continue influencing pharmaceutical manufacturing and healthcare delivery.
“ Several emerging trends are reshaping the future of pharmaceutical manufacturing and healthcare delivery, and Duopharma Biotech is positioning itself to lead in these areas.
“ There is a clear shift toward speciality care and biosimilars, particularly in diabetes, cancer, and renal treatments where innovation and accessibility are critical.”
At the same time, he said the company expects preventative healthcare supplements and food supplements to gain greater prominence as healthcare increasingly encompasses wellness beyond treatment.
The company is incorporating digital health and pharmacoeconomics into its
approach to healthcare delivery. Wan Amir-Jeffery pointed to the iBreastExam study, which is intended to enhance early detection, screening and cost-effective healthcare solutions.
He also emphasised that responsible environmental management, ethical governance and halal assurance are increasingly important to trust and global market access.
Over the next five years, Duopharma Biotech plans to accelerate innovation and R & D, deepen its presence in Southeast Asia and emerging markets, and leverage international technology-transfer partnerships to expand its pipeline.
Its sustainability priorities include working towards carbon neutrality by 2030 and net zero carbon emissions by 2050, alongside stronger waste, water and energy management.
The direction reflects an effort to combine scientific development, halal assurance and wider access as Malaysia seeks to build on its established credentials and expand its role in global halal pharmaceutical innovation.
INDUSTRY MILESTONE: Duopharma Biotech representatives receive JAKIM halal certification, marking a milestone in the development of halal-certified biosimilars.
Biosimilars are becoming a central part of Duopharma Biotech Berhad’ s( Duopharma Biotech) long-term strategy as the company expands access to cost effective biological medicines in high-value treatment areas.
“ Biosimilars are a highly significant pillar of Duopharma Biotech’ s long-term growth strategy,” said Duopharma Biotech Group Chief Executive Officer Wan Amir-Jeffery Wan Abdul Majid.
“ They represent a critical pathway to improving access to affordable biologic medicines, particularly in highvalue therapeutic areas such as metabolic, oncology and nephrology.”
BUILDING LOCAL CAPABILITY“ Through international collaborations, we have already introduced biosimilars like the first erythropoiesisstimulating agent( ESA) certified halal by Department of Islamic Development Malaysia( JAKIM). and expanded our insulin portfolio, ensuring that patients benefit from advanced treatments at lower cost,” he said.
The biosimilar product was developed for anaemia in patients with chronic kidney disease, including adult and paediatric haemodialysis patients. It became Malaysia’ s first halal-certified biosimilar Epoetin Alfa.
In 2014, Duopharma Biotech became the first Malaysian pharmaceutical company to embark on a Phase 3 clinical trial for an Epoetin Alfa biosimilar in collaboration with PanGen. In 2018, it installed Malaysia’ s first biologic prefilled syringe line to manufacture an Epoetin Alfa biosimilar.
The biosimilar received registration approval from the National Pharmaceutical Regulatory Agency in 2019 before obtaining halal certification in 2025.
In 2020, Duopharma Biotech and PanGen Biotech announced plans to establish Malaysia’ s first commercial biosimilar production facility.
The company’ s role has since expanded through technology-transfer and commercialisation collaborations with international partners.
NEXT-GENERATION BIOLOGICS“ Looking ahead, biosimilars will continue to anchor our innovation pipeline, complementing our halal-certified generics and speciality medicines.”
Duopharma Biotech plans to expand its biosimilar portfolio and strengthen strategic partnerships, focusing on high-value products such as erythropoietin and insulin analogues as cost-effective alternatives to complex biologic medicines.
“ The company continues to advance commercialisation and regulatory approvals for next-generation biosimilars in targeted areas like oncology, metabolic, and immunology.”
Duopharma Biotech also plans to leverage partnerships with international biotech firms to transfer manufacturing technology and facilitate local production of complex biologics.
“ The collaborative efforts are directed toward joint research and development( R & D) projects to accelerate the deployment of innovative drug delivery systems and speciality formulations,” Wan Amir-Jeffery said.
By embedding halal integrity into biosimilar development, the company aims to broaden patient choice while strengthening Malaysia’ s position in the global halal pharmaceutical market.