The Bengaluru-based Biocon has been awarded MYR 300 million (approximately Rs 460 crore) contract by Malaysia’s Ministry of Health (MoH) for supplying recombinant human insulin (rh-Insulin) formulations. As per the contract, to be serviced over a period of three years, Biocon will manufacture rh-insulin formulations at its large scale biopharmaceutical facility in Johor, Malaysia.
The company’s rh-insulin is Malaysia’s first locally manufactured biosimilar biologic product approved by the National Pharmaceutical Regulatory Authority (NPRA), Malaysia, for commercial sales in the country. This marks the commercialisation milestone of Biocon’s first overseas facility in Malaysia.
The company’s subsidiary, Biocon SDN BHD, will supplying rh-insulin cartridges and re-usable insulin pens under the Malaysian government’s Off-Take Agreement (OTA) initiative, which seeks to encourage local manufacturing of new pharmaceutical products thus lowering the country’s reliance on imports and also enhancing the exports potential. The contract is extendable for additional two years subject to approval by the Government of Malaysia.
Biocon will distribute insulins and insulin delivery devices through CCM Pharmaceuticals, a leading local pharmaceutical player which has an extensive supply chain network to service primary healthcare clinics and hospitals across Malaysia.
Kiran Mazumdar-Shaw, chairperson & managing director, Biocon, said, “We are pleased to support the Ministry of Health of Malaysia in providing high quality, affordable, rh-insulin for people with diabetes in Malaysia. It is a matter of pride that this is a Made in Malaysia insulin product manufactured by Biocon Sdn Bhd at the BioXcell Biotech Park in Nusajaya,
Johor. We expect our Malaysian facility to cater to the growing needs for affordable insulins across the globe.”
Rapid urbanisation, changing lifestyles and sub-optimal dietary habits are leading to a high incidence of diabetes in Malaysia, with over 3.3 million people currently diagnosed with diabetes. The Malaysian government spends nearly about $ 566 per year on every diabetic and with the number of people with diabetes projected to cross over 4.5 million by 2020, it will impact the government’s healthcare expenditure significantly. Locally manufactured affordable rh-insulin has the potential to reduce the diabetes treatment cost burden and increase the access to insulin therapy for diabetes patients in Malaysia.
Rh-insulin is the first product from Biocon’s Malaysian facility, set up with an investment of MYR 1.1 billion. Biocon, one the leading producers of insulins in Asia, has been the first company from India to introduce biosimilar insulin glargine in Japan in 2016. It has received regulatory approvals for rh-insulin in over 60 emerging markets and is providing the product in many of these markets through its local partners. The company had earlier announced the regulatory filing with the European Medicines Agency (EMA) for biosimilar insulin glargine validated at the Malaysian facility.
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