Biocon Biologics is deeply committed and invested to address patients’ needs for insulins in Malaysia and other parts of the world. To serve the global demand for insulins, Biocon Biologics has created a Center of Excellence (CoE) for insulins in Malaysia with end-to-end capabilities for manufacturing its robust portfolio of human insulin and insulin analogs. The state-of-the-art integrated insulin manufacturing facility in Malaysia was set up at an investment of over USD 350 million (MYR 1,543.5 million), the largest foreign investment in biotechnology in the country till date. Commercial operations at the facility commenced in 2016 when Biocon Biologics’ recombinant human insulin became the first locally manufactured biosimilar product approved for sale in Malaysia.
BIOCON SDN BHD, MALAYSIA – MAKING A DIFFERENCE IN MALAYSIA AND BEYOND
Reducing Malaysia’s Dependency on Imports
As one of the leading global manufacturers of insulins, Biocon Biologics is committed to enable access to world-class affordable insulins to patients in Malaysia. The Company has been working closely with the Ministry of Health, Malaysia (MoH) to cater to the growing needs of diabetes patients in the country and reducing the dependency on insulin imports. Since 2016, Biocon Biologics has provided the MoH over 87 million insulin cartridges and has served the needs of nearly 300,000 people with diabetes in Malaysia.
Following Biocon’s entry into Malaysia, prices of human insulin have dropped by over 40% and insulinization has also improved by 30%, according to a market study.
Capacity Expansion in Malaysia
Biocon Biologics has made considerable progress on the second phase of the Malaysia facility, having invested an additional USD 250 million (MYR 1,102.5 million) in 2023 on expansion. Once ready, it will double the company’s capacity thus enabling it to cater to the additional demands for human insulin and insulin glargine.
World Class ‘Lab to Market’ Capabilities
Biocon Biologics is a leading integrated global biosimilars company with world-class ‘lab to market’ capabilities across development, manufacturing, and marketing.
The scientifically validated, high quality human insulin and analog products manufactured at the facility are benefiting millions of patients in Malaysia and other countries.
Biocon Biologics is the world’s first company to receive interchangeability status from the U.S. Food and Drug Administration for its biosimilar Insulin Glargine in 2021. Today, it has over 13% market share for biosimilar Insulin Glargine in the U.S., serving a very large pool of patients in the country. Biocon Biologics has cumulatively supplied 7.3 bn doses of insulins (rh-Insulin + Glargine) globally till FY24.
Quality Excellence
The Company takes pride in developing world class insulin products using its proprietary technology platform. Its manufacturing facility in Johor is approved by NPRA, Malaysia as well as several international regulatory agencies like the U.S. FDA, EMA, TGA (Australia), ANVISA (Brazil), etc. The facility has state-of-the-art R&D, Quality Assurance, Quality Control labs and a very robust Quality Management System which ensures the quality of the product manufactured at the facility.
The 562,000 sq. ft. facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by the prestigious Malaysia Book of Records, the official, record-keeping body in Malaysia.
Mission to Enable Universal Access to Insulins
As one of the leading, global manufacturers of insulins, Biocon Biologics is driven by its mission to enable universal access to insulins, so that this basic therapy reaches those who need them the most. Biocon Biologics aspires to reach ‘one in five’ insulin-dependent people with diabetes globally and it is consistently working towards this mission.
Biocon Biologics has made large investments in India and Malaysia to build global scale capacity to develop world-class human insulin and insulin analogs and has succeeded in expanding access to insulin therapy by pursuing an innovation strategy that is rooted in affordability.
Biocon Sdn. Bhd.
No. 1, Jalan Bioteknologi 1, Kawasan Perindustrian SiLC, 79200 Iskandar Puteri, Johor, Malaysia
For more details or enquiries:
T +607-5600000
E queries.malaysia@bioconbiologics.com
Global Certifications
Manufactures the Drug Substance for Biocon Biologics’ range of rh-insulin and insulin analogs as well as Drug Products in vials, cartridges and devices.
The facility, built at an investment of over USD 350 million, represents the largest foreign investment in biotechnology in Malaysia.
Biosimilar Insulin Glargine, produced in Malaysia, received a historic U.S. approval as the first interchangeable biosimilar under the 351(k) regulatory pathway in 2021.
Biocon Sdn. Bhd. has entered the prestigious Malaysia Book of Records as the first and largest integrated insulin manufacturer in Malaysia.
The product registrations in various emerging markets and regulated markets for rh-insulin and insulin analogs are in progress.
