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Biocon Biologics  /  About Us  /  Biocon Biologics Malaysia

BIOCON SDN BHD, MALAYSIA – MAKING A DIFFERENCE IN MALAYSIA AND BEYOND

Biocon Biologics has created a Center of Excellence (CoE) for insulins in Malaysia with end-to-end capabilities to manufacture a broad portfolio of regular, basal and rapid insulins. The state-of-the-art insulins facility in Johor is the first and only biopharmaceutical sterile injectables facility in Malaysia to receive U.S. Food and Drug Administration (FDA) and European Medicines Agency approvals. More recently, Biocon’s biosimilar insulin Glargine made at Malaysia received a historic the U.S. FDA approval as the ‘first interchangeable biosimilar’.

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Through Biocon Sdn Bhd, Biocon Biologics has set up Asia’s largest integrated insulin manufacturing and R&D facility in Malaysia at an investment of over USD 350 million. This is the largest foreign investment in biotechnology in Malaysia, reflecting Biocon Biologics’ commitment to put affordable life-changing insulins within the reach of patients across the world. 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.

As the only insulin manufacturer in Malaysia, Biocon Sdn Bhd has been able to ensure insulin self-sufficiency in Malaysia and improve insulin access while providing savings to its partner, Ministry of Health (MoH), Malaysia. Since Biocon’s entry into Malaysia in 2011, the prices of human insulin have dropped by over 40% and insulinization has also improved by 30%.

Biocon Biologics is addressing the global need for high quality insulins at affordable prices through our Center of Excellence (CoE) for insulins in Malaysia.

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Through the insulins manufactured at this facility, Biocon Sdn Bhd is also making a difference to the lives of millions of people with diabetes worldwide by providing them access to affordable life-saving insulin therapy.

The scientifically validated, high quality human insulin and analog products manufactured at the facility in Johor, Malaysia, are benefiting patients in many developed markets like the U.S., EU, Australia, as well as many emerging market countries in the Middle East and Latin America.

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.

Encouraged by the demand for its current insulin portfolio globally and the pipeline before it, Biocon Biologics has initiated investments to expand our insulins manufacturing facility in Malaysia.

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.

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