Biocon Biologics  /  Malaysia  /  Biocon Biologics Malaysia

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

Biocon SDN. BHD., Malaysia, was established as Biocon Biologics’ first overseas manufacturing facility. Located within BioXcell, a biotechnology park in Iskandar Puteri, Johor, the facility has end-to-end capabilities for manufacturing a robust portfolio of human insulin and insulin analogs for global markets.

The state-of-the-art integrated insulin manufacturing facility was set up with an investment of over USD 350 million (MYR 1,543.5 million), the largest foreign investment in biotechnology in Malaysia till date.

The 562,000 sq. ft. commercial scale, globally compliant facility has capabilities for manufacturing drug substance, drug product and devices for human insulin and insulin analogs.

The facility is the first and only biopharmaceutical sterile injectables facility in Malaysia to receive approvals from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

With over USD 350 Million investment, about 800 strong workforce, it is the single largest biotech facility in Malaysia. The prestigious Malaysia Book of Records, the official, record-keeping body in Malaysia, had recognized Biocon Sdn. Bhd., Malaysia as the first and largest integrated insulin manufacturer in Malaysia in 2022.

World-Class Facility

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.

Quality Excellence

In addition to the U.S. FDA, EMA, the manufacturing facility in Johor is approved by NPRA, Malaysia, 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 products manufactured at the facility.

Mission to Enable Universal Access to Insulins

As one of the leading, global manufacturers of insulins, Biocon Biologics is benefiting millions of patients in Malaysia and other countries through its scientifically validated, high-quality human insulin and analog products manufactured at the facility. Biocon Biologics has cumulatively supplied 7.3 bn doses of insulins (rh-Insulin + Insulin Glargine) globally till FY24.

The Company 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.

Capacity Expansion

In anticipation of the increase in demand for insulins, Biocon Biologics had started expanding capacity in Malaysia in 2023 with an additional investment of USD 250 million (MYR 1,102.5 million). The Phase 2 investments will double the Company’s capacity, thus enabling it to cater to the additional demands for human insulin and Insulin Glargine.

Our Stories

Through Our Stories, Biocon Biologics showcases the attributes that make it a unique biosimilars company. These stories talk about BBL’s spirit of resilience and unwavering purpose in transforming healthcare, transforming lives. They narrate how the company has always gone the extra mile to support patients, caregivers, healthcare, professionals, partners, and customers.

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Reducing Malaysia’s Dependency on Imports

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. Biocon Biologics has provided the MoH over 87 million insulin cartridges and has served nearly 300,000 people with diabetes in Malaysia since 2016.

Following Biocon Biologics’ entry into Malaysia, prices of human insulin have dropped by over 40% and insulinization has improved by 30%, according to a market study. Beyond insulins, Biocon Biologics also serves the needs of cancer patients in Malaysia through its Trastuzumab and Bevacizumab biosimilars.

Commitment to Sustainability

In Malaysia, Biocon Biologics integrates responsible and sustainable business practices in its day-to-day operations to create a better tomorrow for the planet and its people. Through efficient management of energy, waste, water, and biodiversity, the Company aims to make sustainable utilization of resources and minimize environmental impact. Some key sustainability initiatives in Malaysia include:

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Rooftop solar panels: Solar panels installed in the Malaysia facility have the capacity to generate more than 1,000 kWp of renewable energy. The panels have the potential to offset ~1.6 tCO2e emissions every month.

Solvent recovery processes: Solvent recovery processes deployed at the Malaysia facility allow efficient reuse of solvents, significantly reducing the need for new batches and lowering carbon footprint.

Scaleban technology: Successful implementation of Scaleban technology supports the Company’s water conservation goals, significantly reducing freshwater intake and advancing Zero Liquid Discharge objectives.

Diverse and Dedicated Workforce

Biocon Biologics has around 800 employees in Malaysia, involved in various aspects of the insulin production process, from research and development to manufacturing and quality control. The facility is known for its high standards and innovative approaches, which are driven by a dedicated team of professionals committed to improving patient outcomes.

The Malaysia team comprises people from diverse nationalities and cultural backgrounds, and includes experts in biotechnology, engineering, quality assurance, and regulatory affairs. The Company emphasizes a culture of innovation and continuous improvement, providing its employees with opportunities for professional growth and development.

Biocon Biologics Malaysia fosters a collaborative, inclusive, and innovation-driven work culture, offering mentorship programs, training initiatives, and prioritizing diversity in hiring practices.

Leading the Way in Environmental Stewardship

Biocon Biologics actively encourages its employees in Malaysia to participate in various volunteering activities through the Biocon Malaysia Volunteer Community (BMVC).

The Malaysia team has planted saplings, cleaned beaches, restored mangroves and fed the homeless, bringing hope and healing to the planet and its people.

Biocon Malaysia volunteers collaborated with the Kechara Soup Kitchen (KSK), a non-profit organization, to distribute food to the homeless and collect surplus food from supermarkets for redistribution, effectively reducing food wastage.

They also participated in healthcare initiatives with the Johor Outreach & Community Centre, providing mobile clinic services to refugees and underserved populations.

The Biocon Biologics Malaysia team is making continuous investment in responsible and sustainable business practices that help create a healthier planet. The employees are deeply committed to biodiversity and land conservation.

As part of the Malaysia Biologics Woodlands Project, employees planted more than a thousand trees in collaboration with local authorities. They also joined the Desaru Bebas Plastic initiative, a collaborative effort supported by the Pengerang Municipal Council, to remove over 230 kilograms of waste from the Tanjung Balau waterway shorelines.

The team’s efforts and their impact were recognized at the 9th edition of the Sustainability & CSR Malaysia Awards 2024, where they won the prestigious Company of the Year (Biotechnology Manufacturing) award.

Our Global Scale Capabilities

Biocon Biologics offers one of the industry’s widest and deepest biosimilars portfolios, including monoclonal antibodies, insulin and insulin analogs and conjugated recombinant proteins. We have built cutting-edge R&D capabilities and created global-scale manufacturing capacities for insulins and antibodies that meet the most stringent of regulatory norms. Our commercial footprint for biosimilars stretches to over 100 countries.

Biocon Sdn. Bhd.

No. 1, Jalan Bioteknologi 1, Kawasan Perindustrian SiLC, 79200 Iskandar Puteri, Johor, Malaysia

For more details or enquiries:

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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