Biocon Biologics’ Insugen® Awarded a Three-Year Contract by Ministry of Health, Malaysia

Bengaluru, India and Johor, Malaysia, April 26, 2022 –

Biocon Biologics Limited (BBL), a subsidiary of Biocon Ltd., today announced that its subsidiary Biocon Sdn. Bhd. in Malaysia has been awarded a three-year contract, valued at USD 90 million* (MYR 375 million), for its recombinant human insulin brand Insugen®, by the Ministry of Health (MoH), Malaysia.

Biocon Sdn. Bhd. in Malaysia, will manufacture and supply its range of insulins to its partner Duopharma Marketing Sdn. Bhd. (DMktg), a subsidiary of Duopharma Biotech, a leading pharmaceutical & biotech company in Malaysia.

Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics.

Susheel Umesh, Chief Commercial Officer, Emerging Markets, Biocon Biologics, said: “We are pleased to renew our commitment to provide affordable access to our recombinant human insulin for people with diabetes in Malaysia through this new government contract. This will enable us to serve over 400,000 people with diabetes using recombinant human insulin, helping the government in its journey towards equitable access to diabetes care.”

Kiran Kumar Gandhirajan, Senior Vice President and Site Head, Biocon Sdn. Bhd., said: “We have been partnering with the Malaysian government since 2016 and have expanded access to life-saving insulin therapy for patients with diabetes. Since our entry to Malaysia in 2011, prices of human insulin have dropped over 20% and insulinization has also improved by 30%. As the only insulin manufacturer in Malaysia, we have been able to achieve insulin self-sufficiency and improved access while providing savings to our partner – MOH, Malaysia.”

The rh-Insulin formulations, Insugen®-R, Insugen®-N and Insugen®-30/70, are manufactured at Biocon Sdn. Bhd.’s Johor facility and have been approved by the National Pharmaceutical Regulatory Authority (NPRA), Malaysia.

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. FDA and EMA approval. More recently, Biocon’s biosimilar insulin Glargine made at Malaysia, has received a historic U.S. FDA approval as the ‘first interchangeable biosimilar’.

In September 2021, Biocon Biologics’ Basalog (biosimilar Insulin Glargine) was awarded a multi-ministry pooled tender worth USD 4.2 million* by MoH, Malaysia for a period two years, in order to address the needs of patients in Malaysia.

Through its scientifically validated, high quality human insulin and analog products manufactured at Malaysia, Biocon Biologics is providing affordable access to these life-saving therapies to patients in many developed markets like U.S., EU, Australia, as well as many emerging market countries in the Middle East and Latin America.

In Malaysia, besides addressing the needs of people with diabetes through its comprehensive rh-insulin portfolio of Insugen R, Insugen N and Insugen 30/70 cartridges and its Basalag One, Insulin Glargine prefilled pens, Biocon Biologics is also catering to the needs of cancer patients through its portfolio of oncology biosimilars, like Zuhera (Trastuzumab 440 mg) and Krabeva (Bevacizumab 100 mg and 400 mg). These products are also distributed in Malaysia by its partner Duopharma.

As a leading global insulins player, Biocon Biologics has provided over 2.75 billion doses of rh-Insulin to patients across the world. The Company is committed to expanding affordable access to high quality insulins for patients and enabling savings for the healthcare systems across the world.

*Values quoted at Ministry of Health prices (value of contract)

Diabetes in Malaysia

There are 3.9 million adults with diabetes in Malaysiaⁱ. Type-2 diabetes has been a growing public health concern in Malaysia over the past two decades. The prevalence of Type 2 diabetes has progressively increased from 8.3%ⁱⁱ in 1996 to 20%ⁱ in 2019, whereby nearly half were undiagnosed. With ~9,000ⁱⁱⁱ new patients being diagnosed with diabetes every year, the diabetes population in Malaysia is projected to grow to over 36 million^iv by 2025, accounting for a prevalence of 31.3%. About 420,000 patients are treated using recombinant human insulin in government hospitals and clinics. Diabetes is an expensive condition to treat and its impact on Malaysian society will be substantial as it is a chronic condition needing lifelong treatment. In 2010 alone, an estimated USD 600 million was spent on diabetes-related healthcare in the country, accounting for approximately 16% of the overall national healthcare budget^v.

ⁱNational Health and Morbidity Survey (NHMS) 2019

ⁱⁱNational Health and Morbidity Survey (NHMS) 2015

ⁱⁱⁱNational Diabetes Registry Report 2020

iv Time Series Population Projection in Malaysia by 2025. 2017. Available online:
http://www.data.gov.my/data/en_US/dataset/time-series-population-projection-by-ethnic-group-and-sexmalaysia-2020-2025-2030-2035-and-2040/resource/e47083dc-78a8-4ec2-872e-eb85e422c1f2

^vGlobal healthcare expenditure on diabetes for 2010 and 2030. Zhang P, Zhang X, Brown J, Vistisen D, Sicree R, Shaw J, Nichols G; Diabetes Res Clin Pract. 2010 Mar; 87(3):293-301.

Biocon Biologics in Malaysia

Biocon Biologics has set up Asia’s largest integrated insulin manufacturing facility in Malaysia. The facility in Johor, Biocon’s first overseas biopharmaceuticals manufacturing and research facility, has been built at an investment of over USD 350 million, the highest foreign investment in Malaysia’s biotechnology industry to date. This strategic investment is helping propel Malaysia’s biotechnology industry to the next level by providing the necessary industry benchmark for quality and excellence in research, manufacturing and commercialization. Biocon Sdn. Bhd. has till date created jobs for over 750 Malaysian families and is nurturing, developing and creating a sustainable biotech ecosystem in addition to contributing towards the economy through exports. In July 2021, Biocon Biologics’ Insulin Glargine manufactured at Johor, Malaysia received approval from the U.S. FDA as the world’s first interchangeable  biosimilar. With the launch of the interchangeable insulin product, Biocon Biologics intends to expand access to this affordable innovation to  people with diabetes across the globe. The presence of Biocon Biologics’ insulins manufacturing facility in Malaysia has positioned Malaysia amongst  the 20 countries globally  to have local insulin manufacturing capacity.

About Biocon Biologics Limited

Biocon Biologics Ltd., a subsidiary of Biocon Ltd., is a unique, fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower costs of biologics therapies while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology and other non-communicable diseases. Seven molecules from Biocon Biologics’ portfolio have been commercialized in key emerging markets and developed markets like U.S., EU, Australia, Canada, Japan. It has many firsts to its credit including the most recent U.S. FDA approval of the world’s first interchangeable biosimilar, awarded to its Insulin Glargine, which has been commercialized in the U.S. in 2021. Biocon Biologics has signed a strategic alliance with Serum Institute Life Sciences (subject to certain closing conditions) to address the inequitable access to life saving vaccines and biologics globally. With a team of ~5,000 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients’ worldwide. Website: www.bioconbiologics.com; Follow us on Twitter: @BioconBiologics for company updates.