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a century of insulins
Biocon  /  A Century of Insulins

A Century of Insulins and Biocon Biologics

We are marking 100 years of one of the most pivotal breakthroughs of modern medical history – the discovery of insulin. On 12th December 1921, Frederick Banting and Charles Best reported the results of the discovery of insulin to the American Society of Physiology.

The discovery of insulin is a milestone in medical science as it led to a revolution in the therapy and prognosis of diabetes, which is one of the most studied diseases in the history of medicine. The first references to diabetes can be traced back to a collection of ancient Egyptian, Indian and Chinese textbooks.

When Banting discovered insulin, he refused to put his name on the patent as he felt it was unethical for a doctor to profit from a discovery that would save lives. His co-inventors, Best and James Collip, sold the insulin patent to the University of Toronto for a mere $1. They wanted to ensure that everyone who needed insulin to be able to afford it.

The Nobel Prize in Physiology or Medicine 1923 was awarded jointly to Banting and John Macleod “for the discovery of insulin.”

A century after its discovery, insulin is saving the lives of millions of people with diabetes each year.

Biocon Biologics has been on a mission to provide affordable access to high quality, life-saving insulins worldwide.

Biocon Biologics’ Insulin Journey – Milestones

2000 – Leveraged fermentation technology strengths to start insulin development program

2004 – Brought down insulin prices in India with launch of indigenously developed rh-Insulin (Insugen®)

2009 – Launched biosimilar Insulin Glargine (Basalog); offering basal insulin analog option to patients in India

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100 years of Insulin Journey - Key Milestones

1921 – Dr Frederick Banting and medical student Charles Best devised a way to extract insulin from the pancreas of a dog. Using this insulin, they succeeded in keeping another dog, grappling with debilitating diabetes alive for 70 days.

1922 – Leonard Thompson, a 14-year-old boy dying from type 1 diabetes, became the first person to receive an injection of insulin.

1923 – Eli Lilly manufactured ‘lletin’ (animal origin insulin), the first commercially available insulin in the U.S.

1955 – British biochemist Frederick Sanger fully sequenced the bovine insulin and discovered its exact composition in terms of amino acids. For this discovery, Sanger won the Nobel for Chemistry in 1958.

1975 – Fully synthetic insulin (CGP 12 831) was synthesized in the laboratories of Ciba-Geigy in Basel.

1978 – David Goeddel and his colleagues (of Genentech) successfully developed the first recombinant DNA (rDNA) human insulin by merging the insulin A- and B- chains expressed in Escherichia coli.

1980 – rDNA human insulin was first tested in a sample of 17 non diabetic volunteers, in England. The first diabetic patient treated was Sandy Atherton, 37-year-old, from Wichita, Kansas, U.S.

1980-90s – Insulin analogs, which represented a major improvement in pharmacokinetic properties compared with recombinant human insulin, were developed.

1996 – Insulin Lispro, a rapid-acting insulin analog, received approval in the U.S.

2000 – Insulin Aspart, a rapid-acting insulin analog, was approved by the U.S. FDA. In the same year, the U.S. regulator approved Insulin Glargine, a long-acting insulin analog.

Biocon Biologics’ Insulin Journey – Milestones

2000 – Leveraged fermentation technology strengths to start insulin development program

2004 – Brought down insulin prices in India with launch of indigenously developed rh-Insulin (Insugen®)

2009 – Launched biosimilar Insulin Glargine (Basalog); offering basal insulin analog option to patients in India

2011 – Introduced a reusable insulin pen, INSUPen®, marking a foray into devices.

2013 – Partnered with Mylan to co-develop biosimilar insulin analogs for global markets.

2015 – Launched a pre-filled, disposable Insulin Glargine pen (Basalog One) to strengthen insulins portfolio in India.

2016 – Biosimilar Insulin Glargine approved & launched in Japan; 1st biosimilar from a company in India to be approved in Japan.

2017 – Started commercial operations at our first overseas insulins manufacturing facility in Malaysia.

2018 – Semglee®* (biosimilar Insulin Glargine) received EC approval; Commercialized in Europe by our partner

2019 – Biocon Biologics unveiled ‘Mission 10 Cents’ program to expand insulin access by offering rh-Insulin at less than 10 US cents / day to governments in LMICs.

2020 – Semglee (biosimilar Insulin Glargine injection) received U.S. FDA approval; Commercialized in U.S. by our partner

2021 – Received world’s first interchangeable biosimilar approval from U.S. FDA for Semglee (biosimilar Insulin Glargine)

2021 – Introduced insulin initiation kits in India for rh-Insulin (Insugen®) and Glargine (Basalog®) to enable a smooth transition from oral antidiabetic drugs to insulins for people with diabetes.

Biocon Biologics’ Journey of Increasing Access to Insulins Worldwide

Biocon Biologics has been on a mission to provide affordable access to high quality, life-saving treatments such as insulin.

As a frontrunner in developing lifesaving biosimilars for treating diseases like diabetes and cancer, the company has made huge investments in R&D and manufacturing and is now leveraging its expertise and scale to reduce disparities in access to safe, high-quality insulins.

Insulins production is expensive involving extensive scientific knowhow, complex recombinant DNA led bio-processing technology and state-of-the-art manufacturing infrastructure. Despite its capital-intensive nature, Biocon Biologics has succeeded in expanding access to insulin therapy worldwide.

In the early 2000s, we leveraged our expertise in fermentation science to come up with a proprietary yeast platform based on Pichia pastoris to make recombinant human Insulin (rh-Insulin) at a time when other insulin makers were using the tried and tested Escherichia coli bacterial expression system.

The launch of our rh-insulin at a disruptive price point in 2004 triggered a series of developments. International insulins makers lowered their prices for India, and the government gained the confidence to bring rh-Insulin under price control as it finally had a domestic alternative. Our product benefited a large pool of diabetes patients, both directly as well as indirectly, in India.

With the advent of modern insulin analogs in India, we introduced long-acting Insulin Glargine in 2009, expanding the pool of available quality insulins. Over the past decade, we have gained approvals and commercialized Insulin Glargine in several global markets, including developed economies like U.S., EU, Japan and Australia.

Our rapid acting insulin analog, Insulin Aspart, has received regulatory approvals in developed markets like EU and Canada and emerging markets like Malaysia.

We now have a broad portfolio, comprising basal, mixed and rapid acting insulins, which will enable us to meet varied patient needs and make a difference globally.

We aspire to reach ‘one in five’ insulin-dependent people with diabetes worldwide through our insulins.

The Importance of Insulin

Insulin is a hormone that regulates blood sugar. Diabetes is a chronic condition that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. The body’s inability to produce sufficient levels of natural insulin can lead to diabetes – both inherited Type 1 and Type 2.

People with Type 2 diabetes don’t use insulin efficiently and don’t produce enough insulin. People with Type 1 diabetes make little or no insulin.

For people with Type 1 diabetes, insulin therapy is vital for replacing the insulin the body doesn’t. People with Type 2 diabetes need insulin therapy if other treatments haven’t been able to keep blood glucose levels within the desired range.

Untreated, high blood glucose can eventually lead to complications such as blindness, nerve damage and kidney damage.

Insulin therapy helps prevent diabetes complications by keeping a person’s blood sugar within the target range. It helps improve long term control and quality of life in patients with diabetes.

Insulin Access Not Universal

Despite its universal availability for the last century, insulin is yet to be universally accessible.

Lack of access to affordable insulin remains a key impediment to successful treatment of diabetes and results in needless complications and premature deaths, according to the World Health Organization (WHO). High blood sugar levels have been linked to 4.2 million deaths annually around the world in 2019.

Millions of people with diabetes are denied access to this life-saving therapy due to its prohibitive costs. Insulin-dependent diabetes patients are not just finding it difficult to access insulin in emerging markets, even those in developed markets like the U.S. are finding it difficult to afford insulins therapy.

Biocon Biologics believes this situation is untenable and is committed to change it.

Biocon Biologics’ Mission 10 Cents to Expand Universal Access to Insulins

In the run-up to the 100th anniversary of the discovery of insulin, we launched our ‘Mission 10 cents’ to offer recombinant human Insulin at less than 10 U.S. cents / day, or almost a third of current prices, to governments in low- and middle-income countries where millions of people cannot access insulin as it is unaffordable. We have already rolled out this program in Philippines and Tanzania. Under this program, we are engaged in diabetes awareness campaigns to promote early diagnosis and better diabetes management through our local partners.

Biocon Biologics Broad Insulin Portfolio

Semglee® received historic U.S. approval as the first interchangeable biosimilar.

What Biocon Biologics is doing to increase access and compliance to insulin therapy

Biocon used its inherent strengths in fermentation technology to come up with a differentiated technology, a proprietary yeast platform based on Pichia pastoris, to make recombinant human Insulin (rh-Insulin) at a time when other insulin makers were using the ‘tried and tested’ Escherichia coli bacterial expression system.

This proprietary technology enabled the company to produce human insulin in a cost effective manner using an efficient optimized process.

Biocon Biologics continues to be the only company in the world that is producing rh-Insulin and insulin analogs on a Pichia platform. Taking this risk has enabled Biocon to emerge as a leading insulins player globally.

Biocon Biologics has built one of India’s largest bio-manufacturing facilities for insulins in Bangalore, India. It continues to invest in expanding its manufacturing capacities to address the growing market need. Its insulin manufacturing and R&D facility in Malaysia is the largest such integrated insulins facility in Asia.

Biocon has the full spectrum of insulins (regular, basal and rapid) in its pipeline: rh-insulin, Insulin Glargine and Insulin Aspart.

At a time when the world is seeking viable, long-term solutions to improve insulin access and affordability, Biocon Biologics came forward with its ‘Mission 10 cents’. The company has offered its recombinant human Insulin (rh-Insulin) at less than 10 U.S. cents / day for direct procurement by governments in low- and middle-income countries.

To enable better patient outcomes and reduce costs to healthcare systems, Biocon Biologics has collaborated with Voluntis for Insulia, a unique digital therapeutic solution that has U.S. FDA clearance and a CE mark, to help manage the treatment of Type 2 diabetes with bioimilar Insulin Glargine.

Biocon Biologics is engaging with key stakeholders globally to advocate for policies that will accelerate insulin development programs, ultimately bringing biosimilar insulin products to the market more quickly and benefiting patients.

To contribute to a stronger global voice for diabetes patients globally, the company had entered a partnership with the International Diabetes Federation (IDF), coinciding with the start of the centenary celebrations of the discovery of insulin.

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