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Transforming the Diabetes Landscape through Biosimilar Insulins

Globally, biologics like insulins and monoclonal antibodies have emerged as a class of highly effective transformational life-saving drugs targeted at chronic diseases like diabetes and cancer.

Today, there are a range of cutting-edge biologics to manage or cure a variety of conditions. But more often than not, the high cost of these therapies push them out of the reach of many patients, especially those in low- and middle- income countries where common treatment regimens can cost several months’ wages making the treatment for chronic diseases simply unaffordable.

In developed countries, too, high prices of biologic drugs have created a wide discrepancy in the availability and affordability of many essential medicines. Often life-saving biologics drugs are accessible to only an affluent section of the population.

As a result, millions of patients suffering from life-threatening or chronic diseases across the globe have to submit themselves to older generation drugs as they don’t have the financial wherewithal to afford these biological medicines.

The introduction of biosimilars, which offer comparable levels of safety and efficacy as original biologics, has transformed thousands of lives in many parts of the world. Competition among biosimilar players has translated into benefits for patients, who are able to access advanced therapies at affordable prices.

Biosimilars: An Affordable Alternative

Nearly a century after the discovery of insulin, millions of people with diabetes are denied access to this life-saving therapy due to its prohibitive costs. Insulin-dependent patients are not just finding it difficult to access insulin in poorer, developing countries, even those in developed markets like U.S. are being forced to ration insulin often with fatal consequences.

At Biocon Biologics, we are guided by the conviction that a life-saving product like insulin cannot be priced out of the reach of those who need it on an everyday basis, whether in an advanced economy like the United States, low and middle-income countries in Africa, or anywhere else on the planet.

As a credible, global insulins player, we have made significant investments in developing and manufacturing a leading portfolio of recombinant human insulin (rh-insulin) and insulin analogs such as Glargine. Our rh-Insulin and Glargine products are already benefiting people with diabetes in many emerging and developed markets through improved access and affordability. Our rapid acting insulin analog, Aspart, is currently under active review in both the U.S. and EU.

A Legacy of Improving Insulin Access

As a country based out of India, we were aware of the huge unmet need that patients in India and the developing world suffered on account of lack of access and affordability of insulin.

Nearly two decades ago, we chose to develop a recombinant human insulin (rh-Insulin) using our proprietary fermentation technology to make the therapy available to people with diabetes who were struggling to afford the product in India.

Our rh-Insulin underwent extensive clinical trials in India before we obtained regulatory approval to launch the product as Insugen® in 2004. We introduced Insugen® in India at a disruptive price point, compelling innovator companies to drop prices of their brands. Over the last decade and a half, we have cumulatively supplied over 2 billion doses of rh-insulin to patients globally.

Biocon subsequently moved on to developing insulin analogs, which allowed superior metabolic control and ensured a better quality of life and improved treatment satisfaction. Having made a difference to people with diabetes in India with our rh-Insulin, we took up the challenge of developing biosimilar Insulin Glargine.

Our efforts culminated in the approval and subsequent launch of Insulin Glargine in India under the brand name Basalog® in 2009, providing diabetes patients with an advanced, affordable insulin therapy.

To take biosimilar Insulin Glargine to people with diabetes worldwide, Biocon initiated a global development program in 2010. The insulins program got a fillip in 2013, after Mylan, a global leader in generic medicines, came forward to partner us for co-developing a basket of insulin analogs, including Insulin Glargine, Insulin Aspart and Insulin Lispro. It was an extension of an earlier agreement to jointly develop monoclonal antibodies and other biologics with Mylan for global markets.

We now have the full spectrum of insulins (regular, basal and rapid) and the global scale necessary to make a difference to diabetes patients globally.

Our proprietary fermentation technology for manufacturing affordable insulins have helped expand the market, rationalize prices and improve patient compliance.

Having expanded access to this therapy globally, our aspiration is to make this lifesaving therapy available to ‘one in five’ insulin dependent patients across the world.

Our rh-Insulin is making a difference in the lives of people with diabetes in nearly 40 countries and our Insulin Glargine is benefiting patients in ~30 countries, including developed markets like U.S., Australia, EU and Japan.

Unlocking Universal Access to Insulins

Even as we near the 100th anniversary of insulin being first used to treat a patient with diabetes, lack of equitable access to affordable insulin remains a key impediment to successful treatment for diabetes, leading to co-morbid complications and premature deaths.

There is a huge unmet need for insulins in low and middle-income countries (LMICs), which are home to nearly 80% of the global diabetes population.

Diabetes and its associated co-morbidities pose perhaps the biggest financial challenge to any proposed universal healthcare model. In fact, it creates an economic future mortgaged to paying for multiple organ disease and loss of productivity.

In September 2019, Biocon Biologics came forward to enable universal access to rh-Insulin through its ‘Mission 10 cents’ program. The announcement was made at a UNAIDS Health Innovation Exchange event held on the side-lines of the 74th session of the UN General Assembly in New York.

Under this program, Biocon Biologics is offering rh-insulin at less than 10 U.S. cents per day, assuming a daily dosage of 40 IU, in LMICs for vials sourced by the government directly from the Company. This is almost a third of the blended median patient prices for rh-insulin in LMICs.

This initiative is a part of our larger commitment to support LMICs build a sustainable healthcare ecosystem that enables equitable access to insulins.

As part of this commitment, Biocon Biologics has recently partnered with the municipal governments in the Philippines to supply its rh-insulin at less than 10 U.S. cents a day besides developing a long-term, integrated diabetes management program that enables affordable access for patients. We have recently signed a Memorandum of Understanding (MoU) with the Christian Social Services Commission (CSSC), a faith-based organization active in Africa, to take forward our ‘Mission 10 cents’ to Tanzania.

Pairing Insulins with Digital Therapeutics

At Biocon Biologics, innovation goes beyond a specific mode of action or molecular target. We are looking to come up with innovative ways to improve treatment outcomes for patients globally, such as by pairing our insulin products with digital therapeutics.

Earlier in 2020, Biocon Biologics entered into a global collaboration with Voluntis to develop and distribute innovative digital therapeutics supporting people with diabetes on biologics therapy. This collaboration will enable us to pair a U.S. FDA-cleared, prescription-only digital therapeutic, Insulia, with Biocon Biologics’ range of insulin products.

We plan to offer this easy-to-use digital therapeutic and affordable insulin combination to insulin-dependent patients in various markets across the world.

At Biocon Biologics out goal is to co-create with our partners a patient ecosystem that goes beyond the product to transform the lives of millions of diabetes patients globally.

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