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Biosimilar Insulins Can Increase Affordability

India is home to 74 million people with diabetes, making it the country with the world’s second-largest adult diabetes population. Every sixth person with diabetes in the world is an Indian, the Indian Council of Medical Research (ICMR) recently said, adding that the number of people with diabetes in the country have increased 150 per cent in the past three decades. 

Physiologically, diabetes is symptomatic of unmanaged blood sugar due to sub-optimal production of insulin, a hormone that regulates glucose in the body.   

Diabetes management includes a combination of timely screening, healthy lifestyle, diet, weight loss and timely medications. Insulin therapy is an essential component for controlling sugar levels in individuals suffering from Type 1 diabetes. The progressive nature of the disease warrants the use of insulin for many of Type 2 diabetes patients. 

Since diabetes is a chronic condition causing severe complications, insulin treatment – and the costs involved – is a lifelong undertaking. In such a scenario, the affordability of the treatment becomes a critical factor in disease control both at the individual and societal levels. 

Biosimilar insulins, which are equivalent to the innovator reference product in terms of quality, efficacy, safety and immunogenicity, hold huge potential in expanding the choice of insulins in countries like India, thus increasing both availability and affordability of this therapy. 

The Need for Insulins Affordability 

Among patients diagnosed with diabetes, only half undergo treatment in India because the high cost of managing the disease is a huge deterrent. This means the treatment for diabetes gets hugely compromised. Family priorities and financial prudence force many diabetes patients to resort to alternative therapies like herbal, yoga, and diet control, etc.  

Moreover, compliance to diabetes treatment in India is very poor. Only half of those being treated for diabetes are probably compliant to treatment schedules. Most patients initially visit a doctor and then discontinue their therapy once they see some signs of improvement. In case of women, since they prioritise the health of other family members, their level of compliance to treatment falls below this low average. 

Types of Insulins 

Recombinant human insulin (rh-insulin) and analogs of insulin with different pharmacological profiles have been approved across the globe for the treatment of diabetes. The analogs of insulin include rapid acting insulins such as Insulin Aspart and Insulin Lispro, long-acting insulins such as Insulin Glargine 100 IU etc. 

Globally, the accessibility of rh-insulin and insulin analogs by patients has been limited because of prohibitive pricing.  Hence, it is essential that affordable options of these insulins are available. In this context, regulatory agencies across the world including U.S. Food and Drug Administration, European Medicines Agency, Central Drugs Standard Control Organisation (CDSCO) etc have developed regulatory frameworks to approve biosimilar insulins.  

Need to Improve Awareness of Biosimilar Insulins 

The contribution of biosimilar insulins in diabetes management and patient care is a work in progress. Many healthcare professionals (HCPs) are not completely aware of the efficacy and safety aspects of these products. Closer engagement between pharma companies and HCPs and assurance in terms of the product quality and safety will be a critical component in gaining more acceptance of insulin biosimilars in diabetes care management. All stakeholder groups - patients, healthcare providers, payers - can benefit from medical education about biosimilars.  

On the basis of robust evidence, biosimilar Insulin Glargine was given the first-ever interchangeable label for a biosimilar by the U.S. Food and Drug Administration (FDA), i.e., pharmacies are authorised to dispense the product as a substitute to the reference product, Lantus. The remarkable outcome about the interchangeability of its biosimilar Insulin Glargine with that of the reference product was communicated to thousands of healthcare professionals across the country through a series of CMEs well as the on-ground SWITCH campaign.  

In my regular OPDs, I see a lot of patients who are dependent on insulins and many of them are unsure of being consistently reliant on it considering its higher cost and lesser options for reasonable insulins. Top pharmaceutical companies like Biocon have introduced world class Biosimilar insulins that has been approved by the US FDA with an ‘interchangeable status’. It allows a practitioner like me to prescribe a world class product at an affordable amount to my patients and help them have a better quality of life and manage their disease better. 

The education of patients and prescribers will play a crucial role in growing biosimilar adoption in India as the number of diabetes patients increase in the country.

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