Tag: insulin

‘Once-a-week’ insulin likely to be launched in India by 2025 — how will it benefit diabetic patients

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Danish drugmaker Novo Nordisk plans to launch “once-in-a-week insulin” by the second quarter of 2025 in India, said John C Dawber, the company’s managing director.  Vikrant Shrotriya, corporate vice-president and managing director of Novo Nordisk India, said the once-a-week insulin product is likely to be rolled out by the second quarter of 2025 if everything goes as per plan.

Dawber told News 18 the pharma company expects positive results from the trial of the medicine and that the biggest centres of the trials are in India. This will be a major breakthrough for over 7.7 crore diabetics in India of which 50 lakh patients are dependent on insulin, News 18 reported on Friday.

“There is generally a gap of nine months to one year between the launch of the product in the global or the US market and in India, the time which is taken by India’s regulatory procedures. Otherwise, India is a very important part of our global plans,” Shrotiya was quoted as saying.

Dawber told the Financial Express that India’s diabetes market has a lot of untapped opportunities.

In the next financial year, the company is unlikely to bring something to the India market. However, in 2025-26 potentially the longer acting insulin is likely to be launched in the country.

How will once-a-week insulin help diabetic patients?

India, with a population of 1.4 billion (140 crore), has nearly 8 crore people living with diabetes, out of which 50 lakh patients are insulin dependent.

Currently, patients who are prescribed insulin are required to take daily self-injections to regulate their blood sugar. This regimen can be cumbersome, inconvenient, and difficult to remember, becoming a barrier to effective insulin management and could lead to suboptimal diabetes treatment.

Since Type-2 diabetes can cause serious conditions such as heart and kidney disease and blindness, it is important to manage it efficiently.

Also, mistakes in administration of daily insulin can lead to serious complications, including high or low blood sugar and diabetic ketoacidosis, which can be fatal.

Therefore, the potential of a weekly injectable has been described as a “game-changer,” particularly for people who need daily injections or multiple injections throughout the day.

One of the biggest advantages of having once-a-week insulin is the convenience which could make a huge difference for patients who will have to take only one injection, instead of seven.

The weekly option can also make it easier to manage the care of patients with diabetes.

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USFDA allows automatic ‘generic’ swap for brand-name insulin

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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US regulators took action Wednesday that will make it easier to get a cheaper, near-copy of a brand-name insulin at the drugstore.

Doctors now have to specifically prescribe whats called a biosimilar or OK substituting it for a more expensive brand-name insulin.

Wednesdays move by the Food and Drug Administration will allow pharmacists to automatically substitute the cheaper version, just as they do with generic pills for other kinds of drugs.

Its the FDAs first approval of an interchangeable biosimilar, a near-copy of an injected biologic medicine thats manufactured inside living cells. It could save diabetics and health plans millions of dollars annually and encourage other drugmakers to create more biosimilar medicines. Health data firm IQVIA projects U.S. savings from increasing use of biosimilars from 2020 through 2024 will top $100 billion.

The FDA agreed that Viatris Inc.s Semglee was interchangeable with widely used Lantus, a fast-acting insulin.

Approval of a second such interchangeable biosimilar of a long-acting insulin appears imminent from the same developers, Pittsburgh-based generic giant Viatris and its partner, Indias Biocon.

Mylan N.V., one of two companies that merged to create Viatris last December, launched Semglee in the U.S. last summer.

Red tape, lengthy patents and pushback from brand-name drugmakers have limited U.S. sales of biosimilars to far below levels in Europe.

These products are highly similar but much more affordable, said Sean McGowan, head of biosimilars at AmerisourceBergen, a top drug wholesaler.

Only 20 of 29 FDA-approved biosimilars for cancer and immune disorders like rheumatoid arthritis are sold in the U.S. so far, he said.

Depending on the pharmacy, Semglee injector pens cost about $150 to $190 without insurance for a typical months supply, compared to $340 to $520 for the same supply of brand-name Lantus.

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100 years of Insulin discovery: The ground-breaking innovation in diabetes care

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Insulin discovery by Sir Frederick G Banting, Charles H Best and JJR Macleod in 1921 is one of the greatest medical discoveries ever. Even today, Insulin remains one of the most effective treatments for people with Type 1 diabetes. As we celebrate the 100 years of Insulin discovery, we cannot thank enough the ground-breaking innovations in insulin for diabetes care that have saved countless lives.

We are blessed today to have improved medicines than ever, yet the number of people living with diabetes continues to rise at an alarming rate, throwing a significant burden on patients, families, and the country. According to the Diabetes Atlas 2019 published by the International Diabetes Federation, the number of people with diabetes in India is currently around 77 million and is expected to rise to about 134 million by 2045. The rising prevalence of diabetes is mainly driven by a mix of factors such as rapid urbanisation, sedentary lifestyles, unhealthy diets, tobacco use, and increasing life expectancy.

While each type of diabetes has its exclusive characteristics, the distinctive feature of diabetes is either the absence of insulin (Type 1 diabetes) or the insufficient production of insulin, often tied with the body being unable to entirely respond to insulin (Type 2 diabetes). Before the discovery of insulin, the only available treatment for diabetes was a diet that restricted caloric intake so strictly that people were subjected to starvation to control their diabetes. While this did help many to extend their lives as they waited for a cure, it also meant that many people with type 1 diabetes died because of malnutrition rather than diabetes.

In 1922, the first person with diabetes to be treated with insulin was injected with insulin taken out from the pancreases of cattle. Since then, the therapeutic options available today have come a long way. Although revolutionary in the 1920s, animal-derived insulin came with a lot of risks, which included the possibility of an allergic reaction. After the discovery of insulin, the average life expectancy of a diabetes person improved drastically.

By 1945, a child diagnosed with type 1 diabetes could expect to live more than 30 years longer than a 10-year-old child diagnosed with type 1 diabetes before the discovery of insulin. This was a significant gain! Human insulin, which became commercially available in 1982, demonstrated significant advantages over animal-derived insulin.  It did not rely on a supply of animal pancreases, production was scalable, and it was identical to the insulin produced by the human body. The first insulin pen created a revolution in diabetes care and paved the way for streamlining administration and diabetes management.

In recent years, significant advances have been made in insulin therapy. The latest new generation long-acting insulins are capable of releasing medication into the bloodstream slowly over time rather than all at once. This steady release brings insulin therapy one step closer to mimicking the complex insulin action of the body, making it easier for people with diabetes to reduce the risk of low blood glucose (hypoglycemia), without compromising control over blood glucose levels.

A new generation of ultra-fast-acting insulins has also provided freedom from planning insulin injections around mealtimes. These fast-acting insulins allow people with type 1 diabetes or advanced type 2 diabetes to give themselves an injection just before eating or even after starting a meal, relieving them from the burden of planning what to eat and how much insulin to take before each meal. Each generation of insulin has sought to introduce new freedoms and flexibilities for people with diabetes.

The COVID-19 pandemic has also made people with diabetes more vulnerable to developing worse outcomes from infection, globally. However, people with well-managed diabetes have a lower risk of worse outcomes from the COVID-19. Therefore, more advancements are necessary to ensure a full and healthy life for people living with diabetes. Sustained innovation is the need of the hour to address the challenges that diabetes has on individuals and society.

According to a report by Diabetes Technology & Therapeutics, the total number of insulin-requiring patients today is expected to be around 150–200 million (this is an underestimate). The Overall insulin use would increase from 516.1 million 1000IU vials (95 percent CI: 409.0, 658.6 million) to 633.7 million per year (95 percent CI: 500.5, 806.7 million) between 2018 and 2030.

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How to deal with insulin management: Experts explain

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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On the occasion of Insulin Appreciation Day, CNBC-TV18’s Archana Shukla caught up with Dr Ambrish Mithal, chairman and head of endocrinology and diabetes department at Max Healthcare, Dr V Mohan, chairman at Dr Mohan’s Diabetes Specialities Centre and President of Madras Diabetes Research Foundation Centre at Chennai and former Indian cricketer and brand ambassador for Novo Nordisk India, Anil Kumble to discuss how to deal with insulin management and how important it is to break barriers with insulin.

Watch this video for details

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Getting ‘voluntary action indicated’ status for Malaysian unit a key development, says Biocon’s Kiran Mazumdar Shaw

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The USFDA has issued Establishment Inspection Report (EIR)  with ‘voluntary action indicated’ status to Biocon’s Malaysian unit in terms of production of Glargine.

Sharing further details CMD of the company Kiran Mazumdar Shaw said, “This is an important EIR that we have received and it is a good because it makes us feel confident that we will get the approval sooner than later.”

In terms of the timeline, she said, “We have always said that it will be in the first half of this year. So, that is what we stick by.”

With this entire COVID-19 crisis one does not know when the US markets will open for business. So we have to be a bit realistic, she said, adding that they were glad the inspection went well.

“I hope that we get the approval soon but in terms of the launch, we have to be realistic because we need to wait and watch and see how things progress because the US is going through a very bad phase,” she said in an interview with CNBC-TV18.

When asked about the market size, Mazumdar-Shaw said, “Post COVID-19, there will be a huge effort to bring down healthcare costs and biosimilars are certainly going to be extremely important in this effort. I believe insulin therapies are also going to play a very important role in cost cutting and biosimilar glargine, insulins and others are going to be extremely important.”

“So, we do have an opportunity to play very strongly in this segment. It is a USD 7 billion business globally and in US itself, it is a USD 4 billion business. So from that point of view, it has a huge opportunity and it is growing. With biosimilars, the access to insulin glargine is much larger. We have a very important role to play in providing affordable access to glargine,” she said.

When asked if the number of private labs conducting COVID-19 tests would be extended and the challenges that the industry is facing in India, she replied, “Including the private labs has been a very good move on part of the government. It should have been done sooner than this. The challenge is that state government’s legislations are coming in the way. The kit issue is being resolved because a number of kits are now being produced and I don’t think we will have an issue with number of kits, as more kits are being approved.”

“The biggest worry is the way state governments are restricting private labs from testing. In Karnataka, we have cleared the way. Maharashtra has become extremely difficult. All the state governments, Maharashtra, Telangana, Gujarat, West Bengal, they have come on very heavily on to private labs. If you don’t allow private labs to test large numbers, you are defeating the purpose of including private labs into this testing arena,” she cautioned.

Talking about their biologics business target of around USD 1 billion by FY22, she said, “It is two years away. We are hoping that our business will go according to plan. There has been a lull right now because of logistics issues. I am hopeful that the COVID-19 crisis will pass sooner than later. We will work towards that target but more than anything else, this is a time for biosimilars to have a huge impact on global healthcare and that is why I remain very confident that we will have a very big role to play.”

“There is a very close cooperation going on between the government, the Centre and the private sector whether it is on the research front, whether it is on the private testing front etc. I am very pleased with that. We are all working towards developing vaccines, therapies and new antibody based serological testing, so there is a lot of that kind of work going on,” she said, adding that what COVID-19 crisis has shown us is that we have to focus on these very important areas. Infectious diseases have been neglected and ignored for too long.

“Moreover, our public health system has to be improved and there is a lot of opportunity for us to build a very robust healthcare ecosystem,” she stated.

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Expect to launch insulin glargine on time, says Biocon’s Kiran Mazumdar Shaw

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The US FDA has issued a complete response letter for insulin glargine. Kiran Mazumdar Shaw, CMD of Biocon, spoke to CNBC-TV18 about the response letter.

“The positive aspect of the complete response letter is that the agency has essentially focused on the resolution of the observations made at the pre-approval inspection in early July,” said Mazumdar Shaw.

“We have provided the corrective action preventive action (CAPA) and we had also provided an interim report on the CAPAs that has been resolved. We are confident that we will resolve the rest of the CAPAs in the next few months and thereafter we will seek approval,” she added.

About the Malaysian facility, the CMD said, “The facilities were inspected in July and we have been asked to look at some aspects of making the system a little more vigorous. Therefore, we are doing that and we are confident of implementing the CAPA that we have presented to the agency.”

“Therefore, given the fact that there are no concerns around the scientific and the clinical and the quality of the product, this is good news for us. So it’s a matter of time and we are confident that we will be in time for the market launch after 30-month hold which gets over in March,” the CMD added.

Talking about the insulin glargine launch, she said, “The potential launch time was after March 2020, which is the end of 30-month hold. There was a 30-month hold that was put on us because it’s under 505(b)(2) pathway when Sanofi started litigation us on some IP issues and based on the regulatory requirement there is a 30-month hold to resolve this. So we believe we should be on time for that.”

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Biocon stock hovers around 52-week low as its Malyasian facility undergoes inspection

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Biocon stock hovered around its 52-week low reacting to news of 12 observations being issued across three units — drug substance, drug product, device assembly — of the company’s Malaysian facility.

The inspection, which took two weeks was a PAI or a Pre-Approval Inspection. A PAI inspection is focused on investigating and approving the processes to be undertaken for manufacturing a specific product the company will supply to the United States. A successful PAI inspection leads to the approval of the drug. The inspection doesn’t include checking compliance of the whole plant but can certainly extend to it if deemed necessary by the investigators.

In Biocon’s case, the PAI inspection was focused on Biocon’s biosimilar version of diabetes drug Lantus or insulin glargine. Used for both Type 1 and Type 2 diabetes, insulin glargine is injected once a day subcutaneously. The market size of insulin glargine is around $3 billion.​

The PAI inspection was expected as Biocon applied for a change in the manufacturing site for insulin glargine from Bangalore to Malaysia. In June 2018 Biocon received a CRL or Complete Response Letter from the US Food and Drug Administration (USFDA), asking for additional information on Biocon’s request for site change to manufacture the insulin. Hence, this PAI inspection is expected to be a part of Biocon’s application to move the manufacturing of the drug to Malaysia.

The management seems confident about the 12 observations, saying that they are procedural with no data integrity issues. The remediation will be focused on shifting the plant to a non paper-based management system, according Biocon chairperson and managing director Kiran Mazumdar-Shaw.

Indeed, a confidence booster is that Biocon has resolved observations successfully in the past at its Malaysian plant. In Feb 2018, the facility received six observations from the USFDA, the remediation was successful and the company eventually received an establishment inspection report, according to people familiar with the matter.

Additionally, the company continues to be confident about the launch plan for insulin glargine. They have already launched the drug in Japan and the European Union and are sticking to their earlier timeline for commercialisation of the drug in the US by March 2020.

However, while the management is confident, analysts are treading cautiously. The street is factoring in around $100-200 million sales for Biocon within a year or two of launch with peak sales in 3 to 4 years. Any delay in approval could disrupt these estimates.

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Novel pill could replace injections to deliver insulin, says study

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Researchers have developed a drug capsule that could be used to deliver oral doses of insulin, potentially replacing injections for patients with Type-2 diabetes, says a new study.

About the size of a blueberry, the capsule contains a single and small needle made of compressed insulin, which is injected after the capsule reaches the stomach.

The study showed that the capsule could deliver enough insulin to lower blood sugar to levels comparable to those produced by injections given through skin. They also demonstrated that the device can be adapted to deliver other protein drugs.

“We are really hopeful that this new type of capsule could someday help diabetic patients and perhaps anyone who requires therapies that can now only be given by injection or infusion,” said Robert Langer, Professor at the Koch Institute for Integrative Cancer Research in Britain.

The tip of the needle is made of nearly 100 per cent compressed, freeze-dried insulin.

When the capsule is swallowed, water in the stomach dissolves the sugar disk, releasing the spring and injecting the needle into the stomach wall.

The stomach wall has no pain receptors, so the patients would not be able to feel the prick of the injection. To ensure that the drug is injected into the stomach wall, the researchers designed their system so that no matter how the capsule lands in the stomach, it can orient itself so the needle is in contact with the lining of the stomach.

The findings, published in the journal Science, showed that the researchers could successfully deliver up to 300 micrograms of insulin.

More recently, they have been able to increase the dose to 5 milligrams, which is comparable to the amount that a patient with Type-2 diabetes would need to inject.

Furthermore, no adverse effects from the capsule was found, which is made from biodegradable polymer and stainless steel components.

Importantly, this type of drug delivery could be useful for any protein drug that normally has to be injected, such as immunosuppressants used to treat rheumatoid arthritis or inflammatory bowel disease and may also work for nucleic acids such as DNA and RNA, according to the researchers.

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Millions left behind as diabetes drives surge in insulin demand

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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A global diabetes epidemic is fuelling record demand for insulin but tens of millions will not get the injections they need unless there is a dramatic improvement in access and affordability, a new study concluded on Wednesday.

Diabetes — which can lead to blindness, kidney failure, heart problems, neuropathic pain and amputations — now affects 9 percent of all adults worldwide, up from 5 percent in 1980.

The vast majority have type 2 diabetes, the kind linked to obesity and lack of exercise, and cases are spreading particularly rapidly in the developing world as people adopt more Western, urban lifestyles.

Researchers said the amount of insulin needed to effectively treat type 2 diabetes would rise by more than 20 percent over the next 12 years, but insulin would be beyond the reach of half the 79 million type 2 diabetics predicted to need it in 2030.

The shortfall is most acute in Africa, where the team led by Dr Sanjay Basu from Stanford University estimated supply would have to rise sevenfold to treat at-risk patients who had reached the stage of requiring insulin to control their blood sugar.

“These estimates suggest that current levels of insulin access are highly inadequate compared to projected need, particularly in Africa and Asia,” Basu said.

“Despite the U.N.’s commitment to treat non-communicable diseases and ensure universal access to drugs for diabetes, across much of the world insulin is scarce and unnecessarily difficult for patients to access.”

Global insulin supply is dominated by three companies — Novo Nordisk, Sanofi and Eli Lilly — which have various programmes to try to improve access to their products.

Insulin, however, remains costly and prices can be especially out of reach in poorer countries where tortuous supply chains and high mark-ups by middlemen often make it unaffordable for many patients.

Overall, Basu and colleagues calculated that global insulin use was set to rise to 634 million 1,000-unit vials by 2030 from 526 million in 2018.

Their study, published in the Lancet Diabetes & Endocrinology journal and funded by the Helmsley Charitable Trust, was based on projections of diabetes prevalence from the International Diabetes Federation.

Dr Hertzel Gerstein from Canada’s McMaster University wrote in an accompanying commentary that it was important to estimate and ensure insulin supplies, but added the forecasts should be treated cautiously as they were based on mathematical models.

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow