Latest news with #insulin
Washington Post
3 days ago
- Health
- Washington Post
Why you should eat breakfast early
Well+Being Why you should eat breakfast early May 31, 2025 | 4:11 PM GMT Our bodies release insulin in the morning and melatonin in the evening — key factors in how much our blood sugar can spike after a meal. What the science says about intermittent fasting Related
Forbes
26-05-2025
- Business
- Forbes
Meet India's Self-Made Biologics Brewmaster Billionaire
Kiran Mazumdar-Shaw's booming drug business started not in a laboratory but in a tin-roofed shed in Bengaluru, the city formerly known as Bangalore and the capital of the southern Indian state of Karnataka. Inside, the 25-year-old was using the knowledge she had learned studying beer brewing in Australia to ferment enzymes for customers like Ocean Spray cranberry juice. Originally, she had wanted to be like her father, who was the head brewmaster at United Breweries, the big Indian firm now owned by Heineken and famous for its Kingfisher beer. But it was 1978, and she couldn't find a job. No one wanted to hire a woman as a brewer. Distraught and disillusioned, Mazumdar-Shaw put her education to another use: making enzymes for industrial uses. In partnership with an Irish entrepreneur who owned a company called Biocon and was looking to expand to India, she set up shop inside that hot shed. 'I call myself an accidental entrepreneur,' she says. The business became successful enough that Unilever bought it in the 1980s along with its Irish parent. Mazumdar-Shaw stayed on to run the unit from Bengaluru until 1998, when she and her late husband, John Shaw, bought back Unilever's stake for about $2 million. It was a steal: She would eventually sell the enzymes business to Denmark's Novozymes for $115 million in 2007. By then she had bigger things in mind. In 2000, Biocon began brewing up pharmaceuticals, starting with insulin. Insulin is a type of 'biologic,' or a drug derived from a living source, traditionally a modified version of E. coli bacteria in insulin's case (Biocon uses yeast). The company's India base enabled it to make these biologics cheaper than big Western pharma outfits. Insulin is one of the simplest biologics, which are increasingly used to treat everything from cancer to immune system disorders. More complicated biologics like gene therapies and monoclonal antibodies are difficult to make—and extremely expensive. One drug for children with spinal muscular atrophy, for instance, costs more than $2 million for the one-dose treatment. It's an enormous market, but exactly how big is impossible to say. Biologics accounted for $324 billion in spending at list prices in 2023, according to health care research firm Iqvia, but that number doesn't account for the significant rebates that branded drugmakers often offer to keep their market share, lowering what insurers and patients pay but obfuscating total costs. 'These are very complex, expensive drugs, and therefore it's important that companies like ours focus on affordable access,' says Mazumdar-Shaw over tea served by a butler at her Manhattan apartment, which is adorned with landscapes by Scottish artists George Devlin and Archie Forrest. Mazumdar-Shaw, now 72, started out in the Indian market but now sells drugs globally—and is increasingly focused on the U.S. and Canada, which represent some 40% of its biologics sales. She realized early that finding a cheaper way to make such complex, life-saving drugs not only made them more accessible but was also good business. Today, Biocon, which is publicly traded in India, brings in $1.9 billion in revenue by selling dozens of generic drugs and 'biosimilar' medications. The company also does contract research for other companies through its publicly traded subsidiary Syngene. While Forbes' Self-Made Women list includes only women from the United States, Mazumdar-Shaw would easily make the top 20 were she American. She is one of the world's wealthiest self-made female entrepreneurs, with a fortune that Forbes estimates to be $3.2 billion. The biggest part of her empire is a majority-owned private subsidiary called Biocon Biologics, which focuses on biosimilars and represents nearly 55% of the parent company's revenue. Akin to what generics are for chemically synthesized drugs, these cheaper alternatives mimic biologic drugs. As with generics, companies like Mazumdar-Shaw's are allowed to develop biosimilars after a brand-name drug's patents expire. Though biosimilars are much more expensive to make than generics, requiring more than $100 million to develop, they can drastically reduce patient costs. Iqvia estimates biosimilars have saved the U.S. health care system $36 billion at list prices since 2015. With 118 more biologic drugs set to lose patent protection by 2035, the market for their cheaper mimics could be about to boom. 'Even in the U.S. now, the adoption of biosimilars is becoming far greater because health care costs are spiraling out of control, and anything you can do to rein in costs is going to be very important,' Mazumdar-Shaw says, adding: 'We have a huge opportunity to build a very large business.' Consider one of the company's newest drugs: a cheaper alternative to the blockbuster autoimmune disease therapy Stelara, which was Johnson & Johnson's top-selling drug last year, bringing in over $10 billion in revenue. Before rebates, it costs more than $25,000 per dose and is meant to be taken every eight weeks by Crohn's disease patients and every 12 weeks by those with psoriasis. Biocon's Yesintek, launched in February, does the same job for just under $3,000 per dose—roughly 90% less than Stelara. In all, Mazumdar-Shaw's company has debuted nine biosimilar drugs, including one that mimics AbbVie's rheumatoid arthritis drug Humira (whose sales peaked at $21 billion in 2022) and another that's like Genentech's breast cancer drug Herceptin, which she launched in 2017 after a friend was diagnosed and struggled to afford the course of treatment. Herceptin cost nearly $90,000 at its peak in 2019, according to a study in JCO Oncology Practice. Seven of Biocon's biosimilar drugs have been approved for U.S. use. Biocon Biologics is up against Basel, Switzerland–based Sandoz ($10 billion in revenue), Korean firms Samsung Biologics (some $3.2 billion in sales) and Celltrion (around $2.5 billion in revenue) and even major pharmaceutical companies like Amgen, whose biosimilar for Stelara recorded $150 million in revenue in the first quarter. Its market share is especially high in emerging markets, in which many of its biosimilars command an 80% share. The American market is tougher, but it's so much larger that even a 10% or 20% share of a blockbuster drug can be worth hundreds of millions. One reason the U.S. is so difficult is that drugmakers must convince America's behind-the-scenes gatekeepers—pharmacy benefit managers—that their drugs are worth placing on the lists of approved drugs, known as formularies. With its manufacturing concentrated in India and Malaysia, Biocon must also contend with potentially large Trump tariffs (currently threatened at 25%) on pharmaceuticals made abroad. 'There's a lot of reasons why we've seen it be more difficult than we'd want for biosimilars to come to market,' says Benjamin Rome, a health policy researcher at Harvard Medical School, adding, 'The prices for generics are much more transparent. There's largely no rebates and no gaming there.' But Mazumdar-Shaw has a track record for overcoming challenges—and ignoring conventional wisdom. When she first decided to produce insulin in India 25 years ago, she faced a market that imported only animal insulins. Although human versions were better and available, they cost about 10 times more. 'I said, 'This is crazy,' ' she recalls. 'Just because we cannot afford human insulin, we are having to use animal insulin, so let me do something about it.' At the time, Biocon was still making industrial enzymes and had no experience in the drugmaking business. But within four years, it had developed India's first human insulin, making it possible for millions of diabetics who needed insulin treatment to get better drugs. 'That is what then gave me the raison d'être to focus on biopharmaceuticals,' she says. Today, Biocon has 20 drugs in oncology, immunology, diabetes and ophthalmology either on the market or in the works globally. It also introduced its first GLP-1 biosimilar for diabetes and obesity in the United Kingdom and anticipates coming to the U.S. when popular drugs like Ozempic come off patent. Mazumdar-Shaw is confident she can commercialize a drug every year in the U.S. or Europe from now until 2030. Biocon plans to launch a biosimilar to Regeneron's blockbuster eye disease drug Eylea ($10 billion in 2024 sales) later this year. She hopes to spin off Biocon Biologics into a separate public company in the next 18 months. 'I believe we are in a humanitarian business,' she says, 'and I think we are doing our bit for affordable access, which is what we want.'
Yahoo
20-05-2025
- Business
- Yahoo
Eris Lifesciences Ltd (NSE:ERIS) Q4 2025 Earnings Call Highlights: Robust Revenue Growth Amidst ...
Release Date: May 19, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Eris Lifesciences Ltd (NSE:ERIS) reported a 28% year-on-year growth in consolidated operating revenue for Q4, reaching INR 705 crores. The company achieved a significant 70% year-on-year growth in consolidated EBITDA, amounting to INR 252 crores. Eris Lifesciences Ltd (NSE:ERIS) saw a 28% growth in profit after tax, totaling INR 102 crores for the quarter. The company reported a strong operating cash flow to EBITDA ratio of 111% in Q4. The return on capital employed (ROCE) improved to 15% for FY25, up from 11% in the previous year, with an adjusted ROCE of 20%. There was a significant product shortage in human insulin, resulting in an estimated sales loss of around INR 50 crores. The critical care segment experienced a planned 20% decline, attributed to delays in building out the domestic go-to-market strategy. The company faced challenges in the oncology business due to product mix issues, impacting performance. Insulin fill-in took longer than anticipated, affecting the rollout of certain products. The company experienced intermittent connection issues during the earnings call, leading to unclear communication at times. Warning! GuruFocus has detected 8 Warning Signs with NSE:ERIS. Q: Can you clarify the impact of the supply shortage on the insulin business and the expected market capture? A: We experienced a sales loss of around INR 50 crore due to supply shortages, with INR 38 crore within the Biocon One business. We are confident in capturing 50-60% of the vacated market, supported by a secured supply deal and upcoming capacity expansions. (Respondent: Unidentified_3) Q: What are the challenges faced in the critical care business, and how do you plan to address them? A: The critical care segment faced issues due to a lack of market strategy and bandwidth. We are working on improving our go-to-market strategy and expect to see improvements in the next quarter. (Respondent: Unidentified_3) Q: Why is there a discrepancy in the expected margin improvements despite significant growth in the insulin business? A: The expected margin improvements are tempered by the timing of cartridge production, which will start in Q4, and the addition of 300 new employees, which initially strains the EBITDA line. We are cautiously guiding a 37% margin. (Respondent: Unidentified_3) Q: How does Eris plan to fill the gap left by Novo's exit from the insulin cartridge market? A: We believe the substitutes offered by Novo are either reverting to vials or are significantly more expensive. We expect to capture a significant portion of the market due to our competitive pricing and established brands. (Respondent: Unidentified_3) Q: What are the next steps for Swiss Parentals in terms of export opportunities and CDMO contracts? A: We are awaiting N visa approval, which will open large markets for us. We are in discussions for CDMO contracts, focusing on specialty injectables for EU clients, with plans to expand into oral solids. (Respondent: Unidentified_3) For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Medscape
14-05-2025
- Health
- Medscape
Primary Care's Evolving Role in Diabetes Technology
It's been more than a century since insulin was discovered, radically changing the course of diabetes treatment. Research continues to yield advances in treatments to help people better manage their diabetes and live healthier, longer lives. Newer medications, like glucagon-like peptide 1 receptor agonists, tend to get all the press, but technology also fosters innovation. This is good news for every healthcare professional caring for patients with diabetes, including primary care providers, as the number of people with diabetes continues to rise. 'I think it's important to be aware of what is available, so we can steer our patients in the right direction,' said Sos Mboijana, MD, a primary care physician and assistant chief medical information officer at Mid-Atlantic Permanente Medical Group in Washington, DC. Continuous Glucose Monitoring (CGM) As a Game Changer Insulin discovery was only the first step. Over the years, scientists continued to explore new treatments and devices that could help people manage their diabetes, including the first blood glucose test strip in 1965, followed by the first electronic meter for self-monitoring of blood glucose in 1970. The introduction of the CGM system proved to be one of the biggest game changers. 'As a diabetes doctor, I can't imagine managing a patient with diabetes without it,' said Anne Peters, MD, professor of medicine at the Keck School of Medicine of University of Southern California in Los Angeles. First approved by the US Food and Drug Administration in 1999, CGM allowed people with diabetes to forgo the multiple daily finger pricks to measure their blood glucose levels. As one of its 'Standards of Care in Diabetes,' the American Diabetes Association now recommends offering CGM to patients at the outset of a diabetes diagnosis that requires insulin. 'Continuous glucose sensors have changed the world of diabetes — absolutely,' said Natalie J. Bellini, DNP, assistant professor of medicine at Case Western Reserve University (CWRU) in Cleveland. Even people with diabetes who do not require insulin therapy now use a CGM device. Some use them all the time, while others use intermittently, according to Bellini, who also serves as a program director for diabetes technology at CWRU's Case Center for Diabetes, Obesity and Metabolism. Because CGM also allows patients to watch their blood sugar levels rise and fall in real time, it can inspire quicker behavioral changes. People can now obtain a CGM device over the counter on their own, which may also prompt people with prediabetes to make positive lifestyle shifts. 'The rise of continuous glucose monitoring has been great for those who are diabetic, and even those who are not, because it gives patients real-time data into their blood sugars and how certain foods can affect it,' said Neal Patel, DO, a family medicine physician with Providence St. Joseph Hospital Orange, Orange, California. 'For example, an apple may only mildly increase sugar levels in one person, whereas it might spike it in others.' Patients frequently tell Sarah Tucker Marrison, MD, a primary care physician in Charleston, South Carolina, that they've made changes to their diet based on noticing how certain food choices affected their blood sugar levels. 'I just appreciate when patients are proactive in terms of making changes and responding to some of the information that's available to them to best support their own health,' she said. Said Mboijana, 'It gets us over the hill with patient engagement.' More Advancements and Challenges As technology has evolved, more options have opened for patients with diabetes, especially those who need insulin. For example, the advent of the automated insulin delivery (AID) system — which is also called a 'bionic pancreas' — uses CGM-informed algorithms to communicate with a CGM device and automatically guides the delivery of insulin. With this type of a device, a patient with type 1 diabetes no longer has to make all the decisions about giving themselves insulin, removing a significant burden from the patient, said Boris Kovatchev, PhD, director of the Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia. The center conducted research that led to the creation of an artificial pancreas system called Control-IQ. 'This is the best therapy of the moment,' he said of the artificial pancreas technology. The authors of a recent study in The New England Journal of Medicine suggested AID systems could also be beneficial for patients with type 2 diabetes who need insulin. Their research showed that patients who used AID systems experienced a larger drop in their A1c levels than patients who only used CGM systems. Currently, many primary care providers say they don't typically manage insulin pumps, including those used as part of an AID system, choosing instead to refer those patients to endocrinologists. 'Those are better suited by practices that are constantly using this kind of resource,' said David Baidal, MD, an endocrinologist with University of Miami Health System and an assistant professor of medicine in the Division of Endocrinology, Diabetes and Metabolism at the University of Miami Miller School of Medicine. He noted that primary care providers are already strapped for time; managing multiple devices — including downloading the data and using it to make adjustments during clinical visits — may not be feasible for them. But primary care providers do care for many patients who use CGM devices, and one of the biggest challenges for providers is dealing with the amount of data they now have access to, said Mboijana. 'How do you manage that data?' he said. 'What do you do with it? A fire hydrant of data doesn't really help you unless you have a system to deal with it.' Not every primary care practice has the resources — including the time or dedicated staff — to download and pore over the data, agreed Bellini. 'It's a little more hit or miss,' she said. On the Horizon While many physicians say they're grateful for the advances that are already in use, they also look forward to the future, when cost is no longer a barrier for current technologies. The ADA reported that CGM is still less accessible for certain groups of people, including older patients, Black patients, and patients with Medicaid. Hybrid closed-loop AID systems are increasingly being integrated into clinical practice, but cost is still an issue for many patients who could benefit from using this technology. Physicians and other diabetes specialists also anticipate even better technologies that may become available. For instance, each year, the International Conference on Advanced Technologies & Treatments for Diabetes brings together experts focused on pioneering efforts in the field. The 2025 conference in March included sessions on innovative technologies and research, such as a session that spotlighted research on thioredoxin-interacting protein in pancreatic islet biology and the investigational novel oral therapy TIX100 that's currently in clinical trials. Baidal suggested that newer algorithms for AID systems may also be able to provide more precise insulin adjustments and help patients spend more time in their target blood glucose range. Glucose-sensitive insulin, or glucose-responsive insulin, could also improve glycemic control and reduce the incidence of hypoglycemia. Mboijana said he's looking forward to seeing how artificial intelligence may contribute in the future. 'Embrace the technology that's coming down the pike,' he said. 'Be aware of what's happening.'
Bloomberg
13-05-2025
- Health
- Bloomberg
Novo Insulin Pen Retreat Risks Drug Access to Kids with Diabetes, Report Says
Takeaways NEW Novo Nordisk A/S's decision to stop making insulin pens will narrow treatment options for children with diabetes unless non-patented drugmakers such as Biocon Ltd. step in to plug the gap in a $34 billion market. The Danish drugmaker has started phasing out the easy-to-use insulin pens in some countries, including India, forcing young people to shift to less user-friendly options such as vials and syringes, according to a report by Access to Medicine Foundation, an organization backed by the Gates Foundation and tracking global health-care inequity.
