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Is There A Generic Version Of Lantus?

Sanofi: Confronting Lantus Patent Expiry With More Efficient Successor Toujeo

Sanofi: Confronting Lantus Patent Expiry With More Efficient Successor Toujeo

Summary Sanofi received the US FDA’s acceptance for reviewing its New Drug Application for investigational basal insulin, Toujeo. The filing was also accepted by the EMA for EU countries. Sanofi submitted a lawsuit against Eli Lilly for infringing seven patents related to insulin and insulin-injecting devices. This lawsuit trial will keep Lantus’s generic version off market until mid-2016. Toujeo is an improved version and has triple concentration of insulin glargine as Lantus. Prevailing hindrances that are blocking Sanofi’s rivals from entering diabetes basal insulin market, where it has 80% market share, is likely to help Sanofi in sustaining its market lead. Sanofi (NYSE:SNY) has transformed into a company positioned for sustainable growth through its growth platforms i.e. emerging markets, diabetes solutions, vaccines etc and has a burgeoning late-stage pipeline of new biologics. Recently, the company has been striving hard to replace its star diabetes drug Lantus which is set to lose its patent in February 2015. Putting in day and night of strenuous efforts, the company received the US Food and Drug Administration's "FDA" acceptance for reviewing the company's New Drug Application "NDA" for investigational basal insulin, Toujeo. The filing was also accepted by the European Medicines Agency "EMA" for EU countries. Blocking Eli Lilly US Lantus is the world's most widely prescribed insulin. The drug garnered $7.78 billion in sales revenue in the fiscal year 2013. The loss of exclusivity of Lantus in February 2015 is a cause of concern for the company as it contributed a significant portion (19.1%) of the total sales revenue last year. However, Sanofi and Eli Lilly have been working on experimental insulin therapies to replace it. Lantus, the patent protected di Continue reading >>

Break Up The Insulin Racket

Break Up The Insulin Racket

ONE of my patients — whom I will call Mrs. B — is a 78-year-old who has had Type 2 diabetes for over 30 years. She takes several injections of insulin each day. Her blood sugars have been running too high, but she doesn’t want to increase the dose of her insulin. She told me she simply can’t afford to. Insulin has been around for almost a century. The World Health Organization considers it an essential medicine, which means it should be available “at a price the individual and the community can afford.” So why is this product increasingly too expensive for many Americans? In the United States, just three pharmaceutical giants hold patents that allow them to manufacture insulin: Eli Lilly, Sanofi and Novo Nordisk. Put together, the “big three” made more than $12 billion in profits in 2014, with insulin accounting for a large portion. What makes this so worrisome is that the big three have simultaneously hiked their prices. From 2010 to 2015, the price of Lantus (made by Sanofi) went up by 168 percent; the price of Levemir (made by Novo Nordisk) rose by 169 percent; and the price of Humulin R U-500 (made by Eli Lilly) soared by 325 percent. To make insulin affordable, we need more competition. Nothing would do this faster than a “generic” form of insulin. (Technically, because insulin is made using bacteria, it should be referred to as a “biosimilar” instead of a “generic.”) Unfortunately, there isn’t one available in the United States. This is true, in no small part, because the big three have cleverly extended the lives of their patents, making incremental “improvements” to their insulin. It’s not clear whether the newer insulin products are significantly safer or more effective than their predecessors, yet the strategy has been effec Continue reading >>

The Future Of Insulin: A List Of New Insulin Formulations Under Development

The Future Of Insulin: A List Of New Insulin Formulations Under Development

Here you can find a summary of most known insulin formulations under development. We also mention insulins which have recently appeared on the market. Novo Nordisk Europe USA FIAsp (NN-1218): an ultra-rapid-acting formulation of NovoLog / NovoRapid (insulin aspart). Phase III clinical trials Can be ready in 2016 Tresiba (insulin degludec): ultra-long acting basal insulin, lasts 42+ hours, with flexible time of dosing. Day-to-day variability is 20%. launched in 2013 approved in Sep 2015. Expected launch: Q1 2016 Ryzodeg 70/30 (insulin degludec / insulin aspart): pre-mixed basal-bolus formulation. same as above On EASD 2015, Novo presented materials from clinical trials for these insulin formulations. Novo Nordisk also explores using Victoza for type 1 diabetes (LATIN T1D trial). From the current R&D pipeline of Novo Nordisk: two more insulin formulations are at a very early phase (Phase I) of clinical trials: LAI338 (NN1438) – long-acting basal for daily administration LAI287 (NN1436) – long-acting basal intended for once-weekly dosing Novo Nordisk are interested in bringing more value to their products with new hardware/software technology: Device Research & Innovation (DRI-US) vision to explore and develop new technology, product ideas, and game-changers that may hold the potential to add value to patients and Novo Nordisk in the future within therapeutic areas covered by Novo Nordisk corporate strategy. Lilly Europe USA Abasaglar / Basaglar (insulin glargine biosimilar): cheaper analogue of Sanofi’s Lantus Approved in Sep 2014. Launched in Aug 2015 (UK). Launch postponed to December 15, 2016 after a patent dispute with Sanofi ultra-rapid insulin Phase I clinical trials Recently, Lilly has cancelled plans to release their new basal insulin Peglispro because of li Continue reading >>

Fda Approves Basaglar, The First “follow-on” Insulin Glargine Product To Treat Diabetes

Fda Approves Basaglar, The First “follow-on” Insulin Glargine Product To Treat Diabetes

Release The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. According to the Centers for Disease Control and Prevention, approximately 21 million people in the United States have been diagnosed with diabetes. Over time, diabetes increases the risk of serious health complications, including heart disease, blindness, and nerve and kidney damage. Improvement in blood sugar control can reduce the risk of some of these long-term complications. “Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and today’s approval is expected to expand the availability of treatment options for health care professionals and patients,” said Jean-Marc Guettier, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. Basaglar is the first insulin product approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act. A 505(b)(2) application was submitted for Basaglar that relied, in part, on the FDA’s finding of safety and effectiveness for Lantus (insulin glargine injection) to support approval. The applicant demonstrated that Basaglar was sufficiently similar to Lantus to scientifically justify reliance, and also provided Basaglar-specific data to establish the drug’s safety and efficacy for its approved uses. The Basaglar-specific data included two clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus respectively. Dosing of Basaglar should be individualized based on th Continue reading >>

Sanofi Hits Merck With Patent Suit Over New Diabetes Drug

Sanofi Hits Merck With Patent Suit Over New Diabetes Drug

Law360, San Francisco (September 19, 2016, 10:53 PM EDT) -- French pharmaceutical giant Sanofi-Aventis US Inc. sued Merck & Co. Inc.'s overseas unit in Delaware federal court Friday, alleging the rival pharmaceutical company developed a diabetes drug that infringes 10 patents for its top-selling Lantus insulin product and its SoloStar injection pen. The suit alleges Merck Sharp & Dohme Corp. intentionally developed its new insulin drug, MK-1293, using Sanofi’s patented products in order to harm Sanofi’s Lantus sales. It seeks a permanent injunction barring Merck from developing drugs that infringe Sanofi patents. “The acts of infringement... Continue reading >>

Mylan To Develop Lantus, Humalog And Novolog Generics

Mylan To Develop Lantus, Humalog And Novolog Generics

Mylan has set its sights on bringing generic versions of three top-selling insulin brands to market. The company has signed a collaboration deal with Biocon to develop and commercialise the Indian biotech firm's versions of Sanofi's Lantus, Lilly's Humalog and Novo Nordisk's NovoLog. Together the three 'fast-acting' insulin brands are worth approximately $11.5bn and all three are expected to lose patent protection in the next couple of years. Mylan hopes its deal with Biocon will allow it to be one of the first companies to launch generic versions of the insulins in developed pharma markets like the US. Mylan's CEO Heather Bresch said: "This collaboration further expands and diversifies our pipeline of complex, difficult-to-manufacture products with strong future growth potential. “Importantly, we believe we have the opportunity to be one of the first generic entrants in developed markets into the rapidly growing diabetes area, helping to address unmet needs and reduce the economic burden to those battling the disease and to the global healthcare system." The collaboration, which adds to the US generics company's existing generic biologics partnership with Biocon, will see the firms share development, capital and certain other costs in order to bring the products to market. Mylan will then have exclusive commercialisation rights in the US, Canada, Australia, New Zealand, the EU and European Free Trade Association countries through a profit-share arrangement with Biocon. Mylan will also have co-exclusive commercialisation rights with Biocon in certain other markets around the world. Biocon's chairman and managing director Kiran Mazumdar-Shaw said: "We are confident that together we can build a strong global presence in generic insulin analogs and provide access to affo Continue reading >>

Mylan Patent Win For Lantus Copy Looks Unlikely To Speed Market Entry

Mylan Patent Win For Lantus Copy Looks Unlikely To Speed Market Entry

Mylan patent win for Lantus copy looks unlikely to speed market entry A U.S. patent appeal board has handed Mylan a small win in the generic drugmaker's efforts to bring to market a copycat version of Sanofi's blockbuster insulin product Lantus, but ongoing litigation in federal court between the two companies remains a hurdle to any product launch. Ruling in favor of Mylan, the U.S. Patent Trial and Appeal Board found Sanofi's claims contained in two formulation patents on Lantus to be unpatentable, Mylan announced Thursday . The decision comes roughly 18 months after Mylan filed petitions for a so-called inter partes review of the two patents. While Mylan was quick to tout the ruling as a "key milestone" for the generic version of Lantus it's developing with Biocon, it remains unclear whether the PTAB's decision will accelerate a potential launch. Sanofi filed a patent infringement case against Mylan in October 2017, which remains pending in the U.S. District Court for the District of New Jersey. Due to the ongoing litigation, approval of Mylan and Biocon's copycat is subject to a 30-month stay which extends to early 2020. Sanofi already faces direct competition to Lantus (insulin glargine) in the U.S., where Eli Lilly won approval of its follow-on biologic Basaglar in 2014 and launched the rival drug in December 2016. Declining sales for Lantus offer some proof that the French drugmaker has begun to feel the effects, particularly after CVS and UnitedHealthcare removed Lantus from their formularies in favor of Basaglar. Payer pressure on insulin pricing has also played a role, forcing diabetes drugmakers like Sanofi to extend greater rebates on their products to protect market share. That said, Lantus remains a multi-billion dollar franchise for Sanofi. In theory, su Continue reading >>

Lantus (insulin Glargine) Side Effects

Lantus (insulin Glargine) Side Effects

What Is Lantus (Insulin Glargine)? Lantus is the brand name of insulin glargine, a long-acting insulin used to treat adults and children with type 1 diabetes mellitus and adults with type 2 diabetes mellitus to control high blood sugar. Lantus replaces the insulin that your body no longer produces. Insulin is a natural substance that allows your body to convert dietary sugar into energy and helps store energy for later use. In type 2 diabetes mellitus, your body does not produce enough insulin, or the insulin produced is not used properly, causing a rise in blood sugar. Like other types of insulin, Lantus is used to normalize blood sugar levels. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual dysfunction. Proper control of diabetes has also been shown to reduce your risk of a heart attack or stroke. Lantus is meant to be used alongside a proper diet and exercise program recommended by your doctor. Lantus is manufactured by Sanofi-Aventis. It was approved for use by the Food and Drug Administration (FDA) in 2000 as the first long-acting human insulin administered once a day with a 24-hour sugar-lowering effect. Lantus Warnings You will be taught how to properly inject this medication since that is the only way to use it. Do not inject cold insulin because this can be painful. Always wash your hands before measuring and injecting insulin. Lantus is always clear and colorless; look for cloudy solution or clumps in the container before injecting it. Do not use Lantus to treat diabetic ketoacidosis. A short-acting insulin is used to treat this condition. It is recommended that you take a diabetes education program to learn more about diabetes and how to manage it. Other medical problems may affect the use of this Continue reading >>

How To Get Insulin At A Cheaper Price

How To Get Insulin At A Cheaper Price

Insulin can be expensive. If you’re one of the 6 million Americans with diabetes relying on this main-stay treatment, you could be paying out-of-pocket costs anywhere from $120 to $400 per month, according to a 2015 New England Journal of Medicine commentary. Drugs such as Lantus (insulin glargine) and Levemir (insulin detemir) have seen significant cost increases, according to a recent trend report by pharmacy benefit manager Express Scripts. One reason for the high prices is the lack of generic options for insulin. So for now, you’re stuck having to search around to find affordable options. Where do you shop for more affordable insulin? For some people though, high drug costs can mean making difficult financial choices. Our national polls show people might cut back on groceries and paying bills to pay for their medications. To minimize your costs, consider these options: Prescription Assistance Programs If you don’t have health insurance or are without drug coverage, look into applying for a patient assistance program (PAP). Through the nonprofit NeedyMeds, you can find some programs that offer free or low-cost insulin as long as you meet the eligibility requirements. Those are usually based on your insurance status, income, and diagnosis. You might also qualify for a diagnosis-specific program that can help you save on syringes, pumps, and other diabetes supplies. Pharmacists are also a great resource and can help you find a PAP that meets your financial needs. Switch Drugs Another way to save is by asking your doctor whether there’s a lower-priced insulin that’s right for you. While “long-acting” is a more popular type of insulin, it's also more expensive, but that doesn’t necessarily mean it works better. “It’s mostly a marketing ploy,” says M Continue reading >>

‘generic’ Basaglar Is Cheaper Than Lantus But Does It Work?

‘generic’ Basaglar Is Cheaper Than Lantus But Does It Work?

Basaglar U-100 insulin glargine, which is a follow-on biologic insulin to Lantus is now available by prescription in the US. Basaglar, from Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, Inc. is not technically a generic to Lantus but it does have an amino acid sequence identical to Lantus and has been FDA approved as a long-acting insulin for patients of all ages with type 1 diabetes and adults with type 2 diabetes. David Kendall, M.D. and the vice president of Global Medical Affairs for Lilly Diabetes said in Lilly’s press release, “Lilly and Boehringer Ingelheim are proud to bring another proven effective diabetes treatment choice to people who may need a long-acting insulin to help control their blood sugar,” and that “We know that starting insulin can be a challenging experience for some people with type 2 diabetes. As part of our continuing commitment to the diabetes community, we are expanding our educational resources.” Is it Cheaper? Business Insider reported that Basaglar “is 15% less than the list price of Lantus and Toujeo, two long-acting insulins made by Sanofi Aventis, 21% less than the list price of Levemir, and 28% less than Tresiba, two long-acting insulins made by Novo Nordisk.” An Eli Lilly spokesperson told Business Insider that before discounts or insurance coverage, the list price for a 5-pen pack of Basaglar is $316.85. You will be able to get Basaglar from retail and mail order pharmacies. Basaglar has also been chosen for the formularies of the top three pharmacy benefit managers and is expected to be covered by many commercial insurance plans. The pharmacy benefit manager CVS Health has dropped Lantus and replaced it with Basaglar for their next year’s formulary. In their announcement, CVS Health stated that th Continue reading >>

Diabetes W/out Insurance

Diabetes W/out Insurance

Phoenix Diabetes and Endocrinology has compiled this information to help our patients manage their diabetes in the event they have lost their health insurance or have a very limited budget and cannot afford preferred therapies. Many type II diabetics can maintain good blood sugar control if they focus on diet, weight management and exercise as the primary therapy and use these cheaper medications discussed below when additional therapies are needed. Type I or insulin deficient diabetes patients will have a much harder time controlling their blood sugars with cheaper medications. Several insulin manufacturers have programs for diabetics without any health insurance to provide insulin at no charge. The forms for these programs are found at our needymeds link. For the type II diabetics: Some types of diabetes medications do not have generic alternatives. These include Byetta and Januvia as well as many of the modern insulin. These medications may need to be discontinued. Older insulins such as Novolin N and Regular human insulin work differently and will require more blood sugar monitoring to be used safely. Therefore, understand that these recommendations are based on cost considerations rather than obtaining optimal diabetes control while your financial resources are limited. Additionally, realize ignoring diabetes is not wise either. One ER visit for dehydration or infection due to poorly controlled blood sugars will be very expensive. Therefore, these recommendations are intended to help control costs, not replace needed medical care. Lab work There are many places where discounted lab work is available at less than half the cost of traditional labs. One such place is Lab Express 602-273-9000. A comprehensive metabolic panel cost $45 and hemoglobin A1c costs $65. I bel Continue reading >>

'generic' Biosimilar Insulin Becoming Reality!

'generic' Biosimilar Insulin Becoming Reality!

As our community struggles with the skyrocketing prices of insulin, new hope dawns. After screaming for years that "WE WANT GENERIC INSULIN!," we are now finally entering the long-awaited era of biosimilars (even if they aren't technically called that by U.S. regulatory leaders), that are basically similar lower-cost versions of already-approved insulins. To be clear, this is a whole new world of insulin products different from anything we've seen before. We’re not talking about those Walmart "generic" insulins that are just cheap forms of older-gen products like R, N, and 70/30 mix simply sold under Walmart’s ReliOn brand name. In contrast, these new biosimilar “generics” are actually novel formulations that copy the biological molecule of an existing insulin. As of today, Dec. 15, Eli Lilly's new Basaglar basal insulin becomes available to buy here in the U.S. This is the first so-called “follow-on” version of competitor Sanofi's successful long-acting insulin Lantus, and there’s been a ton of buzz about its potential to bring down insulin prices across the board and reshape insurance coverage. This is the first, and we expect to see a second biosim launched within a year, followed by a variety of these lower-cost insulins, both fast-acting and long-acting. You may be surprised to see that these copycat insulins are not coming from newcomers, but from established Pharma companies themselves, now that they finally have the opportunity to undercut each other as their signature insulins go off patent. But that's what it is, Folks: Insulin Wars. And although we may be caught in the middle as patients, we do have a chance to save money with the introduction of these new generics we've been demanding for so long. 'Generic' Insulins Coming Soon The three bigges Continue reading >>

Merck Takes Aim At Sanofi With A Lantus Biosimilar Of Its Own

Merck Takes Aim At Sanofi With A Lantus Biosimilar Of Its Own

Sanofi ($SNY) and its top-selling Lantus may have bought some time last month with a legal wrench in Eli Lilly's ($LLY) spokes, but now Merck ($MRK) has bulldozed its way into the conversation with plans to kick off late-stage studies for its own knockoff of the blockbuster drug, further complicating an already heated fight. Under an expanded agreement with Samsung Bioepis, a joint venture between the South Korean giant and Biogen Idec ($BIIB), Merck plans to develop MK-1293, an insulin glargine candidate that, much like Lantus, provides long-acting relief for patients with Types 1 and 2 diabetes. The pair said it plans to get started on Phase III trials for MK-1293 soon, but a Merck spokeswoman declined to provide a more detailed timeline of the drug's development path. Merck's entré further complicates the battle over Lantus, a drug whose sales grew 20% last year to bring in about $7.8 billion for Sanofi. The French drugmaker's patent doesn't expire until 2015, but the promise of a blockbuster biosimilar has competitors queuing up to take a shot. Eli Lilly appeared to be first in line as it raced to the FDA with its Lantus generic, but Sanofi's January patent infringement suit triggered a 30-month FDA delay that will likely put off Lilly's launch well into 2016. And that could be the break Sanofi needs to polish up Lantus' successor, the promising U300, and pull off a seamless transition. But if Merck can make its way to market on time for Lantus' patent loss, it'll wipe away Sanofi's previous victory and further dilute the market by the time Lilly makes its way through the regulatory process. Of course, that's assuming Sanofi and its legal team don't set their sights on MK-1293 next; the company didn't respond to a request for comment on Merck's announcement. For Me Continue reading >>

Mylan-biocon Combine’s Generic Insulin May Hit Market Sooner

Mylan-biocon Combine’s Generic Insulin May Hit Market Sooner

MYL-1501D, the biosimilar insulin being developed by US generic major Mylan and India’s Biocon, may hit the market earlier than expected as its trial data has already shown impressive results, allowing a faster approval process. The product, insulin glargin, which is a generic version of Sanofi’s human insulin brand Lantus, is currently awaiting regulatory approval in Europe and the filing is soon expected in the US and other markets. A Biocon spokesperson said the company otherwise expects the launch by financial year 2018, depending on the approval. Insulin glargin is a long-acting insulin analog used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar. The companies had on Sunday jointly presented new data from the insulin glargine clinical program at the American Diabetes Association’s 77th Scientific Sessions in San Diego. The presentation showed that trials have so far confirmed the efficacy, safety and immunogenicity of insulin glargine, in comparison to Lantus in patients with Type 1 and Type 2 diabetes. Data demonstrating pharmacokinetic and pharmacodynamic equivalence were also presented Sunday (11 June). Biocon shares in the Indian market rose at least 1.25 per cent on Monday as investors reacted positively on the impressive trial results of insulin glargine that the company hopes to launch in the market soon. The stock closed at Rs 1035.20 a unit on BSE on Monday (12 June), while the benchmark Sensex was 166.36 points down at 31095.70. Mylan and Biocon had last year said that the European Medicines Agency (EMA) accepted Mylan's Marketing Authorization Application (MAA) for insulin glargine for review. The companies, which have co-developed insulin g Continue reading >>

Is There A Generic Version Of Lantus Solostar

Is There A Generic Version Of Lantus Solostar

11 Jan 2016 ... Will this drug be cheaper than Lantus and other insulins? ... “Generic” versions of drugs in the US typically come at a 50-80% discount to the original product. ... are working on their own biosimilar insulin glargine products. 22 Dec 2016 ... Basaglar U-100 insulin glargine, which is a follow-on biologic insulin ... people who may need a long-acting insulin to help control their blood sugar ... stand against egregious drug price increases that unnecessarily add costs ... 22 Dec 2014 ...There will be diabetics who will go without insulin and they can't,” Clark says. ... Generics are the wild card when it comes to insulin prices. ... patients will pay no more than $25 on up to 3 Lantus SoloSTAR pen prescriptions, ... Keterangan foto: Ion Ficior. 87 tahun mantan pejabat Partai Komunis Rumania telah dijatuhi hukuman 20 tahun penjara. (foto internet)Seorang komandan penjara pada masa pemerintahan Partai Komunis Ruman Continue reading >>

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