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Mylan And Biocon Get Approvals For Biosimilar Insulin Glargine In Europe And Australia

Mylan And Biocon Get Approvals For Biosimilar Insulin Glargine In Europe And Australia

Mylan and Biocon Get Approvals for Biosimilar Insulin Glargine in Europe and Australia The European approval marks the first approval for a biosimilar in that region resulting from the companies joint portfolio. Mylan and Biocon have received marketing authorization approval from the European Commission (EC) for Semglee 100 units/mL 3-mL prefilled disposable pen, a biosimilar insulin glargine for treating diabetes, the companies announced on Mar. 27, 2018. Semglee is the first biosimilar resulting from Biocon and Mylan's joint portfolio to be approved in Europe. In addition, the companies received approval for the product in Australia from the Therapeutic Goods Administration (TGA). "We are excited to be able to bring Mylan and Biocon's biosimilar insulin glargine to Europe and Australia where millions of people are currently living with diabetes, and we are committed to continuing to bring high quality, more affordable biosimilar products to markets around the world. The investments that we have made to develop and manufacture a leading portfolio of complex products, including Semglee, is one way that we are delivering on our commitment to expand access to high quality medicine," said Mylan President Rajiv Malik in a company press release. "The approval of Mylan and Biocon's biosimilar insulin glargine by the European Commission and TGA Australia are important milestones in our collaboration. It furthers our mission to provide a high quality, affordable insulin analog for people with diabetes globally. As a credible, global insulins player, we are committed to address the growing healthcare challenges associated with diabetes and have made significant investments in R&D and manufacturing to build scale and make our affordable insulins portfolio available in many marke Continue reading >>

The Future Of Biosimilar Insulins

The Future Of Biosimilar Insulins

Washington State University College of Pharmacy Drug Information Center, Spokane, WA Author information Copyright and License information Disclaimer Copyright 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See for details. IN BRIEF Biosimilar insulins are available in many countries and will be made available in the United States in the near future. Some concerns associated with biosimilar insulins include potential differences in the efficacy and safety between a biosimilar product and its reference insulin, the ramifications of having the same name or different names for a biosimilar and its reference insulin, the prospects of and limitations to substituting insulin products, and the proper implementation of pharmacovigilance. Still, health care providers will have the opportunity, with continued appropriate monitoring, to offer alternative, and possibly more individualized, therapy for diabetes management with the introduction of biosimilar insulins. Insulin was first discovered by surgeon Frederick Grant Banting and medical student Charles Herbert Best at the University of Toronto in a happenstance moment in 1921. In January 1922, the first patient with diabetes (14-year-old Leonard Thompson) was treated with insulin (originally termed isletin) that was successfully extracted from whole fresh animal pancreas. The insulin product was patented by the academic team in 1923, but they sold the patent for $1 per discoverer to the University of Toronto, which contracted with Eli Lilly to mass-produce purified insulin ( 1 ). The question that follows is why no generic version of insulin was marketed until 2015 (available in other countries Continue reading >>

Is Biosimilar Insulin Available?

Is Biosimilar Insulin Available?

Yes—and no. In December 2015, the Food and Drug Administration (FDA) approved the long-acting human insulin analog Basaglar (insulin glargine injection). Basaglar is similar to the insulin glargine injection Lantus, and the approval of Basaglar relied in part on the FDA’s finding of safety and effectiveness for Lantus. In Europe, the analogous product is considered to be a biosimilar. In the United States, Basaglar is not approved as a biosimilar product—the FDA refers to it as a “follow-on” insulin. So what’s up? The answer lies in a quirk of biological product approval. The term “biological product” is defined in the Public Health Service (PHS) Act as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product… applicable to the prevention, treatment, or cure of a disease or condition of human beings.” Various FDA regulations and policies have interpreted the definition to include immunoglobulin products, products containing cells or microorganisms, and most protein products. Biological products are licensed (i.e., approved) under section 351 of the PHS Act. Many therapeutic biological products also meet the definition of “drugs” under the Federal Food, Drug, and Cosmetic (FDC) Act; in fact, they are considered to be a subset of drugs. Drugs are approved under section 505 of the FDC Act. Historically, some natural source protein products have been regulated as drugs under the FDC Act, not biological products under the PHS Act. Insulin is one of those products. When human insulin (Humulin) was approved as the world’s first recombinant DNA drug product in 1982, it was approved under the FDC Act. This dichotomy continues today, with some proteins licensed under the PHS Continue reading >>

Biosimilar Insulins

Biosimilar Insulins

Go to: Abstract Until now most of the insulin used in developed countries has been manufactured and distributed by a small number of multinational companies. Beyond the established insulin manufacturers, a number of new players have developed insulin manufacturing capacities based on modern biotechnological methods. Because the patents for many of the approved insulin formulations have expired or are going to expire soon, these not yet established companies are increasingly interested in seeking market approval for their insulin products as biosimilar insulins (BI) in highly regulated markets like the EU and the United States. Differences in the manufacturing process (none of the insulin manufacturing procedures are 100% identical) can lead to insulins that to some extent may differ from the originator insulin. The key questions are if subtle differences in the structure of the insulins, purity, and so on are clinically relevant and may result in different biological effects. The aim of this article is to introduce and discuss basic aspects that may be of relevance with regard to BI. Keywords: biosimilar insulin, insulin therapy, insulin formulations, insulin antibodies, insulin analogs, insulin glargine Biopharmaceuticals (were invented in the 1980s of the past century. They are proteins derived from cell culture/fermentation processes; the first example was recombinant human insulin. Other examples are cytokines, monoclonal antibodies, and other insulins. Since a number of years biosimilar products are on the market for clinical usage, that is, “copies” of therapeutically used proteins (eg, erythropoietin, somatropin).1-3 One definition of biosimilar is “a new biological product similar to an already authorized medicine . . . similar but not identical to the bio Continue reading >>

Fda Tentatively Approves Merck's Copycat Of Sanofi's Lantus

Fda Tentatively Approves Merck's Copycat Of Sanofi's Lantus

(In this July 20 story, corrects to “follow-on biologic” from “biosimilar” in paragraphs 1, 6 and 9; removes reference to “biosimilar” throughout the story.) (Reuters) - Merck and Co Inc said on Thursday the U.S. Food and Drug Administration (FDA) tentatively approved its follow-on biologic version of French drugmaker Sanofi SA’s blockbuster diabetes treatment, Lantus. Merck’s copycat, if launched, would challenge Lantus as a cheaper alternative that could chip away at the drug’s sales, which reached 5.71 billion euros ($6.6 billion) last year and represented over a sixth of Sanofi’s total sales. Though the FDA said Merck’s product was similar enough to Lantus to justify approval, the agency’s final greenlight is subject to the resolution of a patent infringement suit brought by Sanofi against the U.S. drugmaker. The litigation, filed in September, triggered a stay on final FDA approval for up to 30 months, unless a court rules in favor of Merck earlier. After Lantus’s U.S. patent expired in 2015, Sanofi had hoped to revive diabetes drug revenue that had declined due to pricing pressure and competition, by launching a follow-on product called Toujeo in March that year. Toujeo raked in 649 million euros in sales last year. Eli Lilly & Co’s Lantus follow-on biologic, Basaglar, won tentative FDA approval in August 2014 but litigation brought by Sanofi delayed final approval to December 2016. Lilly agreed to pay Sanofi royalties as part of the settlement. Basaglar generated $86.1 million in sales last year. U.S. pharmacy benefit manager CVS in August said it would drop Lantus from the list of medicines it reimburses on behalf of health insurers, dealing a blow to the French drugmaker’s diabetes business. Merck’s Lantus follow-on biologic, cal Continue reading >>

Ema Approval For Biosimilar Insulin Glargine Semglee Posted 15/02/2018

Ema Approval For Biosimilar Insulin Glargine Semglee Posted 15/02/2018

Home / Biosimilars / News / EMA approval for biosimilar insulin glargine Semglee EMA approval for biosimilar insulin glargine Semglee Posted 15/02/2018 The European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 25 January 2018 that it had recommended granting marketing authorization for the insulin glargine biosimilar Semglee. Semglee is produced by US generics giant Mylan Pharmaceuticals (Mylan)and partner India-based biologicals specialist Biocon. The pair submitted their application for their insulin glargine biosimilar (MYL1501D) to EMA in November 2016 [1]. The product is a proposed biosimilar to Sanofis Lantus (insulin glargine), which had worldwide net sales of US$5.7 billion in 2016. The patents on Lantus expired in 2014 in both Europe and the US [2]. Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above. The CHMP has recommended that Semglee be approved for the treatment of diabetes. The positive opinion will now be referred to the European Commission, which grants marketing authorizations for medicines in the European Union. Biocon also received approval from Japans Ministry of Health, Labour and Welfare for its insulin glargine biosimilar in March 2016 [3]. Biocon and Mylan have a global partnership on biosimilars with phase III clinical trials ongoing for candidate biosimilars of adalimumab, bevacizumab, pegfilgrastim and trastuzumab [4]. Continue reading >>

Merck Wins Tentative Fda Approval For Lusduna

Merck Wins Tentative Fda Approval For Lusduna

Merck Wins Tentative FDA Approval for Lusduna Merck & Co. said today that it has won tentative FDA approval for its follow-on biologic basal insulin Lusduna Nexvue (insulin glargine injection). The approval is tentative because Sanofi has sued Merck, contending that Lusduna infringes on patents for its marketed diabetes treatment Lantus (insulin glargine). Under the Hatch-Waxman Act, the filing of that lawsuit in September 2016 automatically blocks the FDA from issuing a final approval for up to 30 months, or if the U.S. District Court in Delaware rules in favor of Merck, whichever comes sooner. The FDA also granted provisional approval for Merck to market the treatment under the trade name Lusduna Nexvue, once it reaches the market. The FDA accepted Lusduna for review in August 2016. The tentative approval of Lusduna Nexvue is an important milestone, bringing us closer to offering this medicine to patients, Sam Engel, M.D., associate vp, Merck clinical research, diabetes, endocrinology, and womens health, said in a statement. The FDA approval comes six months after Lusduna won European Commission marketing authorization on January 4 as a biosimilar drug referencing Lantus, for treatment of diabetes in patients aged at least 2 years. Lantus lost patent exclusivity in the U.S. and Europe in 2015. Since then, Sanofi has reported sales declines for the drug. Lantus finished the first quarter having generated 1.226 billion ($1.425 billion) in net sales, down 14% from the year-ago quarter. For all of 2016, Lantus sales fell 12.1% year-over-year, to 4.761 billion ($5.537 billion). In the U.S. alone, Lantus sales fell 20.9%, to 690 million (about $803 million)reflecting lower average net price, patients switching to Sanofis next-generation basal insulin formulation Toujeo (in Continue reading >>

Switching From Biosimilar (basalin) To Originator (lantus) Insulin Glargine Is Effective In Chinese Patients With Diabetes Mellitus: A Retrospective Chart Review - F1000research

Switching From Biosimilar (basalin) To Originator (lantus) Insulin Glargine Is Effective In Chinese Patients With Diabetes Mellitus: A Retrospective Chart Review - F1000research

Background: This study investigated the effectiveness and safety of switching from Basalin to Lantus in Chinese patients with diabetes mellitus (DM). Methods: A retrospective chart review conducted using the electronic medical records of patients hospitalized at the Qingdao Endocrine and Diabetes Hospital from 2005 to 2016. All patients were diagnosed with DM and underwent switching of insulin from Basalin to Lantus during hospitalization. Data collected included fasting (FBG), pre- and post-prandial whole blood glucose, insulin dose, reasons for insulin switching and hypoglycemia. Four study time points were defined as: hospital admission, Basalin initiation, insulin switching (date of final dose of Basalin), and hospital discharge. Blood glucose measurements were imputed as the values recorded closest to the dates of these four time points for each patient. Results: Data from 73 patients (70 patients with type 2 diabetes, 2 with type 1, and 1 undisclosed) were analyzed. At admission, mean glycated hemoglobin (HbA1c) and FBG were 8.9% (SD=1.75) and 9.98 (3.22) mmol/L, respectively. Between Basalin initiation and insulin switch, mean FBG decreased from 9.68 mmol/L to 8.03 mmol/L (p<0.0001), over a mean 10.8 (SD=6.85) days of Basalin treatment, and reduced further to 7.30 mmol/L at discharge (p=0.0116) following a mean 6.6 (7.36) days of Lantus. The final doses of Basalin and Lantus were similar (0.23 vs. 0.24 IU/kg/day; p=0.2409). Furthermore, reductions in pre- and post-prandial blood glucose were also observed between Basalin initiation, insulin switch and hospital discharge. The incidence of confirmed hypoglycemia was low during Basalin (2 [2.4%]) and Lantus (1 [1.2%]) treatment, with no cases of severe hypoglycemia. Conclusion: In this study population, switching f Continue reading >>

Gc Pharma Gets Korean Approval For Lantus Biosimilar

Gc Pharma Gets Korean Approval For Lantus Biosimilar

GC Pharma gets Korean approval for Lantus biosimilar [THE INVESTOR] GC Pharma confirmed on March 8 that it has attained regulatory approval to sell a copy version of Sanofis blockbuster insulin Lantus in Korea. GC Pharma -- formerly Green Cross --plans to launch Glarzia Prefilled Pen, a Lantus biosimilar developed by Indian drug maker Biocon, in the third quarter this year, a company official said on March 8. Under a license deal in 2016, GC Pharma holds exclusive sales marketing rights for Glarzia in Korea. The drug will be Koreas second biosimilar referencing the original diabetes therapy. In addition to the original, Glarzia will now compete against Basaglar, another long-acting insulin biosimilar from Eli Lilly and Boehringer Ingelheim thats sold by Eli Lilly. Basaglar was launched last April at a 14 percent discount of the original drug. It recorded some 300 million won (US$282,000) in sales last year. During the same period, Lantus sales stood at 4.62 billion euros (US$5.73 billion). Accumulated revenues over the past two years, however, have been negatively impacted by the launch of cheaper knockoffs. To fend off the growing biosimilar competition, Sanofi launched Toujeo, its own longer-acting basal insulin. Lantus currently dominates the Korean insulin injection market, which is estimated to be worth around 40 billion won. By Park Han-na ( [email protected] ) Continue reading >>

Insulin Glargin Von Mylan

Insulin Glargin Von Mylan

Weiteres Lantus-Biosimilar kurz vor der EU-Zulassung Mylan kann auf baldige Zulassung seines Insulin glargin hoffen. (Foto: 6okean / stock.adobe.com) Sanofis Basalinsulin Lantus bekommt noch mehr Konkurrenz. DerHumanarzneimittelausschuss der EMA hat nmlich ein weiteres Biosimilar zurZulassung empfohlen. Diesmal ist es dieFirma Mylan, die ein Stck vom Insulin-glargin-Kuchen haben will. Der erste Nachahmer, Abasaglar von Boehringerund Lilly, ist seit September 2015 in Deutschland auf dem Markt. Unter dem Handelsnamen Semglee will Mylan sein Insulinglargin demnchst in der EU vermarkten. Der Humanarzneimittelausschuss der EMA (CHMP) hat sich vergangene Woche fr die Zulassung des Biosimilars ausgesprochen.Das Prparat soll zur Behandlung desDiabetes mellitus bei Erwachsenen, Jugendlichen und Kindern ab zwei Jahren eingesetztwerden. Damit entsprechen die Anwendungsgebiete exakt denen des OriginalsLantus von Sanofi, das 2016 laut Arzneiverordnungsreport nicht nur das am hufigstenverordnete Basalinsulin, sondern auch mit 135,4 Millionen Tagesdosen das amhufigsten verordnete Insulinanalogon berhaupt war . Konkurrenz hat Lantus seit 2015 . Zum einen durch das Biosimilar Abasaglar. Es wurde im September 2015 eingefhrt. Der Marktanteil war aber mit6,5 Millionen verordneten Tagesdosen 2016 noch berschaubar. Kurz vor der Einfhrungvon Abasaglar hatte Sanofi selbst eine Variante seines Blockbusters Lantus aufden Markt gebracht Toujeo. Ein Insulin glargin, das 300 internationale Einheiten (I.E.)pro ml enthlt, statt nur 100 I.E. wie Lantus. Das soll zum einen fr Patienten, die sehr hohe Dosierungen bentigen, wegendes geringeren Volumens vorteilhaft sein. Zum anderen gibt es Daten von Sanofi,die darauf hindeuten, dass Toujeo bezglich des Hypoglykmierisikos gnstiger ist als Lantus. Toujeo Continue reading >>

Fda Approves New Insulin Glargine Basaglar – The First “biosimilar” Insulin In The Us

Fda Approves New Insulin Glargine Basaglar – The First “biosimilar” Insulin In The Us

Twitter Summary: 1st ever “biosimilar” insulin approved in US – potential to come cheaper than other insulins, with launch in December 2016 Lilly/BI recently announced the FDA approval of its long-awaited biosimilar insulin glargine, Basaglar, for type 1 and type 2 diabetes. Basaglar is biologically similar to Sanofi’s basal insulin Lantus (insulin glargine), including the same protein sequence and a similar glucose-lowering effect. While the FDA does not call it a “biosimilar” drug for regulatory reasons, it can essentially be thought of as an alternative form of Lantus. Pricing for Basaglar is unknown at this time (more on this below), and the drug will not be launching in the US until after December 15, 2016. Why are “biosimilar” insulin options exciting? Most notably, they could potentially be offered at lower costs than brand name insulins. Basaglar has already launched in several international countries (under the brand name Abasaglar) and is typically priced at a 15%-20% discount relative to Lantus in those markets. It’s not clear yet how the discounts for Basaglar will compare in the US, and how much less patients with insurance might pay. “Generic” versions of drugs in the US typically come at a 50-80% discount to the original product. But unlike most generic drugs, biosimilar insulins are much more expensive to manufacture, so it’s unlikely they’ll see that same level of discount in the US. Indeed, Novartis launched the first “biosimilar” drug approved in the US last September (not in diabetes), which came at a 15% discount. Still, we’ve heard great optimism that biosimilar insulin glargine will help patients facing higher insulin costs. At the IDF conference in December, Dr. Matthew Riddle suggested that of all the insulins new Continue reading >>

Gc Pharma Announces Approval For Lantus Biosimilar In Korea

Gc Pharma Announces Approval For Lantus Biosimilar In Korea

GC pharma announces approval for Lantus biosimilar in Korea GC pharma announces approval for Lantus biosimilar in Korea The company plans to launch Glarzia Prefilled Pen, a Lantus biosimilar developed by Indian drug maker Biocon, in the third quarter this year Koreas GC Pharma announced that it has attained regulatory approval to sell a copy version of Sanofis blockbuster insulin Lantus- Glarzia Prefilled Pen in Korea. This is product is the second Lantus biosimilar after Boehringer Ingelheims Basaglar. The company plans to launch Glarzia Prefilled Pen, a Lantus biosimilar developed by Indian drug maker Biocon, in the third quarter this year, an official said on March 8. Under a license deal in 2016, GC Pharma holds exclusive sales marketing rights for Glarzia in Korea. The Ministry of Food and Drug Safety gave the sales license to GC Pharma for Glargia Prefilled Pen, which will be an import version of Lantus biosimilar by Indias Biocon. Sanofis Lantus is a blockbuster antidiabetic injection in the insulin market, selling more than 30 billion won ($282 million) in 2017, according to UBIST data. Glarzia will now compete against Basaglar, another long-acting insulin biosimilar from Eli Lilly and Boehringer Ingelheim thats sold by Eli Lilly. Basaglar was launched last April at a 14 percent discount of the original drug. It recorded some 300 million won (US$282,000) in sales last year, read reports. To fend off the growing biosimilar competition, Sanofi launched Toujeo, its own longer-acting basal insulin.Lantus currently dominates the Korean insulin injection market, which is estimated to be worth around 40 billion won. Continue reading >>

Biosimilars Are Beginning To Bite For Sanofi

Biosimilars Are Beginning To Bite For Sanofi

Biosimilars are beginning to bite for Sanofi French drugmaker Sanofi reported higher-than-expected sales growth of 5.5% in the second quarter versus the same period a year prior, boosted by double-digit jumps in revenues from its Genzyme unit and vaccines business. Sales from its diabetes and cardiovascular business, however, fell by 15% due to biosimilar competition in Europe and formulary exclusions in the U.S. Sanofirecently launched Dupixent(dupilumab) and Kevzara (sarilumab), two immunology drugs it expects to be a cornerstone of future growth. While Dupixent only brought in sales of 26 million, Sanofi noted that over 5,100 physicians had prescribed Dupixentas of July 26. While overall sales might be up, steepening declines from its diabetes and cardiovascular business continues to weigh on the drugmaker. Sales of insulin glargine (Lantus and Toujeo) were down 23.9% in the U.S., following the exclusion of Lantus from both CVS' and United Health's formularies. The launch of Eli Lilly's Lantus biosimilar Basaglar in the U.S. last December has also had an impact, albeit small. Merck & Co.'s Lusduna Nexvue , while currently on hold under the Hatch-Waxman Act, could pose a future threat. "We expect the sales decline to accelerate in the second half of 2017," said Sanofi CEO Olivier Brandicourt. "We will provide an update on the U.S. payer coverage in 2018 with the third quarter 2017 results." Lovenox (enoxaparin) sales fell in the quarter by 2.4% overall, with a 7.3% fall in Europe also driven by the launch of a biosimilar. "There has been one biosimilar to enoxaparin launched so far, and we expect that some others will be approved," said Brandicourt. "We have a high market share, and it is a competitive market. We see the biosimilars are just additional competitors, a Continue reading >>

Mylan And Biocon's Biosimilar Insulin Glargine Authorized In European Union And Australia

Mylan And Biocon's Biosimilar Insulin Glargine Authorized In European Union And Australia

Mylan and Biocon's Biosimilar Insulin Glargine Authorized in European Union and Australia The biosimilar insulin will be sold under the brand name Semglee in a 100 IU/mL 3mL prefilled pen presentation in both territories. Mylan and Biocon say that they plans to launch the product in various markets in Europe in the second half of 2018, and in Australia later this year. Mylan and Biocon have announced that their co-developed insulin glargine biosimilar, referencing Lantus, has been authorized for marketing by both the European Commission (EC), following a previous positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in January 2018 , as well as by the Therapeutic Goods Administration of Australia. The biosimilar insulin will be sold under the brand name Semglee in a 100 IU/mL 3mL prefilled pen presentation in both territories. The partnership says that it plans to launch the product in various markets in Europe in the second half of 2018, and in Australia later this year. This is the first product from Mylan and Biocons joint portfolio to receive a marketing authorization in Europe, and Biocons CEO and joint managing director, Arun Chandavarkar, PhD, called the 2 approvals important milestones in its work with Mylan. The partnership has also submitted the product for approval in the United States, though the drug will, if approved, follow the approval pathway for new drugs, not biosimilars; in the United States, insulins are currently regulated as drugs and not as biologics, and follow-on product sponsors must therefore submit New Drug Applications (NDAs), rather than Biologics License Applications, for these drugs. In addition to being subject to a different approval path in the United States, Semglee also faces unique legal obstacles along t Continue reading >>

Msds Lantus Biosimilar Given Conditional Fda Approval

Msds Lantus Biosimilar Given Conditional Fda Approval

MSDs Lantus biosimilar given conditional FDA approval MSD, known as Merck in North America, has been granted approval for its biosimilar of Sanofis diabetes treatment, Lantus. Potentially, this could see MSDs product take a slice of the $6.6 billion in sales that Lantus achieved in 2016. However, there is a hitch to the good news for MSD, it is dependent upon a patent infringement lawsuit brought against them by Sanofi. Under the Hatch-Waxman Act, the case means that there is currently a 30 months hold placed on the product reaching market until a decision one way or the other by a court. This is why the approval is conditional, as the resolution of the lawsuit in MSDs favour could allow them to bring its biosimilar to market immediately. MSDs product would not be the first biosimilar to enter the market as competition to the originator, with Eli Lilly and Boehringer Ingelheims Basalgar already entering the market. MSDs will be hoping to avoid the outcome of the patent result in this case, as the two companies were forced to pay a percentage of royalties on sales. Basalgar entered the market at a discount of 15%, managing sales of $86.1 last year but, as the product was approved in December 2016, it had little time to make an impact. The product itself is an insulin glargine injection, a long-lasting version of human insulin, and will be marketed under the brand name Lusduna Nexvue. The tentative approval of Lusduna Nexvue is an important milestone, bringing us closer to offering this medicine to patients, said Sam Engel, Associate Vice President of Merck Clinical Research. For Sanofi, the approval further challenges the sales of a product that generates approximately a sixth of its total sales. The company has acted proactively to counter the threat though, already re Continue reading >>

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