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Humalog Biosimilar

Sanofi Receives Tentative Fda Approval Of Admelog (insulin Lispro Injection) 100 Units/ml - Sep 1, 2017

Sanofi Receives Tentative Fda Approval Of Admelog (insulin Lispro Injection) 100 Units/ml - Sep 1, 2017

Sanofi Receives Tentative FDA Approval of Admelog (insulin lispro injection) 100 Units/mL BRIDGEWATER, N.J., Sept. 1, 2017 / PRNewswire-USNewswire / -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog. Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus. The tentative approval is based on physicochemical, non-clinical and clinical similarity to another insulin lispro 100 Units/mL as currently approved in the U.S., including data from a clinical development program involving more than 1,000 adults living with type 1 or type 2 diabetes. Admelog is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of its other ingredients. With the tentative approval, the FDA concluded that Admelog met all necessary regulatory requirements for approval in the U.S., pending any patent issues that are yet to be resolved. "Sanofi is committed to broadening our portfolio of products to help people living with diabetes manage their blood sugar," said Stefan Oelrich, Senior Vice President and Head, Global Diabetes Franchise, Sanofi. "With this tentative approval, we are now one step closer to offering Admelog as an option for those who use rapid-acting insulin." The trade name "Admelog" was granted provisional approval by the FDA and will be used in the U.S. when the product is made available. Admelog was also granted marketing authorization under the proprietary name, Insulin lispro Sanofi, by the European Commission in July 2017. Diabetes and cardiovascular disease affect millions of people worldwide, with many managing the complex challenges of both. Bu Continue reading >>

Biosimilar Of Humalog Shows Non-inferiority In Type 1 Diabetes Lauren Santye, Assistant Editor Publish Date: Monday, August 21, 2017

Biosimilar Of Humalog Shows Non-inferiority In Type 1 Diabetes Lauren Santye, Assistant Editor Publish Date: Monday, August 21, 2017

Biosimilar of Humalog Shows Non-Inferiority in Type 1 Diabetes A biosimilar of Humalog (insulin lispro; Ly-Lis) was found to be comparable to the brand name drug, according to a study published in Diabetes Technology & Therapeutics. The randomized, open-label phase 3 SORELLA 1 trial aimed to demonstrate similar safety, efficacy, and immunogenicity of SAR342434 (SAR-Lis) versus Ly-Lis in adult patients with type 1 diabetes treated with multiple daily injections while using Lantus. Ly-Lis is a fast-acting human insulin analog used to lower blood glucose. It is usually injected within 15 minutes before a meal or immediately after. A total of 507 patients were included in the study, completing the 6-month trial and continuing with SAR-Lis or Ly-Lis in a randomized 6-month extension. The investigators evaluated changes in HbA1c, fasting plasma glucose, 7-point self-monitored plasma glucose profiles, hypoglycemic events, treatment-emergent adverse events (AEs), and anti-insulin antibodies. The results of the study showed the least square mean change in HbA1c was similar in both treatment groups. Non-inferiority at prespecified 0.3% non-inferiority margin and inverse non-inferiority was demonstrated, according to the report. A small increase in HbA1c was observed in both groups at week 52 versus week 26. Similarities in fasting plasma glucose and 7-point self-monitored plasma glucose profiles were observed between groups. The investigators also observed similar changes in mean daily mealtime and basal insulin doses at week 52. No difference in hypoglycemia, treatment-emergent AEs, and anti-insulin antibodies were observed. The most common AEs were hypersensitivity events and injection site reactions. Limitations to the study included the populationwhich was largely adult whit Continue reading >>

Sanofis Franchise Defense Sees Biosimilar Insulin Lispro Under Eu Review

Sanofis Franchise Defense Sees Biosimilar Insulin Lispro Under Eu Review

Sanofis Franchise Defense Sees Biosimilar Insulin Lispro Under EU Review Ian Schofield @ScripIanS [email protected] Sanofi has filed a biosimilar version of Lillys antidiabetic Humalog with the EUs CHMP, and received the all-clear for a new combination of Lantus and lixisenatide, as it tries to address difficulties in its diabetes franchise. The European Medicines Agencys scientific committee, the CHMP, has begun evaluating Sanofi s SAR342434, a biosimilar version of Eli Lilly & Co. s diabetes drug Humalog (insulin lispro). The product was accepted for review in September this year following the completion of two Phase III trials, SORELLA 1 and SORELLA 2. The biosimilar is seen as part of Sanofis effort to address its difficulties in the diabetes area as sales of Lantus (insulin glargine) continue to decline in the face of competition. The company is also putting its money on sales of Toujeo, a new formulation of Lantus, as well as a combination of Lantus and the new drug lixisenatide that has just received the OK from the CHMP. The SORELLA 1 trial involved 507 patients with Type I diabetes from the US, Europe and Japan who were also using insulin glargine, and was aimed at assessing safety and efficacy of SAR342434 and its non-inferiority versus Humalog. Interim six-month results presented at the American Diabetes Association meeting in June this year showed the Sanofi drug to be as effective and well tolerated as Humalog. No differences were observed in the percentage of patients reporting hypoglycemia and a similar percentage of patients developed anti-insulin antibodies in both groups, according to a report in Practice Update. SORELLA 2 was a six-month, randomized, open-label, parallel-group comparison of SAR342434 and Humalog in adults with Type 2 diabetes Continue reading >>

Anti-insulin Antibodies And Adverse Events With Biosimilar Insulin Lispro Compared With Humalog Insulin Lispro In People With Diabetes.

Anti-insulin Antibodies And Adverse Events With Biosimilar Insulin Lispro Compared With Humalog Insulin Lispro In People With Diabetes.

Diabetes Technol Ther. 2018 Feb;20(2):160-170. doi: 10.1089/dia.2017.0373. Anti-Insulin Antibodies and Adverse Events with Biosimilar Insulin Lispro Compared with Humalog Insulin Lispro in People with Diabetes. 1 Institute for Cellular Medicine, Newcastle University , Newcastle upon Tyne, United Kingdom . 2 Institut fr Klinische Forschung und Entwicklung (IKFE) , Berlin, Germany . 3 Sanofi-Aventis Deutschland, Frankfurt, Germany . 5 Barbara Davis Center for Diabetes, University of Colorado Denver , Aurora, Colorado. SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (Humalog; Ly-Lis). Two randomized, controlled, open-label, parallel-group, phase 3 studies were conducted to compare the efficacy and safety of SAR-Lis and Ly-Lis, both in combination with insulin glargine (Lantus). SORELLA 1 was a 12-month study in 507 people with type 1 diabetes mellitus (T1DM); SORELLA 2 was a 6-month study in 505 people with type 2 diabetes mellitus (T2DM). In this study, the impact of anti-insulin antibodies (AIA) to SAR-Lis and Ly-Lis on safety and glycemic control is reported. AIA were measured regularly throughout both studies at a centralized laboratory blinded to treatment groups using a drug-specific AIA assay. The AIA status (positive or negative), AIA titers, and cross-reactivity to human insulin, insulin glargine, and insulin glargine metabolite M1 were analyzed. The potential effect of AIA on safety, particularly as related to hypersensitivity reactions, hypoglycemia, and treatment-emergent adverse events, as well as on glycemic control (HbA1c, insulin dose), was evaluated. AIA positive status at baseline was similar for the two insulins, but higher in T1DM than in T2DM. In both studies, the percentage of people newly developing AIA in the two treatment groups, Continue reading >>

Why Is Humalog Expensive? And How Can You Save?

Why Is Humalog Expensive? And How Can You Save?

Why is Humalog Expensive? And How Can You Save? Tori Marsh, MPH, is on the Research Team at GoodRx, and is the resident expert on drug pricing and savings. Humalog (insulinlispro) is a fast-acting insulin used to treat diabetes type one and two. Doctors report low levels of adherence to insulins like Humalog because of its cost. Cash prices for Humalog average around $549 for five kwikpens, and there is no generic alternative for any insulin brand. Humalog generated billions of dollars in global sales for Eli Lilly in 2016. Here is some information on Humalog, and how you can save. Typically, when a manufacturer releases a brand name drug, it is protected by a patent. This means that the manufacturer holds market exclusivity for that drug, preventing other manufacturers from creating an alternative. The idea is to incentivize companies to innovate (such as spending money researching new drugs) with a period when they can reap the rewards for their work. Eventually, though, the patent expires, allowing competitors to create their own versions with the same active ingredient. These are known as generics. In the case of Humalog, the patent expired in 2015, but no generic is on the market yet, and we may never see one. The reason has to do with the difference between drugs made of chemical formulations (think of any ordinary pill), and those treatments made from living, biologic organisms such as insulin. Humalogs biosimilar follow-on, Admelog , was approved last year but is not yet available in pharmacies. Stay tuned, we will keep you updated. Get the best ways to save on your prescriptions delivered to your inbox. By signing up, I agree to GoodRx's terms of service and privacy policy . The cash price for insulins can range anywhere from $120 to $600 a month. At the momen Continue reading >>

Sanofi Wins Tentative Fda Approval For Humalog Biosim, Putting Billions In Lilly Sales At Risk

Sanofi Wins Tentative Fda Approval For Humalog Biosim, Putting Billions In Lilly Sales At Risk

Eli Lilly has faced no shortage of trouble in diabetes recently, but the company now faces a new threat from rival Sanofi. The latter company won tentative FDA approval for a biosimilar to Lilly’s Humalog, putting billions in insulin sales at risk for the Indianapolis drugmaker. Sanofi won provisional approval for its biosim Admelog on Sept. 1, according to an FDA letter. Also a top player in diabetes, the French drugmaker now has 45 days to notify Lilly of the news, Bernstein analyst Tim Anderson wrote in a note to clients. Humalog was Eli Lilly’s top seller last year, bringing in $2.76 billion around the world; what the drugmaker does in response to the Sanofi approval could change the potential launch timeline for the biosim, Anderson continued. Humalog itself is out of patent protections, but Lilly could win up to 2.5 years of additional exclusivity if it chooses to sue for infringement on its remaining patent covering the KwikPen injection device, the analyst noted. The risk, however, is that it could run into trouble for filing a frivolous lawsuit. The risk if it doesn't is that Sanofi might launch much sooner. Alternatively, the parties could settle on a “mutually agreeable” launch date, Anderson wrote. RELATED: Lilly to cut 3,500 jobs, take a $1.2B hit as it aims for $500M in savings That patent issue aside, on Thursday, Lilly announced a significant round of job cuts—3,500—as it looks to save $500 million in annual expenses. The drugmaker will take a $1.2 billion hit to pay for site closures plus severance and retirement expenses. The cuts amount to more than 8% of the company’s global workforce. Marking new CEO David Ricks’ first major overhaul of the company, Thursday’s round of cuts come as Lilly struggles in diabetes due to increasing pres Continue reading >>

Sanofi Receives Tentative Fda Approval For Insulin Lispro Biosimilar Posted 15/09/2017

Sanofi Receives Tentative Fda Approval For Insulin Lispro Biosimilar Posted 15/09/2017

Home / Biosimilars / News / Sanofi receives tentative FDA approval for insulin lispro biosimilar Sanofi receives tentative FDA approval for insulin lispro biosimilar Posted 15/09/2017 Pharma giant Sanofi announced on 1 September 2017 that it had received tentative approval for Admelog, its insulin lispro biosimilar, from the US Food and Drug Administration (FDA). Insulin lispro is a fast acting insulin analogue used to treat people living with type 1 or type 2 diabetes. Insulin lispro has one primary advantage over regular insulin for postprandial glucose control. It has a shortened delay of onset, allowing slightly more flexibility than regular insulin, which requires a longer waiting period before starting a meal after injection. Both types should be used in combination with a longer acting insulin for good glycaemic control. Admelog is a proposed biosimilar to Eli Lillys Humalog (insulin lispro), which had worldwide sales of US$2.8 billion in 2016. Humalog no longer has effective exclusivity through patent protection or data protection in either Europe or the US [1]. The tentative approval is based on physicochemical, non-clinical and clinical similarity to another insulin lispro 100 units/mL as currently approved in the US, including data from a clinical development programme involving more than 1,000 adults living with type 1 or type 2 diabetes. Admelog is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of its other ingredients. With the tentative approval, FDA concluded that Admelog met all necessary regulatory requirements for approval in the US, pending any patent issues that are yet to be resolved. Sanofi started phase I clinical development for both insulin lispro and insulin aspart biosimilars ba Continue reading >>

Fda Approves Sanofi's Admelog® (insulin Lispro Injection)

Fda Approves Sanofi's Admelog® (insulin Lispro Injection)

Press Release Source: Sanofi (EURONEXT: SAN) (NYSE: SNY) FDA Approves Sanofi's Admelog® (insulin lispro injection) First FDA-approved follow-on mealtime insulin Admelog (insulin lispro injection) 100 Units/mL will be available in U.S. in vial and SoloStar pen Paris, France - December 11, 2017 - The U.S. Food and Drug Administration (FDA) has approved Sanofi's Admelog®, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. "Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes. Complementing our existing insulin portfolio, Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime," said Stefan Oelrich, Executive Vice President and Head, Global Diabetes and Cardiovascular, Sanofi. "The approval of Admelog is an important milestone for Sanofi in our mission to serve patients living with chronic diseases such as diabetes." Admelog is a rapid-acting insulin similar to Humalog®, another insulin lispro 100 Units/mL, currently approved in the U.S. The Admelog clinical development program involved more than 1,000 adults living with type 1 or type 2 diabetes. Admelog will be available in both vials and the SoloStar pen, which is the most-used disposable insulin pen platform in the U.S. Admelog was also granted marketing authorization as a biosimilar, under the proprietary name, Insulin lispro Sanofi®, by the European Commission in July 2017. What is Admelog (insulin lispro injection)? Prescription Admelog is a fast-acting human insulin used to improve blood sugar control in adults with Type 2 diabetes and adults and children (3 years and older) with Type 1 diabetes. About Sanofi Sanofi is dedicated to supporting peop Continue reading >>

Payback Time Nears As Sanofi Gets Chmp Backing For Biosimilar Humalog

Payback Time Nears As Sanofi Gets Chmp Backing For Biosimilar Humalog

Payback time nears as Sanofi gets CHMP backing for biosimilar Humalog Panel recommends insulin Lispro Sanofi to treat diabetes Sanofi's biosimilar version of Eli Lilly's mealtime insulin product Humalog has been recommended for approval in the EU, raising the prospect of further pressure on Lilly's top-selling product. The Committee for Medicinal Products for Human Use (CHMP) gave the go-ahead for Sanofi's version of insulin lispro - the active ingredient in Humalog - as well as three other biosimilars at its monthly meeting late last week. The recommendation is sweet for Sanofi giving it an opportunity to turn the tables on Lilly, which recently bagged approval for its biosimilar of Sanofi's long-acting insulin blockbuster Lantus (insulin glargine) in Europe and the US. The panel recommended the use of the biosimilar - called insulin lispro Sanofi - to treat adults and children who have diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed. The French drugmaker said it was its "first major regulatory milestone for a biosimilar diabetes treatment". The importance of Humalog to Lilly cannot be overstated particularly as biosimilar competition is looking on most major markets between now and 2019. The drug brought in $2.8bn last year, a small decline on 2015 but bounced back in the first quarter of 2017 with sales of $708m, substantially ahead of analyst expectations. Lilly had sought to protect its franchise by developing a new formulation of Humalog using a protein delivery technology owned by Adocia but abandoned the project and terminated its partnership earlier this year. Meanwhile among other positive opinions granted by the CHMP was one for Leo Pharma's interleukin-17 inhibitor Kyntheu Continue reading >>

Fda Approves Sanofi's Admelog® (insulin Lispro Injection)

Fda Approves Sanofi's Admelog® (insulin Lispro Injection)

PARIS, Dec. 11, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Sanofi's Admelog®, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. "Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes. Complementing our existing insulin portfolio, Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime," said Stefan Oelrich, Executive Vice President and Head, Global Diabetes and Cardiovascular, Sanofi. "The approval of Admelog is an important milestone for Sanofi in our mission to serve patients living with chronic diseases such as diabetes." Admelog is a rapid-acting insulin similar to Humalog®, another insulin lispro 100 Units/mL, currently approved in the U.S. The Admelog clinical development program involved more than 1,000 adults living with type 1 or type 2 diabetes. Admelog will be available in both vials and the SoloStar pen, which is the most-used disposable insulin pen platform in the U.S. Admelog was also granted marketing authorization as a biosimilar, under the proprietary name, Insulin lispro Sanofi®, by the European Commission in July 2017. What is Admelog (insulin lispro injection)? Prescription Admelog is a fast-acting human insulin used to improve blood sugar control in adults with Type 2 diabetes and adults and children (3 years and older) with Type 1 diabetes. Important Safety Information for Admelog (insulin lispro injection) Do not use Admelog if you have low blood sugar or if you are allergic to insulin lispro or any of the other ingredients in Admelog. Before starting Admelog, tell your doctor about all your medical conditions, including if you have liver or kid Continue reading >>

Biosimilars Of Insulin Lispro Posted 18/08/2017

Biosimilars Of Insulin Lispro Posted 18/08/2017

Last update: 18 August 2017 Insulin glargine is a fast acting insulin analogue used to treat people living with Type 1 or Type 2 diabetes. Insulin lispro has one primary advantage over regular insulin for postprandial glucose control. It has a shortened delay of onset, allowing slightly more flexibility than regular insulin, which requires a longer waiting period before starting a meal after injection. Both types should be used in combination with a longer acting insulin for good glycaemic control. The originator product, Eli Lilly’s Humalog (insulin lispro), was approved by the US Food and Drug Administration (FDA) in June 1996 and by the European Medicines Agency (EMA) in April 1996 [1]. Humalog generated an estimated US$2.8 billion in net sales income globally for Eli Lilly in 2016. Humalog no longer has effective exclusivity through patent protection or data protection in either Europe or the US. Some of the insulin lispro biosimilars and non-originator biologicals approved or in development are presented in Table 1. Table 1: Biosimilars and non-originator biologicals* of insulin lispro approved or in development Company name, Country Product name Stage of development Biocon/Mylan, India*/USA - ‘Similar biologic’ currently under preclinical/ scale-up development Sanofi, USA Insulin lispro Sanofi Approved by EMA in May 2017 [1] EMA: European Medicines Agency. *See editor’s comment Sanofi’s insulin lispro biosimilar was approved by EMA’s Committee for Medicinal Products for Human Use on 19 May 2017 [1]. Generics giant Mylan and India-based Biocon have made an agreement to develop and market Biocon’s biosimilar versions of three insulin analogue products, which include Lantus, as well as Eli Lilly’s Humalog (insulin lispro) and Novo Nordisk’s NovoLog Continue reading >>

Sanofi Turns The Tables On Lilly With Biosimilar Fast-acting Insulin

Sanofi Turns The Tables On Lilly With Biosimilar Fast-acting Insulin

Eli Lilly’s big-selling insulin, Humalog, faces cut-price competition after the US regulator approved a biosimilar from Sanofi. Sanofi’s Admelog (insulin lispro) is approved in type 1 and type 2 diabetes as a follow-on drug to Humalog, a rapid-acting insulin that is Lilly’s top selling drug, bringing in almost $700 million in Q3 alone. The use of the older “follow-on” route to approve the biosimilar represents yet another way in which the FDA’s new commissioner Scott Gottlieb is looking to accelerate decision-making in order to generate greater competition and drive down prices – a goal which was previously considered outside the FDA’s remit. US sales of Humalog in Q3 were nearly $415 million, an increase of 10% compared with last year’s Q3, driven more by increased prices, and to a lesser extent by increased volume. But it looks unlikely that Lilly will be able to maintain this with the launch of Humalog, which is available in vial form or as a disposable pen. Sanofi fights back This represents Sanofi’s first foray into the biosimilar diabetes market, and has been persuaded to join the fray as its own portfolio takes a beating from cheaper copies. With Admelog Sanofi hopes to to turn the tables on Eli Lilly – in partnership with Boehringer Ingelheim the US pharma has stolen market share in the longer-acting insulin market with a cheaper version of Sanofi’s Lantus (insulin glargine). Approved at the beginning of 2016, US revenues of the cheaper competitor, Basaglar, were around $115 million in Q3, almost double the previous quarter thanks to a strong launch. Lantus sales are dropping fast because of the competition, and in its Q3 results Sanofi said US revenues from Lantus were down 15.5% in the quarter to $1.123 billion. Admelog has also been ap Continue reading >>

Sanofi Wins Fda Approval For Biosimilar Of Lilly's Humalog

Sanofi Wins Fda Approval For Biosimilar Of Lilly's Humalog

Sanofi Wins FDA Approval for Biosimilar of Lilly's Humalog December 12, 2017, 09:21:00 AM EDT By Zacks Equity Research, Zacks.com Sanofi SNY received FDA approval for Admelog, its biosimilar version of Eli Lilly & Company's LLY blockbuster rapid-acting insulin, Humalog (insulin lispro). Admelog is technically a follow-on biologic version of Humalog, which recorded sales of $2.08 billion in 2017 so far. Admelog is the first follow-on Humalog product to be approved by the FDA to help adult patients with type II diabetes and children (3 years and older) with type I diabetesmanage their blood sugar levels at mealtime. Admelog (100 Units/mL) will be available in the United States in vial and SoloStar pen. Please note that Admelog received marketing approval in the EU in July this year. Sanofi's shares have risen 8% so far this year, comparing unfavorably with a gain of 15.6% recorded by the industry . Sanofi's Diabetes franchise is under significant pressure with key product, Lantus, facing increasing competitive pressure at the payor level and biosimilar competition in several European markets and Japan. Moreover, a follow-on product to Lantus hit the market in the form of Lilly and Boehringer Ingelheim's, Basaglar in mid-December 2016. In 2017 so far, Lantus sales have declined 24.9% in the United States due to lower average net price and exclusion from the CVS Health Corporation CVS and United Health formulary plans. U.S. diabetes sales have declined 20.2% so far in 2017. In fact, U.S. diabetes franchise sales are expected to decline at an accelerated rate in the fourth quarter due to CVS/United Health formulary exclusion plans, continued lower average pricing and difficult comparisons with the last year. Please note that once you make your selection, it will apply to al Continue reading >>

Fda Approves Humalog Biosimilar

Fda Approves Humalog Biosimilar

Post by mnholdem on Dec 12, 2017 9:03:45 GMT -5 FDA Approves Sanofi's Admelog (insulin lispro injection) * First FDA-approved follow-on mealtime insulin * Admelog (insulin lispro injection) 100 Units/mL will be available in U.S. in vial and SoloStar pen PARIS, Dec. 11, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Sanofi's Admelog, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. "Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes. Complementing our existing insulin portfolio, Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime," said Stefan Oelrich, Executive Vice President and Head, Global Diabetes and Cardiovascular, Sanofi. "The approval of Admelog is an important milestone for Sanofi in our mission to serve patients living with chronic diseases such as diabetes." Admelog is a rapid-acting insulin similar to Humalog, another insulin lispro 100 Units/mL, currently approved in the U.S. The Admelog clinical development program involved more than 1,000 adults living with type 1 or type 2 diabetes. Admelog will be available in both vials and the SoloStar pen, which is the most-used disposable insulin pen platform in the U.S. Admelog was also granted marketing authorization as a biosimilar, under the proprietary name, Insulin lispro Sanofi, by the European Commission in July 2017. Source: www.biospace.com/article/releases/fda-approves-sanofi-s-admelog-the-first-follow-on-insulin-to-control-sugar-at-mealtime/ MnHoldem's Comment: There's been no indication yetwhat the price of Sanofi's biosimilar insulin lispro will be, but I imaginethat Sanofiwill have little problem Continue reading >>

Fda Grants Tentative Approval To Follow-on Insulin Lispro, Admelog

Fda Grants Tentative Approval To Follow-on Insulin Lispro, Admelog

FDA Grants Tentative Approval to Follow-On Insulin Lispro, Admelog The FDA has grantedtentative approval of Sanofis follow-on insulin lispro injection, Admelog. Referenced on the originator product, Humalog, Sanofis insulin lispro is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes. The FDA has granted tentative approval of Sanofis follow-on insulin lispro injection, Admelog. Referenced on the originator product, Humalog, Sanofis insulin lispro is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes. "Sanofi is committed to broadening our portfolio of products to help people living with diabetes manage their blood sugar,"saidStefan Oelrich, senior vice president and head of the global diabetes franchise for Sanofi."With this tentative approval, we are now one step closer to offering Admelog as an option for those who use rapid-acting insulin." As was the case with Mercks recent tentative approval for its insulin glargine follow-on product, Lusduna, the FDA will not grant final authorization for Admelog until patent litigation has concluded. The drugs tentative approval is based on its similarity to its reference product, though in the United States, follow-on insulin products are not regulated as biosimilars. Because the FDA treats innovator insulins as drugs, rather than as biologic products, treatments such as Admelog are regulated as follow-ons. Thus, Sanofi will have to address any patent infringement claims under the Hatch-Waxman Act, which governs the generic drug approval process, rather than under the Biologics Price Competition and Innovation Act. In May, the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) ado Continue reading >>

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