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Lantus Biosimilar

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www.mednutrition.gr During the 4th COMBO Endocrinology International Course which took place at 6-8 of October 2016, Mr Nikolaos Tentolouris, Associate Professor, Medical School, presented the biosimilar and new mixture of 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 Her Continue reading >>

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  1. Gaua

    diabetic husband mood swings

    Hi ! I am new to this but ... my husband is diabetic and has severe mood swings and it's getting overwhelming . I feel so lonely because he spends so much time alone. We have been married 43 years . I would say this moods just started about year ago and getting worse. Would love to know if anyone else is dealing with this? Thanks!

  2. AnnC

    Hello and welcome to DD. I'm sorry to hear that your husband is having mood swings; it must make your life a misery at times.
    How well is he controlling his diabetes? The mood swings might not be connected, but if his control is getting worse, then it could be part of the cause at least. Is there any way you can talk to him about it, or get him to seek help from his doctor?

  3. Seagal

    Welcome to the forum.
    Is your husband type 1 or type 2? Is he having trouble controlling his b.g. and/or any illnesses?
    I've been married 60 years and get moody sometimes and it isn't always related to diabetes

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4th JPEF Annual Global Diabetes Convention 2016 at Taj Vivanta, Trivandrum. Topic: Biosimilar Insulin: Made in India for the World Chair Person: Dr.Radhakrishnan A. P Speaker: Dr.Mathew John www.jothydev.net http://jothydev.net/jpef/Annualconven...

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 biologica Continue reading >>

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  1. Mom and boys

    Awareness Ribbons

    Just wondering if diabetes has a specific color for awareness ribbons(like breast cancer is PINK?

  2. Amy Tenderich

    Oh my, People: I'm glad you asked!!
    The international symbol for diabetes is the Blue Circle, which now appears at the top of this page in connection with World Diabetes Day.
    To read about the Blue Circle, what it means, and where you can get logos and pins, click on this link:
    http://www.diabetesmine.com/2008/11/why-the-blue-circle.html
    You can purchase lapel pins here:
    http://shop.idf.org/catalog/product_info.php?products_id=63

  3. London

    A blue circle or grey ribbon w/ a blood droplet inside the ribbon.

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Kiran Mazumdar- Shaw speaking on Biocons landmark achievement of receiving Regulatory Approval for its first Insulin Glargine from PMDA, MHLW in Japan. Proud moment for Biocon, Endorsement of our Capability in Biosimilars and Commitment to Quality. First Biosimilar From India to be approved in Japan. Prefilled Pen to be launched in Q1 FY17.

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 CH Continue reading >>

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Popular Questions

  1. Steve Rapaport

    Time of taking insulin always matters, though with a very slow-acting insulin like Lantus, ideally it matters less.
    As you can see here, insulin is most effective (peak) a few hours after you inject it. It then fades gradually over the next (duration) hours.
    Lantus (shown on this chart as glargine), has an average peak of about 5 hours, and a duration of about 24.
    You'll also notice that for the last 3 hours and the first 3 hours, it's not doing very much at all.
    All of these numbers are averages. They vary between individuals and also from day to day. You can measure these things yourself (and see how it works in you) by using your glucometer, keeping your carbohydrate intake to zero for the day (since carbohydrates cause a blood sugar peak), and then plotting your blood sugar over the course of a day on a graph, checking regularly at least once every two or three hours. That's called a 'curve'.
    Important: the curves shown here are 'insulin action', going up when the insulin is most effective. You can't measure this directly. Your curve will be 'blood glucose' and will be roughly the opposite -- it will go DOWN when the insulin is most effective, and up when it starts to wear off.
    If your Lantus curves roughly match the peak and duration shown here, you can plan the six-hour lull (between hours 21 and 24, then 0 to 3) to be when you're not eating or moving (likely when you're asleep). So a morning shot is probably ideal. Depending when you have breakfast, a shot three hours before you wake up might be even better. Ideally you want the 5-hour 'peak' action to happen when you most need it, like an hour after you eat.
    If your curves are radically different, though, you might find a better choice of shot time to match your own eat/sleep times.

  2. Carol Linn Miller

    Yes, it DOES make a difference, and it is different FOR EVERY diabetic. i accidentally took 5 units of Levemir at lunch earlier today, so i should NOT take another 5 units of Levemir at at dinner, but i SHOULD and will be taking Novolog, which is fast acting AS USUAL WHICH insulin works best for each diabetic is something you work out along with your doctor. It took several months to work out the ratio of how may grams of carbohydrate for EACH unit of insulin works for me, AND , since i've been sliding scale almost my ENTIRE life, I CAN and do adjust that DAILY. I may not a be a healthcare professional, but once my mother stopped determining how much insulin I was taking because I stopped asking her, That means i have DECADES of personal life experience, NOW ^ AND COUNTING, which should give me SOME online credibility, because i am STILL ALIVE AND KICKING. LOL! Sometime painfully kicking because of arthritis.

  3. Ben Bacon

    Not if you adjust for the action curve of the insulin. Lantus has a slight peak in 5 hrs or so, not much. But if you tend to be low in the morning anyway, don’t take Lantus before bed, take it in the a.m. I take it before bed and I have had a few lows in the morning and my sugars tend to rise in the p.m. so I try to adjust meals and use fast acting to compensate for that.

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