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Biosimilars Coming To Diabetes Treatments: How, What, Where, And When?

Biosimilars Coming to Diabetes Treatments: How, What, Where, and When?

Biosimilars Coming to Diabetes Treatments: How, What, Where, and When?

Congress creates abbreviated licensure pathway for biological products similar to or interchangeable with FDA-approved products.
A biosimilar product is a biologic product that is approved based on demonstrating that it is highly similar to an FDA‐approved biologic product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.
Congress, through the Biologics Price Competition and Innovation Act (BPCI Act) of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. This pathway was established as a way to provide more treatment options, increase access to lifesaving medications, and potentially lower health care costs through competition.
FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product.
Prescription medications, especially those for chronic diseases like diabetes and cardiovascular disease have become a major economic burden. Due to rising diagnosis of type 1 and type 2 diabetes, it is understandable why more cost efficient biosimilar products are being developed. Diabetes biosimilar biologic products such as GLP-1 receptor agoni Continue reading

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Are Lifestyle Changes Better Than Diabetes Medications?

Are Lifestyle Changes Better Than Diabetes Medications?

Often, patients come to us feeling guilty about their food choices and lifestyle habits. Though guilt rarely is a helpful emotion, remorseful clients can be wonderful to work with when they’re ready to make significant lifestyle changes. But what should we do when clients with newly diagnosed type 2 diabetes are so motivated to reverse the course of their disease with diet and exercise that they refuse medications prescribed by their doctors? I know the power of lifestyle changes, and of course, I want to support my patients’ decisions. But I can’t agree with this choice. Here’s why.
While I truly appreciate the desire to avoid medications and their potential side effects, I know that time is of the essence. I understand what insulin resistance and type 2 diabetes do to the body, how the problem is progressive, how insulin resistance likely has occurred for years before the diabetes diagnosis, how it affects multiple systems in the body, harms the heart and blood vessels, and raises the risk for certain types of cancer.
My quick reply to the “What should I do?” question is to use every tool available. Don’t wait. Work toward permanent lifestyle changes now and take your medications now. Though there are possible side effects to taking medications, there also are side effects to not taking medications. People who successfully manage type 2 diabetes from the time of diagnosis are the ones most likely to have good outcomes years down the line.
I advise my clients to combine lifestyle changes and diabetes medications. Only when they’ve made solid lifestyle chang Continue reading

Innovative Products to Address the Unique Needs of Patients With Diabetes

Innovative Products to Address the Unique Needs of Patients With Diabetes

Sponsored by BD.
Patients with diabetes have unique needs—for example, they may take multiple medications, including insulin, and they may be at a higher risk for complications from illnesses, including vaccine-preventable diseases.1 By some estimates, patients with diabetes see a pharmacist 7 times more often than they see a physician; thus, pharmacists have additional opportunities to talk about the use of medications and other appropriate interventions (eg, vaccinations).2,3
Becton Dickinson (BD), a leader in diabetes innovation and care, was the first company to develop and commercialize disposable syringes and short-needle insulin syringes.4 Today, BD continues to address the unique needs of patients with diabetes by developing innovative technologies that improve injection comfort and convenience to help optimize patient outcomes. Over the past several years, BD has demonstrated the efficacy and safety of shorter needles and has introduced technologies that further improve both the comfort and ease of injection.5-8
BD INNOVATIONS TO ADDRESS UNMET NEEDS
Area for Improvement: Accidental Intramuscular Injection
Innovation: BD NanoTM Pen Needles
Use of BD Nano 4 mm pen needles rather than longer pen needles can significantly lower the risk of accidental intramuscular injection. Patients who use BD Nano 4 mm pen needles may be as much as 30 times less likely to accidentally inject medication intramuscularly than patients who use 8 mm needles.9 To optimize injection comfort, BD Nano 4 mm pen needles combine 2 technologies. First, the BD Nano pen needle has a PentaPoint co Continue reading

Drug for type 2 diabetes provides significant benefits to type 1 diabetic patients

Drug for type 2 diabetes provides significant benefits to type 1 diabetic patients

BUFFALO, N.Y. -- A majority of patients with Type 1 diabetes who were treated with dapagliflozin, a Type 2 diabetes medicine, had a significant decline in their blood sugar levels, according to a new study published in The Lancet Diabetes and Endocrinology. The results are being presented today by the University at Buffalo researcher who led the study at the annual meeting of the European Association for the Study of Diabetes in Lisbon.
Called DEPICT-1, which stands for Dapagliflozin in Patients with Inadequately Controlled Type 1 diabetes, the 24-week study was the first global multicenter investigation of dapagliflozin to test its efficacy and safety in Type 1 diabetes. The double-blind, randomized, three-arm, phase 3 multicenter study was conducted at 143 sites in 17 countries, including the U.S. It was funded by AstraZeneca and Bristol-Myers Squibb, the companies that partnered to develop dapagliflozin.
Participants were 833 patients aged 18-75 who had inadequately controlled blood sugars with a mean baseline hemoglobin A1C (HbA1c) -- a measure of sugar in the blood -- level of 8.53. A1C levels for Type 1 diabetics are considered optimal when they are under seven.
Adjunct to insulin
The results demonstrate that when this drug, a sodium glucose cotransporter-2 inhibitor (SGLT-2) was administered as an adjunct therapy in addition to the insulin that patients with Type 1 diabetes need to survive, it significantly improved outcomes.
"Our paper provides the initial signal that dapagliflozin is safe and effective in patients with Type 1 diabetes and is a promising adjunct tre Continue reading

Autism risk and maternal diabetes with obesity: What you need to know

Autism risk and maternal diabetes with obesity: What you need to know

Our experts provide perspective on new research linking diabetes and obesity during pregnancy with increased risk of autism
In today’s Pediatrics, researchers at Johns Hopkins Bloomberg School of Public Health report that they found a three- to four-fold higher rate of autism among children born to women who were both diabetic and obese during pregnancy.
The findings raise many questions and concerns. To provide perspective, we talked with epidemiologist Michael Rosanoff and developmental pediatrician Paul Wang. Dr. Wang is Autism Speaks’ senior vice president for medical research. Mr. Rosanoff is Autism Speaks’ director for public health research.
Q: Too often, this type of finding is taken as implying parents are somehow to blame for their children’s autism. Why would you urge against such an interpretation?
Michael Rosanoff: Autism is a complex condition caused by a combination of environmental and genetic factors. By environmental, researchers mean a broad range of nongenetic influences including maternal health and conditions in the womb. No one environmental factor causes autism by itself. So when we say an environmental factor increases the risk of autism, we are not saying that it causes autism. In other words, not all moms who are both diabetic and obese will have a child with autism. In fact, the vast majority will not.
Paul Wang: We welcome research that helps us identify some of the factors that increase the risk that autism will develop. But as Michael suggests, the vast majority of children exposed to these risk factors do not develop autism. Except in Continue reading

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