Endocrinology

Insulin maker Novo Nordisk has announced that, in January of 2020, it will launch authorized generics of its NovoLog (insulin aspart) and NovoLog Mix (insulin aspart protamine and insulin aspart) products. Notably, the authorized generics will become available before the March 2020 transition of insulins to regulation as biologics and biosimilars rather than drugs and generics.
Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second Complete Response Letter (CRL) for their follow-on insulin glargine product referencing Lantus.
 
Women are more likely than men not to take their diabetes medication as prescribed in an effort to control prescription drug costs, as are adults under age 65, according to a report published this month by the Centers for Disease Control and Prevention (CDC).
 
While drug makers who sell insulin in the United States have had the past decade to prepare for the transition, stakeholders within the diabetes community must grapple with the potential impacts that this regulatory change could have.
Winnie Tiedemann, 73, of New Jersey lives with her son and his 5 children. Tiedemann was diagnosed with diabetes at age 25 and has been insulin-dependent for the past 20 or so years. Her out of pocket costs for insulin? Around $3600 a year.
Sandoz announced today that it has enrolled its first patient in a combined phase 1 and phase 3 study of its proposed denosumab biosimilar versus EU-authorized Prolia.
A study published in The New England Journal of Medicine examining rituximab in membranous nephropathy found that it is noninferior to cyclosporine in inducing proteinuria remission at 12 months and is superior to maintaining long-term remission up to 24 months in patients at high risk for progressive disease.
A worldwide survey conducted by an international type 1 diabetes (T1D) advocacy non-profit found that rationing of insulin and related supplies was the greatest in the Unites States.
 
Insulin maker Sanofi is currently developing a proposed biosimilar of insulin aspart (NovoLog), made by Novo Nordisk. In 3 late-breaking poster presentations at the American Diabetes Association (ADA) 79th Scientific Sessions, held June 7-11, 2019, in San Francisco, California, researchers presented data on the biosimilar, SAR341402.
Generic drug maker Lannett Company has announced the beginning of a clinical trial of its proposed biosimilar insulin glargine referencing Lantus.

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