Diabetes

Eye on Pharma: Pfenex Reports Results of Human Factors Study for Follow-on Teriparatide

October 19th 2019

By The Center for Biosimilars Staff

Article

Drug maker Pfenex announced this week that it has completed its comparative use human factors study for its follow-on teriparatide product, PF708, referencing the osteoporosis drug Forteo.

Novo Nordisk Plans Authorized Generic Insulins for Early 2020

September 12th 2019

By The Center for Biosimilars Staff

Article

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.

Mylan and Biocon Get a Second CRL for Insulin Glargine Follow-on

September 3rd 2019

By Kelly Davio

Article

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 More Likely Than Men to Ration Diabetes Meds Due to Cost, CDC Says

August 27th 2019

By Allison Inserro

Article

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).

How Prepared Is the United States for the Transition of Insulins to Regulation as Biologics?

August 20th 2019

By Kelly Davio

Article

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.

Patients Say They Are Ready for Cost-Saving Biosimilar Insulin

August 10th 2019

By Sara Karlovitch

Article

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 Enrolls First Patient in Study of Proposed Denosumab Biosimilar, GP2411

July 22nd 2019

By Kelly Davio

Article

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.

Study Finds Rituximab Noninferior to Cyclosporine for Membranous Nephropathy

July 4th 2019

By Allison Inserro

Article

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.

Insulin Rationing Is a Global Problem, But at Its Worst in the United States

June 19th 2019

By Allison Inserro

Article

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.

At ADA, Sanofi Reveals Data on Proposed Insulin Aspart Biosimilar, SAR341402

June 10th 2019

By Kelly Davio

Article

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.