Endocrinology

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.
Eli Lilly and Company announced this week that it has made a lower-cost insulin lispro injection available in pharmacies. The company said that the authorized version carries a list price ($137.35 per vial and $265.20 for a package of 5 pens) that is 50% lower than that of the brand-name Humalog injection.
Set against a backdrop of rising concern about the cost of insulin, the FDA held a hearing about biosimilar insulins Monday, 10 months before the products transition in March 2020 from the Food Drug and Cosmetic Act to biologics under the Public Health Service Act.
While a study in healthy volunteers demonstrated bioequivalence of the 2 insulin products, to date, few direct comparisons of the biosimilar and the innovator have been available. A new study compared the efficacy and safety of treatment with each of the products in a retrospective analysis of hospitalized patients with type 2 diabetes and found that the reference insulin provided better fasting glycemic control than the biosimilar.
This week, a research letter published in JAMA gives some insight into how biosimilars of long-acting insulins could impact the cost of insulin therapy for patients with diabetes.
Eli Lilly and Company said Monday it is introducing a lower-priced authorized generic of its insulin lispro injection (Humalog) in the United States. The generic will have a list price 50% lower than the current Humalog list price.
Pfenex and Alvogen announced this week that they have entered into agreements to develop and commercialize PF708, a follow-on teriparatide product referencing Forteo, for the treatment of osteoporosis, in the European Union, some countries in the Middle East and North Africa, and other territories.
The comment period has recently closed for the FDA’s proposed approach to the transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars, and among the comments from stakeholders is a suggestion that one drug maker may be interested in selling biosimilars of its own products.

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