Endocrinology

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.
Despite the fact that the World Health Organization classifies insulin as an essential medicine that should be available at all times at a price that patients can afford, US insulin prices have continued to climb in recent years.
Sandoz has entered into an agreement with Chinese drug maker Gan and Lee to commercialize biosimilar insulins to treat patients with type 1 and type 2 diabetes.
Mylan and Biocon jointly announced earlier this month that their biosimilar insulin glargine, sold as Semglee and referencing Lantus, has launched in the United Kingdom.
In a recently published bipartisan report, representatives Diana DeGette, D-Colorado, and Tom Reed, R-New York, co-chairs of the Congressional Diabetes Caucus, released findings from a year-long inquiry into the sources of ever-increasing insulin prices.
“Comparison of estimated prices with recent government procurement prices suggests that robust competition in the human insulin and insulin analogue market would lead to sizeable savings in most countries and that current manufacturers could set significantly lower prices while still making a profit,” write the study’s authors. 
While US patients with diabetes await the launch of the follow-on, which is expected to offer a welcome cost-savings, newly published data from a 52-week clinical trial in patients with type 1 diabetes (T1D) underscore its similar safety and efficacy to the reference insulin glargine. 
 
At the American Diabetes Association’s 78th Scientific Sessions, researchers presented ways in which education—for both patients and providers—can help improve the care of patients with diabetes who use biosimilar or follow-on insulins.
Mylan and its partner Biocon have received a Complete Response Letter from the FDA in regard to their application for a follow-on insulin glargine referencing Lantus.
Recently, the American Diabetes Association (ADA) released a set of policy recommendations to improve patient access to much-needed insulin and to lower the substantial cost to treat diabetes. 

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