Should US Insulins Be Treated As Biologics?
Draft Bill Favors ANDA Route For Insulins
Against a backdrop of continued outcry over insulin costs in the US and the looming FDA-imposed transition of insulins to biologic status in early 2020, legislators and manufacturers alike are still lobbying for alternative approaches to the essential diabetes treatment.
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Mylan is preparing to launch a trastuzumab biosimilar in the US, while progress of developing bevacizumab and aflibercept biosimilars continues. Insulin aspart and glargine are also in Mylan’s pipeline.
India’s Biocon has promised to cut by 50% the cost of recombinant human insulin to 10 cents a day in low- and middle-income nations to help make the life-saving medication “universally accessible.”
Novo Nordisk will launch US authorized generics of its NovoLog and NovoLog Mix at half the price of the brands from the start of 2020.