Will Glucagon-like peptide-1 agonists dominate the Type 2 Diabetes market?
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Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) and Viatris Inc. have announced that the FDA has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathway.
Developed by EPG Health for Medthority in collaboration with Biogen®. This content is intended for healthcare professionals only, and it has been funded and reviewed by Biogen® for scientific accuracy.
Provention Bio announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA voted 10 yes and 7 no on the question, "Does the information provided in the background documents and presentations by the Applicant and FDA show that the benefits of MGA 031 (teplizumab) outweigh the risks in support of approval to delay clinical type 1 diabetes mellitus?".