Mylan and Biocon have received US Food and Drug Administration approval for their Semglee (insulin glargine) vial and pre-filled pen formulations, for which Mylan is continuing to fight to achieve an interchangeability designation with Sanofi’s Lantus (insulin glargine) multi-billion-dollar blockbuster.
Launch timing was not crystalized by either firm, but Mylan observed that its previous successes in toppling Sanofi’s intellectual property meant any appeals from the originator were not, in Mylan’s opinion,
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