On July 28, 2021, the Food and Drug Administration (FDA) announced the approval of the first “interchangeable biosimilar”—in this case Mylan Pharmaceticals Inc.’s Semglee® (insulin glargine-yfgn), which is both biosimilar to, and interchangeable with, its reference product Lantus® (insulin glargine), a long-acting insulin analog. Acting FDA Commissioner Janet Woodcock, M.D. called it a “momentous day.”… Continue Reading
This past summer, a divided Federal Circuit panel found, in the case of Amgen v. Sandoz, that the so-called “patent dance” under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is optional. This past Friday, the Federal Circuit declined to rehear that decision. Its decision provides biosimilar developers with continued choice while opening … Continue Reading
