FDA accepts another biosimilar adalimumab for review

Sandoz, the biosimilars and generics division of Swiss pharma giant Novartis (NOVN: VX), says that the US Food and Drug Administration has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab to the reference medicine, Humira, AbbVie’s (NYSE: ABBV)) mega blockbuster drug for the treatment of various immunological diseases, including rheumatoid arthritis,

"When patients are dealing with a chronic disease, it is imperative they have access to important medication that will help best manage their health," said Mark Levick, global head of development, biopharmaceuticals, at Sandoz, adding: "The FDA's acceptance of the regulatory submission for our biosimilar adalimumab brings us one step closer to offering a portfolio of options to the millions of patients in the US who suffer from an inflammatory disease."

Two biosimilars already cleared by FDA