FDA accepted one biosimilar application from Sandoz Company in July 2014, which imitated Filgrastim of Amgen (recombinant human granulocyte colony-stimulating factor). It was the first time that FDA had accepted biosimilar application. The Oncologic Drugs Advisory Committee subordinate to FDA will organize the examination of the above application in January 2015, according to FDA. But FDA has not published the comparison guide yet regarding whether the biosimilar and its original drug are identical. This guide will have a great impact on American biological products, especially on the market of monoclonal antibody.
However, according to some analysts, it may be very difficult to distinguish "identical generic drug" and "normal generic drug" because even the standards of the normal generic drugs are very high. There may be 2 kinds of distinguishing methods which are incomplete: one is to stipulate that there must be no analysis index differences for the identical generic drug, and non-significant differences are allowed for the normal generic drug; the other one is to stipulate that the identical generic drug must prove to have all the identical efficacy by clinical research. There is currently no provisions of "identical generic drug" in EMA, but France has stipulated that biosimilars and original drugs can be deemed to be the same in pharmacies.
