On January 10, the Food and Drug Administration (FDA) released its long-awaited draft guidance on the interchangeability standard for biosimilar manufacturing.
Tag: Biosiimilars
Supreme Court to Hear Sandoz v. Amgen Arguments on the 180-Day Notification Period
It seems that the Supreme Court will in fact hear Novartis’ case in an attempt to overturn the 180-day notification period, as part of the “patent dance.” Its biosimilar-making subsidiary (Sandoz) will finally get its day in the nation’s top court in April, with a decision expected sometime in July.
Are 2 Biosimilars to the Same Originator Product Biosimilar to Each Other?
In Europe, several manufacturers are marketing approved biosimilars to the same originator product. In fact, 7 manufacturers compete for the biosimilar filgrastim market, 5 biosimilar versions of epoetin are sold, and 3 biosimilars of infliximab seek marketshare from Remicade®. In the US, this situation is not a reality yet. It will be one day, however, and … Continue reading Are 2 Biosimilars to the Same Originator Product Biosimilar to Each Other?