On September16, 2016, at an all-day NCCN symposium, I had the privilege of providing a keynote address on regulatory aspects and new trends in (a) biosimilars and in (b) molecular diagnostics.
The 40-slide deck is in the cloud here. The NCCN workshop, held in Washington at the National Press Club, has its own webpage here.
Shortly after the meeting, the FDA made its third biosimilar, a copy of Enbrel (etanercept) called Erelzi (etanercept-szzs). Note that biosimilars have both a proprietary name (Erelzi) and a common name with a nonsense four letter extension (in this case, -szzs). The FDA plans to hold one biosimilar advisory committee per reference biologic (here). From a July adcomm, one more biosmiilar approval is pending in the near future, a Humira biosimilar to be made by Amgen.
