The FDA is sticking with an alphabet soup approach to suffixes for nonproprietary, or proper, names for originator biologics, related biologics and biosimilars. But it's still scratching its head over the naming of interchangeables. One of a spate of guidances the agency issued last Thursday in the waning days of the Obama administration, the final guidance calls for biologic proper names to consist of a meaningless, four-letter, lowercase suffix attached to the core name with a hyphen. The FDA is encouraging the routine use of the suffixes in ordering, prescribing, dispensing, record keeping and pharmacovigilance practices.

In what could become an obstacle for biopharma patent trolls, the U.S. Court of Appeals for the Federal Circuit ruled last week that having the right to file an appeal of a Patent and Trademark Appeals Board (PTAB) decision does not change the standing requirements to pursue the appeal in the appellate court. The decision, in Phigenix Inc. v. Immunogen Inc., upheld Waltham, Mass.-based Immunogen Inc.'s '856 patent relating to huMab4D5 ANTI-ErbB2 antibody-maytansinoid conjugates.