biological products previously licensed and newly licensed under sections 351(a) and 351(k) of the PHS Act. The FDA states that applying the naming convention to all biological products will (1) encourage routine use of designated suffixes in ordering, prescribing, dispensing, and record-keeping practices and (2) avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway. At present, the FDA is also proposing a regulation to designate official names and proper names for a small group of biological products that follows this naming convention: These products are filgrastim-sndz (Biologics License Application (BLA) 125553), filgrastim (BLA 103353), tbo-filgrastim (BLA 125294), pegfilgrastim (BLA 125031), epoetin alfa (BLA 103234), and infliximab (BLA 103772). The official names and proper names of these products would include distinguishing suffixes composed of four lowercase letters and would be filgrastim-bflm (BLA 125553), filgrastim-jcwp (BLA 103353), filgrastim-vkzt (BLA 125294), pegfilgrastim-ljfd (BLA 125031), epoetin alfa-cgkn (BLA 103234), and infliximab-hjmt (BLA 103772). The proposed naming convention would apply to all biological products, but the FDA is considering two approaches when it comes to naming interchangeables: (1) names distinct from the reference product where the interchangeable has a unique suffix of four lowercase letters for use as the distinguishing identifier included in the proper name designated by FDA, or (2) names shared with the reference product where the interchangeable product and the reference product would have the same core name and suffix. The FDA specifically requests feedback from the public about whether the nonproprietary name for an interchangeable product should include a distinct suffix, or should share the same suffix as its reference product. To ensure your comments on the draft guidance are considered by the FDA before it begins work on the final version of the guidance, the agency requests comments be submitted before October 27, 2015.

Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact. Terry Rea Partner – Washington, D.C. Phone: 202.624.2620 Email: trea@crowell.com Mary Anne Schofield, Ph.D. Counsel – Washington, D.C. Phone: 202.624.2643 Email: mschofield@crowell.com Deborah H. Yellin Partner – Washington, D.C. Phone: 202.624.2947 Email: dyellin@crowell.com 2 .