Issue link: http://clhia.uberflip.com/i/406567
25 b.3.5 Interchangeability of SEBs and Safe Switching Health Canada determines bio-equivalency between generic and brand drugs. The provincial government regulations then define rules for a pharmacist's ability to interchange a generic drug for a brand name drug. In the case of SEBs, however, Health Canada has stated that they are not generic biologics and therefore authorization of an SEB is not a declaration of pharmaceutical or therapeutic equivalence to the reference biologic drug. Therefore, SEBs are not interchangeable according to the process used for generic drugs. While the industry recognizes that this is a challenging area, it is important that a process for establishing the interchangeability of SEBs be pursued. In this regard, Canada should look to work that has been done in other jurisdictions. For instance, according to the U.S. Biologics Price Competition and Innovation Act of 2009, a biologic is considered interchangeable if it "can be expected to produce the same clinical result as the reference product in any given patient." In addition, a standardized clinical guideline for safe switching from a biologic drug to its SEB would be beneficial for public and private payers and patients in Canada. How to safely switch from a biologic to a SEB is a complex issue that would be well suited to a standardized approach that is driven by the best available medical evidence. THEREFORE, THE CLHIA RECOMMENDS THAT: • HEALTH CANADA DEVELOP A POLICY AND PRACTICE WITH RESPECT TO DESIGNATING SEBS AS BIO-EQUIVALENT (AND HENCE INTERCHANGEABLE) AND THAT THIS BE INFORMED BY THE WORK UNDERWAY IN OTHER JURISDICTIONS; AND • THE COUNCIL OF THE FEDERATION'S HEALTH CARE INNOVATION WORKING GROUP DEVELOP NATIONAL CLINICAL GUIDELINES FOR WHAT WILL CONSTITUTE SAFE SWITCHING FROM BIOLOGICS TO SEBS THAT ARE GROUNDED IN THE BEST AVAILABLE MEDICAL EVIDENCE.