Issue link: http://clhia.uberflip.com/i/406567
24 At the same time, they can also be very expensive and, as outlined in the introduction of this paper, the growth in biologics is impacting the sustainability of drug plans in Canada. Health Canada defines a SEB, or biosimilar, as a biologic drug that enters the market subsequent to a version previously authorized in Canada, and with demonstrated similarity to a reference biologic drug. 13 To date there has only been one SEB approved in Canada. However, according to Health Canada, there are numerous potential SEB sponsors that will file in 2013. In 2010, Health Canada published its finalized guidance document for the approval of SEBs. However, the SEB approval process is still quite uncertain and open to interpretation and we believe Canadians would benefit from greater clarity on how this process will work. We also believe that it is important that there be a rigorous process to set SEB pricing in Canada. It is logical that the PMPRB should take this on in addition to its current role of regulating prices for new brand drugs and biologics. THEREFORE, THE CLHIA RECOMMENDS THAT: • HEALTH CANADA CLARIFY ITS APPROACH TO REVIEWING AND APPROVING SEBS THROUGH, FOR EXAMPLE, A SPECIFIC REGULATORY PROCESS FOR THE APPROVAL OF SEBS; AND • THE PMPRB SHOULD REVIEW AND REGULATE THE PRICING FOR SEBS GOING FORWARD. 13 Health Canada Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs), 2010/03/05.