First Subsequent Entry Biologic Approved in Canada

Sandoz Canada Inc (Sandoz) has gained market authorization in Canada for its recombinant human-growth hormone OMNITROPE (somatropin), which is the first Subsequent Entry Biologic (SEB) to be approved by Health Canada. SEBs are biologic drugs whose authorization depend in part on a demonstration of similarity to a previously approved innovative biologic drug. This demonstration of similarity allows the SEB submission to rely on certain safety and efficacy data of the innovative product. OMNITROPE was also the first SEB approved in the EU and US, with approvals coming in 2006 in both jurisdictions (SEBs are referred to as "Bio-Similar Products" and "Follow-on Protein Products" in the EU and US, respectively). Sandoz subsequently gained approval in the EU for Bio-Similar erythropoietin and G-CSF products. Future SEB submissions will be facilitated by Health Canada's revised draft guidance that addresses the information and submission requirements for SEBs (see "Health Canada Releases Revised Guidance on Subsequent Entry Biologics" E-TIPS®, Vol 7, No 21, April 22, 2009). For a copy of the Sandoz press release, see: http://tinyurl.com/ckbktj Summary by: Michael Migus