Regulatory Decision Summary for Omnitrope
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
Omnitrope (somatropin) was authorized as a Subsequent Entry Biologic (SEB) April 20, 2009. This Supplement to a New Drug Submission (SNDS) was filed to propose a Product Monograph (PM) update to include use in three additional indications - small for gestational age (SGA), idiopathic short stature (ISS) and Turner Syndrome (TS), in line with additional indications added to the reference product Genotropin PM, dated February 7, 2013. The SNDS proposal is based upon an extrapolation of indication platform. At the time of the initial New Drug Submission (NDS) filing for Omnitrope, Genotropin did not hold the SGA, ISS and TS indications in Canada; however, these indications were held by Genotropin EU, which was considered as the Canadian reference product.
Why was the decision issued?
Overall, in terms of the initial SEB NDS and Notice of Compliance (NOC), sufficient scientific evidence that Omnitrope binds to the GH receptor, has similar PK and PD characteristics to Genotropin, and yields efficacious clinical results in pediatric GH deficiency based on Omnitrope-specific clinical data, has been previously provided. In addition, post-marketing manufacturing changes for Omnitrope are not considered to be of any significant effect on the originally established similarity. Therefore, a satisfactory scientific rationale in favour of allowing the three indications proposed, as based on indication extrapolation platforms, is considered to have been established.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.