Posted by Michael Wonder on 03 Sep 2015
Health Canada approves new indications for PrOmnitrope (somatropin), Canada’s first subsequent entry biologic (biosimilar)
1 September 2015 - Sandoz Canada Inc., a Novartis company, has received approval from Health Canada for a number of additional indications for PrOmnitrope (somatropin), a recombinant human growth hormone used to treat growth problems in both pediatric and adult patients. PrOmnitrope is Canada's first subsequent entry biologic (biosimilar), which are follow-on versions of original biological molecules and, unlike most generic copies of chemical medicines, undergo their own safety and efficacy clinical studies.
"Health Canada’s approval of additional indications for PrOmnitrope confirms that we continue to be a pioneer in differentiated products," says Michel Robidoux, President of Sandoz Canada. "We are committed to making this high-quality biosimilar available to more patients in Canada, as well as to making the initiation of PrOmnitrope therapy easier. For example, PrOmnitrope's liquid formulation (PrOmnitrope Solution) eliminates the need for reconstitution, and the SurePal pen is designed to make the injection process simple."
For more details, go to: http://www.sandoz.ca/cs/groups/public/@sge_ca/documents/document/n_prod_1562544.pdf
