Sandoz Canada’s HGH Biosimilar Approved

Sandoz Canada received market authorization for Omnitrope in Canada. Omnitrope is the first biosimilar of a previously approved recombinant drug to be approved by Health Canada under Subsequent Entry Biologic (SEB).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Sandoz Canada received market authorization for Omnitrope in Canada. Omnitrope is the first biosimilar of a previously approved recombinant drug to be approved by Health Canada under Subsequent Entry Biologic (SEB). Omnitrope, a somatropin (rDNA origin) for injection, is approved for the long-term treatment of children with growth failure due to an inadequate secretion of endogenous growth hormone, and long-term replacement therapy in adults with growth hormone deficiency due to an underlying...

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