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The first subsequent entry biologic authorized for market in Canada: the story of Omnitrope, a recombinant human growth hormone

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Omnitrope is the first Subsequent Entry Biologic (SEB)/Similar Biotherapeutic Product (SBP) filed with Health Canada, for purposes of marketing. Health Canada is the home organization of the Regulatory Authority in Canada. As the first SEB to be filed for actu... ...