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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
The biopharmaceutical company Biopartners recently published data that showed its biosimilar "Valtropin" (somatropin), a recombinant human-growth hormone product, demonstrated the same safety and efficacy as Eli Lilly’s "Humatrope" in children with growth hormone deficiency.
Baar, Switzerland (Aug. 23)-The biopharmaceutical company Biopartners recently published data that showed its biosimilar “Valtropin” (somatropin), a recombinant human-growth hormone product, demonstrated the same safety and efficacy as Eli Lilly’s (Indianapolis, IN) “Humatrope” in children with growth-hormone deficiency, according to an online abstract and article published in Hormone Research (1).
European authorities approved Valtropin in May 2006 for treating Turner’s syndrome and human-growth deficiency in children. At the time of its approval, the product was only the second biosimilar drug to receive EU marketing authorization from the European Commission. Biopartners has codeveloped several biopharmaceutical products with LG Life Sciences (Seoul, South Korea), including Valtropin and a sustained-release formulation of Valtropin. Biopartners in-licensed Valtropin from LG Life Sciences and has commercialization rights for Valtropin in Europe, Japan, and other parts of Asia, according to company information.
Valtropin is a recombinant human-growth hormone manufactured using a novel yeast-expression system. The data concluded that the one-year efficacy and safety profile of Valtropin are equivalent to those of Humatrope. Valtropin can be used to treat children with growth-hormone deficiency, and longer-term data will fully establish its efficacy and safety profile, according to the research (1).
1. V. Peterkova et al., “A Randomized, Double-Blind Study to Assess the Efficacy and Safety of Valtropin, a Biosimilar Growth Hormone, in Children with Growth Hormone Deficiency,” Hormone Research 68 (6), 288–293, 2007.