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Research has backed the use of the recombinant human growth hormone (rhGH) ValtropinÂ® following concerns from some biopharmaceutical companies about the safety of biosimilars.
The randomised, double-blind, comparator-controlled phase III trial, carried out in Europe, the USA and South Africa, assessed Valtropinâ€™s efficacy in children with growth hormone deficiency.
Lead authors, including Paul Saenger, professor of paediatrics at New Yorkâ€™s Albert Einstein College of Medicine, concluded that: â€œThe one-year efficacy and safety profile of Valtropin are equivalent and fully comparable to the comparator rhGH.â€
The findings on the drug, manufactured by Swiss firm Biopartners, will be published in Septemberâ€™s issue of Hormone Research.
Biopartners CSO Dr Conrad Savoy said: â€œBiosimilarity does not mean a compromise between cost and safety.
â€œBiopartners is committed to ensuring that its biosimilars and innovative biopharmaceuticals are rigorously tested for safety and efficacy, including appropriately designed and managed clinical phase III trials.
â€œThe publication of this data demonstrates that Valtropin is as safe as the reference product which has been widely used for many years now.
â€œThis evidence is a central part of the pivotal data submitted to the EMEA and it laid the foundation for the European Commission granting the marketing authorisation for Valtropin.â€
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