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Research has backed the use of the recombinant human growth hormone (rhGH) Valtropin® 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 Valtropin’s efficacy in children with growth hormone deficiency.
Lead authors, including Paul Saenger, professor of paediatrics at New York’s Albert Einstein College of Medicine, concluded that: “The 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 September’s issue of Hormone Research.
Biopartners CSO Dr Conrad Savoy said: “Biosimilarity does not mean a compromise between cost and safety.
“Biopartners 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.
“The publication of this data demonstrates that Valtropin is as safe as the reference product which has been widely used for many years now.
“This 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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