Clinical Phase III Trial Data Demonstrate Valtropin's Safety and Efficacy
BAAR, Switzerland -- In a significant development for the emerging field of biosimilars, Biopartners’ recombinant human growth hormone (rhGH) - Valtropin - has demonstrated equivalent safety and efficacy to its reference product. This welcomed communication follows some concerns raised by established biopharmaceutical companies about the safety of biosimilars.
Carried out in Europe, South Africa and the USA, the randomized, double-blind, comparator-controlled phase III trial assessing Valtropin’s efficacy and safety in treatment-naïve children with growth hormone deficiency is now published on line and will be in the September issue of Hormone Research.* The lead investigators and the lead authors, including Paul Saenger, Professor of Paediatrics at the Albert Einstein College of Medicine in New York concluded that “The one year efficacy and safety profile of Valtropin…are equivalent and fully comparable to the comparator rhGHâ€.
“Biosimilarity does not mean a compromise between cost and safetyâ€, said Dr Conrad Savoy, Biopartners’ CSO. “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 central part of the pivotal data submitted to the EMEA and it laid the foundation for the European Commission granting the marketing authorization for Valtropinâ€.
In addition to Valtropin, Biopartners has an innovative sustained release (SR) formulation of rhGH - the only SR-rhGH in advanced Phase III development – aimed at a European market estimated to be worth 250 million USD.
* Vol. 68, No. 6, 2007
About Biopartners Holdings AG
Headquartered in Baar, Switzerland, with an affiliate in Germany, Biopartners is a global biopharmaceuticals company and a leader in the emerging field of biosimilars (multi-source biopharmaceuticals). Biopartners’ mission is to develop biopharmaceuticals and innovative formulations of “first generation†biopharmaceuticals as well as advanced delivery systems that may improve patient compliance. Biopartners is developing a comprehensive range of biopharmaceutical products that may offer life-saving therapeutic benefits across many therapeutic areas. Biopartners has a fourth product in phase III. In March 2007, Biopartners was acquired by Polish biotechnology company Bioton S.A.