In a significant development for the emerging field of
biosimilars, Biopartners' recombinant human growth hormone (rhGH) -
Valtropin(R) - 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-naive 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 rhGH".
"Biosimilarity does not mean a compromise between cost and
safety", 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 Valtropin".
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.