Following the first full market approval of a "biosimilar" within the last few weeks (that of Sandoz' Omnitrope, a generic equivalent to Pfizer's Genotropin; Marketletters passim) and imminence of their European marketing debut, a recent survey (of biotechnology groups worldwide) shows that, remarkably, the majority of established western companies now view this as an opportunity, and do not feel threatened by emerging Asian competition. This represents a marked shift in opinion from previously-published articles and surveys.
The survey, commissioned by Eden Biodesign, a UK-based international biopharmaceutical development and manufacturing services business, revealed divided opinions across the continents on how the approval of European and US regulatory pathways for biogeneric products will affect the $60.0 billion biologics industry as a whole.
Within Europe, where the European Medicines Agency (EMEA) has led the way in issuing guidelines to help manufacturers of biogenerics to gain regulatory approval, 83.8% of those surveyed thought that the opening up of the biosimilar market represented an opportunity. UK figures were very similar with 81.8% of the same opinion, the study found.
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