Lonza has made a statement refuting reports that the Switzerland-based company was considering backing out of its biosimilars joint venture with Israeli generics giant Teva Pharmaceutical Industries (Teva).
Lonza not backing out on biosimilars
Biosimilars/News | Posted 12/04/2013 0 Post your comment
The reports were based on a recent interview with Lonza’s CEO, Mr Richard Ridinger in which he had said that ‘a joint venture team is reassessing at the moment whether our assumptions from 2009 are still correct’ and had called into question whether Lonza’s joint venture with Teva to produce biosimilar drugs would continue to exist.
In its statement on 5 April 2013, Lonza said that ‘the potential to develop, manufacture and market affordable, efficacious and safe biosimilars remains an area of significant opportunity for both Teva and Lonza. The company added that ‘the Teva Lonza partnership continues to explore this opportunity.’
FDAs lack of clear guidance on the biosimilar pathway has caused delays and has led to companies, including Teva, to halt biosimilar development projects [1]. This was not disputed by Lonza, who said ‘there is significant regulatory uncertainty in the biosimilars arena at present.’
Lonza and Teva are therefore ‘taking a measured approach, choosing to fully evaluate the prevailing regulatory and commercial circumstances before agreeing on further long-term investment decisions that both partners are comfortable with.’
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Teva halts phase III biosimilar rituximab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 12]. Available from: www.gabionline.net/Biosimilars/News/Teva-halts-phase-III-biosimilar-rituximab-trial
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Source: Lonza
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