Lonza/Teva biosimilar pact in jeopardy

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Lonza/Teva biosimilar pact in jeopardy

Biosimilars/News | Posted 05/04/2013 0 Post your comment

Switzerland-based API producer and custom manufacturing organization Lonza is reviewing whether it is still worth investing in its joint venture for biosimilars with Israeli generics giant Teva Pharmaceutical Industries (Teva).

The two companies established a joint venture to develop, manufacture and market a portfolio of biosimilars back in 2009. However, Lonza is now questioning whether they still want to pursue this area.

Lonza’s Chief Executive Officer, Mr Richard Ridinger, said that ‘a joint venture team is reassessing at the moment whether our assumptions from 2009 are still correct.’ Adding that the cost of developing biosimilars would be ‘considerably more’ than the 100 million Swiss francs (US$105.6 million) per biosimilar the companies estimated in 2009.

The review has been prompted by the suspension of Teva’s phase III trial of its biosimilar version (TL011) of Roche’s arthritis blockbuster Rituxan/MabThera (rituximab) [1]. The suspension was due to Teva ‘considering how best to meet the requirements’ from FDA and EMA. But uncertainty over the regulatory framework for biosimilars in the US, as well as the defence strategies from innovator companies have caused delays and also caused other companies to halt biosimilar development projects.

Lonza apparently wants ‘clarity’ before the company commits to a large investment, and Mr Ridinger failed to comment on whether the biosimilar project could cease to exist.

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 4]. Available from: www.gabionline.net/Biosimilars/News/Teva-halts-phase-III-biosimilar-rituximab-trial

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Source: Lonza, Teva