The reports were based on an interview in Swiss German newspaper ‘Finanz and Wirtschaft’ last week in which Lonza CEO Richard Ridinger said that business plans made when the joint venture (JV) was formed in 2009 are currently under review.
However, Lonza spokesman Dominik Werner told in-Pharmatechnologist.com Ridinger’s comments were not accurately represented in subsequent reports based on the interview by other media outlets which suggested the partnership itself was facing uncertainty.
“He didn’t say anything about whether to continue the joint venture or not, but rather reviewing the initial assumptions due to unclear regulatory pathway and new, updated assessment of economic assumptions and assess the portfolio within the joint venture.
“Biosimilars remain an attractive market opportunity and both parties stay fully committed to the TL collaboration” he continued.
Regulatory questions
But while Lonza may still be committed to the partnership, suggestions that the continuing lack of regulatory guidance in the US - predicted to be the biggest market for biosimilars - had prompted the review may be nearer the mark.
Werner told us that: “Given the changes and still remaining uncertainties related to the regulatory environment, Teva and Lonza are reviewing the path forward to better understand the change in regulatory environment as well as the commercial impact also in relation to assumptions originally taken.”
He added that further updates will be provided once new information is available.
Trial halt
News of the strategy review follows a few months after Teva halted a Phase III trial of TL011, a biosimilar version of Swiss drugmaker Roche’s Rituxan/MabThera (rituximab).
According to a report in Israeli newspaper Haaretz at the time development was suspended while the Israeli drugmaker considered how best to comply with US and European regulations on the clinical assessment of biosimilar products.
The paper also said that Lonza had been involved in the development of TL011 as part of the 2009 JV as did Bloomberg in its report of the trial suspension.
Teva did not respond to requests for comment ahead of publication.