Manufacturing tweaks to subcutaneous Tecentriq delay Roche's US launch, CMC processes to be updated by year’s end
Roche informed its drug delivery tech partner Halozyme Therapeutics that the US launch of the subcutaneous version of Tecentriq will be delayed to next year due to manufacturing changes. The US decision was initially expected on Sept. 15. Halozyme issued the securities filing on Wednesday.
“The launch of our subcutaneous formulation of Tecentriq in the US will be delayed, as we are making updates to our Chemistry, Manufacturing and Controls (CMC) processes in line with evolved FDA requirements,” a Roche spokesperson told Endpoints News.
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