Coherus continues to seek partners to help with commercialisation .
Coherus Biosciences is seeking potential licensing partners for commercialising pegfilgrastim biosimilar in the European Union (NB dated 2016) .
UK launch plans not yet available .
Coherus announces planned launch date of Jan 2019 in the US, and a list price of $4,175, a 33% discount to Neulasta .
Coherus BioSciences announced that the FDA has approved Udenyca .
The EC has granted marketing authorization to Udenyca (formerly CHS-1701), a pegfilgrastim biosimilar .
EU positive opinion for reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) .
FDA issues a complete response letter, which includes a request for reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information. The FDA did not request a clinical study to be performed in oncology patients, which would have been a costlier delay. Coherus will work with the FDA to resolve the issues .
EMA has accepted application for European licence, announced Coherus .
Based on latest trial results, US filing now expected Q3 2016 ; company pipeline does not indicate any EU filing target for pegfilgrastim, although EU targets for adalimumab (2017) and etanercept (2016) biosimilars are shown .
Coherus remains on track for its planned BLA filing in the first quarter of 2016 .