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Catalent announced a collaboration for the development and manufacture of Valerius’ biosimilar products.   Catalent will provide cell line development and support cGMP manufacturing activities from Phase 1 through to commercial stages from the USA.

FDA approves epoetin alfa biosimilar for the treatment of anaemia caused by chronic kidney disease, chemotherapy or use of zidovudine.

Australia’s NeuClone announces preclinical results for its biosimilar ustekinumab, which are now scheduled for Ph 1 clinical trials in 2019.

Coherus BioSciences discloses that preclinical studies will be ongoing in 2018 for CHS-2020 biosimilar aflibercept.

Coherus provides 2018 forecasts in its Q1/2018 results, including EU approval opinion by 28 June 2018, and US BLA acceptance by 3 June 2018. Commercial discussions ongoing.

Coherus BioSciences confirms its 2022 target launch date for CHS-1420, biosimilar adalimumab.  Commercial partnering options are being considered.

Coherus announces it expects to initiate clinical studies for biosimilar ranibizumab CHS-3351 in 2018.

Lupin announced YL Biologics has filed a BLA for biosimilar etanercept (YBL113) in Japan. YL Biologics is a joint venture between Yoshindo and Kyowa (Lupin’s subsidiary), and YBL113 is the first biosimilar developed by the JV.

Amneal announces it has entered into a licensing agreement with mAbxience for its US biosimilar bevacizumab.  See subsequent mAbxience announcement here.

Celltrion announces that the FDA has rejected its BLA for biosimilars to trastuzumab (CT-P6) and rituximab (CT-P10).  The FDA complete response letter (CRL) followed a FDA warning letter received by Celltrion in January this year.  Celltrion promises that the BLAs will be r...