Read our latest updates & insights

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...

Coherus announces resubmission of its BLA for biosimilar Peg-Filgrastim CHS-1701

Sandoz announces that the FDA has provided a CRL rejecting its BLA for biosimilar rituximab.

Formycon/Bioeq announce interim positive results for their ph III studies for biosimilar ranibizumab FYB201.

Mundipharma announces their biosimilar trastuzumab (in-licensed from Celltrion) is available in Europe. This is Mundi’s third biosimilar to be launched in EU, but the second biosimilar TmAb, following MSD’s launch in March 2018.