Read our latest updates & insights

Janssen announced that the FDA has approved Tremfya® (guselkumab) for the treatment of adults with plaque psoriasis.

Amgen/Allergan’s biosimilar becvacizumab recommended for approval by FDA ODAC. Read more 

Amgen’s biosimilar BmAb goes before the FDA Oncology Drugs Advisory Committee in the morning session on 13 July 2017. Read more

FDA accepted Teva/Celltrion’s aBLA for CT-P10, biosimilar rituximab.

Biosimilar etanercept (Erelzi®) approved in EU to treat multiple inflammatory diseases.

Imraldi®, Samsung’s adalimumab biosimilar (SB5) receives positive opinion from CHMP in EMA.

EU approval received for Sandoz’s Rixathon® (biosimilar rituximab) to treat blood cancers and immunological diseases.

FDA sends Complete Response Letter regarding Coherus’ Neulasta biosimilar 351(k) application for CHS-1701.

Celltrion files BLA for Herzuma®, biosimilar trastuzumab, to be marketed by Teva.

Fujifilm announces EC has accepted its MA for biosimilar adalimumab (FKB327) which Fujifilm filed in April 2017.   Clinical trials were conducted in RA and commenced in Dec 2014.