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Mylan’s biosimilar trastuzumab goes before the FDA Oncology Drugs Advisory Committee in the afternoon session on 13 July 2017, and receives unanimous recommendation for approval by FDA OCAC.

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.