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EMA accepts MAA for Sandoz’s biosimilar etanercept

8 December 2015 | By Victoria White

Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis...

Ibrutinib shown to be superior to chlorambucil in trial

7 December 2015 | By Victoria White

Janssen-Cilag International NV has announced data from the Phase 3 RESONATE-2 (PCYC-1115) trial that show ibrutinib (Imbruvica) was superior to chlorambucil in all efficacy endpoints measured in patients with treatment-naïve chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) aged 65 or older.

Amgen submits MAA for biosimilar ABP 501 to the EMA

4 December 2015 | By Victoria White

Amgen believes this submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen's first biosimilar to be submitted for approval in the EU...