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FDA approves Sandoz’s Erelzi® for all indications included in the reference product label, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.

Amgen announces FDA Advisory Committee Meeting to review ABP 501 (biosimilar adalimumab).  FDA has set a Biosimilar User Fee target action date of 25 September 2016.

FDA’s Arthritis Advisory Committee reviews data supporting Amgen’s BLA for ABP 501 (biosimilar adalimumab).

Biogen/Samsung Biopeis receive EMA approval for Flixabi®, biosimilar Infliximab.

Sorrento releases results of Phase II and III clinical trials of biosimilar omalizumab, announcing the candidate STI-004 demonstrated clinical efficacy and safety.

Pfizer/Celltrion received FDA approval for Inflectra®, biosimilar infliximab.

EU’s CHMP gives green light for Flixabi®, Samsung Bioepis’ biosimilar infliximab.

Samsung Bioepis files suit in the UK to remove Abbvie patents regarding adalimumab.

EMA accepts Sandoz’s filing for Zioxtenzo, biosimilar pegfilgrastim.

EMA approves Benepali®, biosimilar etanercept (SB4) for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. CHMP positive opinion was announced on 20 Nov 2015.  Samsung says it developed, tested and had its Benepali® app...