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Australia’s Neuclone discloses the 5th product in its pipeline is biosimilar denosumab, which is at the pre-clinical stage.

Glenmark announces the launch of biosimilar adalimumab (developed by Zydus, marketed as Adaly®), in India.

Mylan and Momenta announce deal relating to the development of M710, biosimilar aflibercept.  Pivotal clinical trials are planned for early 2018.

Roche has sued Sandoz in the Federal Court in Sydney over its recent approval of Riximyo®, alleging infringement of 5 patents: AU2008207357, 761844, 2005211669, 2009201403, and 2007242919.

FDA approves biosimilar infliximab, Ixifi® for the treatment of patients with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriosis.

FDA approves Mylan/Biocon trastuzumab biosimilar Ogivri® for all “on-label” indications.  This is the first US approved trastuzumab biosimilar, and Mylan’s first US biosimilar approved.

The Australian government’s biosimilar uptake initiative results in changes to PBS listing for Samsung’s Brenzys® in Australia. “A” flagging (substitution at the pharmacy level) remains unchanged.

Sandoz’s biosimilar etanercept (Erelzi®)  approved in Australia in 3 dosages, the second approved biosimilar etanercept.

Sandoz’s biosimilar rituximab, Riximyo® approved in Australia, following its approval in Europe 5 months earlier.

German Formycon announced it intends to bring biosimilar ranibizumab to the US market in 2020 with commercialisation partner Bioeq (JV between Santo and Polpharma).