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US’ Oncologic Drug Advisory Committee unanimously recommends Celltrion’s CT-P10 for approval as a biosimilar to Rituxan.

Fresenius Kabi announces that clinical trials for Neulasta® biosimilar met primary endpoints for EU and US.

MSD secures 5 year, $117.5M deal with US Department of Veterans Affairs to supply rituximab biosimilar developed by Samsung.

Xbrane announces biosimilar ranibizumab shows equivalent pharmacokinetic profile and equivalent tolerability to originator in study conduct in rabbits.

US-Mexico-Canada Agreement includes 10 year exclusivity period for biologic drugs, raising concerns that competition will be hindered to the disadvantage of consumers and health services in those regions. Currently the exclusivity period stands at 8 years in Canada and 5 ye...

Momenta announces a shift in focus from biosimilars to novel therapeutics. The 5 year re-structuring plan will involve cuts to staff of 50%, however the company will continue to develop biosimilar aflibercept candidate M710.

Momenta announces an end to its strategic review, revealing a sole focus to advance a Humira® biosimilar. Momenta announced it will file a BLA with the FDA and is working to find a commercialisation partner for the product. 

FDA accepts BLA for biosimilar adalimumab. 

Mylan announces the EU approval of Hulio®, biosimilar adalimumab licensed from Fujifilm in April 2018.

Researchers release results of pre-clinical study of cetuximab candidate APZ001.