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BmAb biosimilar approved by China’s National Medical Products Administration for clinical development for Non-Small Cell Lung Cancer and hepatocellular carcinoma.

Sandoz, Samsung and Amgen launch their biosimilar adalimumab products (Hyrimoz®, Imraldi® and Amgevita®) pursuant to the terms of their IP licences with AbbVie.  Mylan also has EMA approval (but no AbbVie EU IP licence) but has indicated an intention to launch their biosimi...

BmAb biosimilar approved for Phase I and Phase III Clinical Trials by NMPA. 

AbbVie announces global settlement with Sandoz, under which Sandoz receives a royalty-bearing, non-exclusive licence to AbbVie’s Humira® patents from 30 Sep 2023 in the US, and 16 Oct 2018 in EU (and other dates elsewhere).  The EU date is the same as AbbVie has given...

Munidpharma acquires Cinfa Biotech, gaining immediate access to pegfilgrastim biosimilar and a platform to potentially develop more biosimilars in the future.

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...