Read our latest updates & insights

NeuClone commences Phase I clinical trials for biosimilar trastuzumab.

Mylan announces launch of Hulio®, biosimilar adalimumab in Europe.

In advance of US biosimilar competition, Genentech announces expanded indication set, including follow up treatment in adult patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) who have achieved disease control with induction treatment.

Mylan and Biocon announce the CHMP’s positive opinion recommending Ogivri® (biosimilar TmAb) for approval in EMA.  Approval is expected before the end of the year.

AbbVie and Fresenius separately announce global deal with Fresenius Kabi under which Fresenius has a US licence from 30 Sept 2023 (the same date as Sandoz), and may sell in EU on approval.  The deal is global, and different dates apply for other regions.  The Fresenius (and...

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.