Read our latest updates & insights

Sandoz reports etanercept biosimilar is comparable to originator at 48 weeks.

FDA approves Sandoz adalimumab biosimilar Hyrimoz® for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spodylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.

Samsung announces Phase III trials of ranibizumab biosimilar are underway.

Regeneron announces completion of Phase III clinical trials of Eylea® (aflibercept) in patients with moderately severe and severe non-proliferative diabetic retinopathy.  The company reported the trial met its one year primary endpoint and key secondary endpoints.

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.