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Sandoz announces it will not pursue biosimilar rituximab in the US following requests from the FDA for additional information to complement the BLA.

Sandoz’s biosimilar Zarxio® is included in Express Script’s 2018 National Preferred Formulary.

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.