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AbbVie announces a 6th global deal for biosimilar AmAb, this time with Momenta.  Momenta has obtained a global royalty bearing licence beginning on 20 November 2023 for the US, and in the EU “on approval” (no other dates disclosed). Momenta will be able to launc...

FDA approves Coherus’ biosimilar pegfilgrastim Udencya® for patients receiving myelosuppressive chemotherapy. This is the first US/EU approved biosimilar approved for this indication.

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.