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On 3 March 2025, Fresenius announced the US launch of Otulfi®/FYB202 (ustekinumab-aauz), biosimilar to J&J/Janssen’s Stelara®.

FYB202/Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024.  It is being commercialised in the US,...

On 3 March 2025, Eisai and Biogen announced that Australia’s Therapeutic Goods Administration (TGA) has confirmed its initial decision to decline the approval of Leqembi® (lecanemab) for the treatment of early Alzheimer’s Disease (AD).  Eisai is “extremely disappointed and ...

On 3 March 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has accepted for review their aBLA for two new denosumab biosimilars referencing Amgen’s Prolia® and Xgeva®.   The FDA has assigned a target action date in Q4 2025.

The biosimilars are being...

On 3 March 2025, Celltrion announced that it has received US FDA approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the same indications as the reference medicines.  The approval follows European approval ...

On 3 March 2025, Genevant Sciences and Arbutus Biopharma announced that they have jointly filed five international lawsuits seeking to enforce patents protecting their lipid nanoparticle (LNP) technology against Moderna and certain affiliates.  Genevant and Arbutus are seek...

On 1 March 2025, Sandoz’s high-concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) 100mg/mL (80 mg/0.8 mL injection, 0.8 mL pen) was PBS listed for all Humira® indications.

This follows PBS-listing of Hyrimoz® 100mg/mL (40 mg/0.4 mL injection, 2 x 0.4...

On 28 February 2025, Amgen filed petitions for inter partes review (IPR) challenging the validity of three of Bristol Myers Squibb’s US patents relating to methods of treatment using nivolumab and ipilimumab for cancer generally (US 9856320), melanoma (US 10174113) and colo...

At its February 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended expanded therapeutic indications for 16 medicines, including the following six biopharmaceuticals.

The CHMP adopted a positive opinion for ...