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On 15 November 2024, Canada’s Drug Agency (CDA-AMC) published its final recommendation for Eli Lilly’s Ebglyss™ (lebrikizumab), recommending against reimbursement of Ebglyss™ by public drug plans, excluding Quebec, for the treatment of moderate-to-severe atopic dermat...

Regeneron has sued Sanofi, its partner in the commercialisation of the blockbuster eczema drug Dupixent® (dupilumab), in the US District Court for the Southern District of New York alleging that Sanofi is in breach of its commercialisation agreement.  The issues relate to c...

On 18 November 2024, AbbVie announced that European Commission (EC) has approved Elahere® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube or pr...

In April 2024, we reported that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), and published those results in late July.  On 18 November 2024, Celltrion presented additional data from that trial.  Celltrion...

On 13 November 2024, Amgen filed a BPCIA Complaint for Patent Infringement in the US District Court for the Eastern District of North Carolina against Accord Biopharma, Accord Healthcare and Intas Pharmaceuticals.  The Complaint asserts infringement of 34 of Amgen’s US pate...

On 18 November 2024, Samsung Bioepis and Biogen announced that the European Commission has approved Opuviz™/SB15, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).  A positive CHMP opinion was adopted for Opuviz™ in September 2024.

Opuviz™ is approved for the tre...

At the November 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation under exceptional circumstances for InflaRx’s Gohibic® (vilobelimab) for treatment of adults with SARS-CoV2-induc...

On 15 November 2024, Sandoz announced that its Afqlir®, biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), has been approved in Europe for the treatment of nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neo...