Read our latest updates & insights

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...

On 15 November 2024, Regeneron and Sanofi announced that the US FDA has accepted for review their resubmitted supplemental Biologics Licence Application (sBLA) for Dupixent® (dupilumab) for patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose dise...

On 14 November 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Samsung Bioepis’ Obodence™ (SB16/denosumab) and Xbryk™ (SB16/denosumab), biosimilars to Amgen’s Prolia® and Xgeva®, respectively.

...

On 14 November 2024, Sanofi announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (V...

On 14 November 2024, Eisai reported that it has received a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of Leqembi® (lecanemab) for use in treating patients with mild cognitive impairm...

On 14 November 2024, Merck (known as MSD outside the US and Canada) announced that it has entered an exclusive global licence agreement with Shanghai-based LaNova Medicines Ltd to develop, manufacture and commercialise LM-299, LaNova’s investigational PD-1/VEGF bispecific a...