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On 24 September 2024, Alvotech submitted a Citizen Petition to the FDA requesting that the FDA refuse to designate any ustekinumab biosimilar as “interchangeable” with Janssen’s Stelara® that is manufactured using a CHO cell-line system, until the FDA has evaluated th...

On 23 September 2024, Celltrion announced that it presented the 52-week results of its Phase 3 trial of Eydenzelt™ (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept), at the European Society of Retina Specialists (EURETINA) conference held from 19-22 September in Barc...

On 23 September 2024, the United States District Court for the Northern District of West Virginia denied Regeneron’s motion for a preliminary injunction against Amgen seeking to prevent it from launching Pavblu™, biosimilar to Regeneron’s Eylea® (aflibercept), in the US.  T...

On 23 September 2024, UCB announced that its Bimzelx® (bimekizumab-bkzx) has received FDA approval for active psoriatic arthritis, active non-radiographic axial spondyloarthritis with objective signs of inflammation and active ankylosing spondylitis.  UCB reports that Bimze...

On 20 September 2024, Sanofi announced that the US FDA has approved Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible f...

On 20 September 2024, Astellas Pharma announced that the European Commission has approved Vyloy™ (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or me...

On 19 September 2024, Johnson & Johnson (J&J) announced that it received FDA approval for Rybrevant® (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metast...

At its September 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biologics, each of which was designated as an orphan medicine during development, and recommended indication extensio...

At its September meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Sandoz’s and Samsung Bioepis/Biogen’s biosimilars to Regeneron’s Eylea® (aflibercept).  Both Sandoz’s Afqlir™ and Samsung Bioe...