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A Bristol Myers Squibb (BMS) study published in the Journal of Clinical Oncology concluded that Opdivo® (nivolumab) plus chemotherapy did not significantly improve progression-free survival versus chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated...

Sandoz announced that it has signed an agreement to acquire Coherus Biosciences’ Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), for US$170M.  The deal includes the biologics license application (BLA), product inventory, ophthalmology sales and field reimbursem...

PulseNews reported that Samsung Bioepis has received approval for Episcli® (SB12), biosimilar to Alexion’s Soliris® (eculizumab), from the Korean Ministry of Food and Drug Safety.  Episcli® is approved to treat nocturnal hemoglobinuria.
On 3 January 2024 Alexion sued ...

The Therapeutic Goods Administration (TGA) has approved Amgen’s Wezlana®, the first approved biosimilar to Janssen’s Stelara® (ustekinumab), in Australia.  The vial and pre-filled syringe for subcutaneous injection have been approved to treat plaque psoriasis, psoriatic art...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bayer’s Eylea®8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DMO).
Eylea® 8mg was approved in Jap...

On 19 January 2024, an Alvotech-sponsored study, published in the Sage Journal, concluded on the basis of a “totality of evidence approach” that there was no clinically meaningful difference between Alvotech’s AVT02 (adalimumab biosimilar) and AbbVie’s Humira® (adalimumab)....

Alvotech announced that its facility in Iceland received a form 483 from the FDA with only one observation.  The inspection started on 10 January 2024 and has concluded.  Alvotech said it will provide a response to the FDA in the coming days, and that the observation is “re...

The US Food and Drug Administration (FDA) announced that it is adding a Boxed Warning to the prescribing information for Amgen’s Prolia® (denosumab) about the significant risk of developing severe hypocalcemia (very low blood calcium levels) in patients with advanced chroni...

Korea Biomedical Review reported that CanariaBio received a recommendation from Korea’s Data and Safety Monitoring Board (DSMB) that it stop its global phase III clinical trials of oregovomab in ovarian cancer patients, but continue to monitor overall survival.  The recomme...