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WuXi XDC and Celltrion announced that they have signed a memorandum of understanding (MOU) for development and manufacturing of bioconjugates including antibody-drug conjugates (ADCs).  Under the agreement, WuXi will be Celltrion’s primary service provider for its projects,...

Outlook Therapeutics announced it received an agreement from the FDA under a Special Protocol Assessment (SPA) for its clinical trial protocol to assess ONS-5010, an ophthalmic formulation of bevacizumab.  Outlook expects to commence the trial in Q1 2024, with potential res...

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...