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Recent BioBlast® Updates

Outlook Receives FDA Agreement under SPA for Ophthalmic Bevacizumab Formulation Trial

Jan 23, 2024

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...

Phase III of the Checkmate 722 BMS Clinical Trial Shows No Significant Improvement on PFS With Addition of Opdivo® (nivolumab)

Jan 22, 2024

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...

Sandoz to Acquire Coherus’ Cimerli® Ranibizumab Biosimilar for US$170M

Jan 22, 2024

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...

Approval Alert: Samsung Bioepis’ Episcli® (SB12) (eculizumab) Approved in Korea

Jan 22, 2024

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...

First Biosimilar Approval Alert: Amgen’s Wezlana® (ustekinumab) Approved by TGA

Jan 22, 2024

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,...

Approval Alert: Bayer’s Eylea® 8mg (aflibercept) Approved by MHRA

Jan 19, 2024

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...

Study Finds no Clinically Meaningful Difference Between Alvotech’s AVT02 (adalimumab biosimilar) and AbbVie’s Humira® (adalimumab)

Jan 19, 2024

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®...

Alvotech Provides Update on FDA Facility Inspection for AVT02 and AVT04

Jan 19, 2024

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...

FDA adds boxed warning for Amgen’s Prolia® (denosumab)

Jan 19, 2024

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...

CanariaBio Advised to Halt Phase III Trials of Oregovomab

Jan 18, 2024

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...

Study Finds Equivalent Performance Between BAT1806 (tocilizumab biosimilar) and Roche’s RoActemra®(tocilizumab)

Jan 18, 2024

On 18 January 2024, a phase 3 study, published in The Lancet Rheumatology, sponsored by Bio-Thera and Biogen concluded that BAT1806 (tocilizumab biosimilar) was equivalent in efficacy, safety, immunogenicity, and pharmacokinetic in comparison to Roche’s...

MHLW Grants MA to Bayer’s Eylea® 8mg (aflibercept) for nAMD and DMO

Jan 18, 2024

Bayer announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) granted market authorisation (MA) for Eylea® 8 mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DMO). The approval was...