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Recent BioBlast® Updates

NICE Recommends Against Trastuzumab Deruxtecan for HER2-Low Breast Cancer

Jul 29, 2024

On 29 July 2024, UK’s NICE (National Institute for Health and Care Excellence) released a statement that it will not recommend the use of trastuzumab deruxtecan (marketed by Daiichi Sankyo/AstraZeneca as Enhertu®) for treatment of HER2-low breast cancer patients after...

Amgen’s Xgeva® PFS Denosumab Approved in Korea

Jul 26, 2024

On 26 July 2024, Korean Ministry of Food and Drug Safety announced the approval of a prefilled syringe formulation of Amgen’s Xgeva® (denosumab). International guidelines recommend Xgeva® for patients with bone metastases from various cancers, and its introduction as...

FDA Issues Alert in Relation to Compounded Imitations of Novo Nordisk’s Ozempic® and Wegovy® (Semaglutide)

Jul 26, 2024

On 26 July 2024, the US FDA issued an alert to healthcare providers in relation to dosing errors associated with compounded injectable semaglutide, including imitations of Novo Nordisk’s Ozempic® and Wegovy®. The FDA has received reports of adverse events, including...

Novo Nordisk’s Wegovy® EU Label Update for Reduction in Major Adverse Cardiovascular Events

Jul 26, 2024

Novo Nordisk A/S announced on 26 July 2024 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a “positive opinion” for an update to the label of Wegovy® (semaglutide 2.4 mg) to reflect a risk reduction of major...

Positive CHMP Opinions For 6 Biosimilars, Including 3 for Ustekinumab

Jul 26, 2024

At its July 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars. Three are biosimilars to Janssen’s Stelara® (ustekinumab): Samsung Bioepis’ Eksunbi, Formycon’s Fymskina...

CHMP Positive Opinions for 2 New Biologics; Extended Indications for 5 and Negative Opinion for 1

Jul 26, 2024

At its July 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Coherus/TMC Pharma’s Loqtorzi® (toripalimab) for nasopharyngeal carcinoma and oesophageal squamous cell carcinoma. The CHMP...

New Indication Alert: EU Approves AbbVie’s Skyrizi® (Risankizumab) for UC

Jul 26, 2024

On 26 July 2024, AbbVie announced European Commission approval of Skyrizi® (risankizumab) for moderate to severe ulcerative colitis (UC). Skyrizi® was already approved in the EU for plaque psoriasis, psoriatic arthritis and moderate to severe Crohn’s disease. The...

Kashiv BioSciences Completes Patient Enrolment in Phase III Biosimilar Omalizumab Trials

Jul 25, 2024

On 25 July 2024, Kashiv BioSciences announced completion of patient enrolment in a Phase III trial of ADL018, its biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab). The study aims to compare ADL018 and Xolair® in terms of efficacy, safety, tolerability,...

Sandoz/Samsung Bioepis’ Ustekinumab Biosimilar Launched in EU

Jul 25, 2024

On 25 July 2024, Sandoz announced the European launch of Pyzchiva®, biosimilar to Janssen’s Stelara® (ustekinumab) for treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and paediatric plaque psoriasis. Although Pyzchiva® is not the first approved...

Bio-Thera’s Pembrolizumab Biosimilar Enters the Clinic in Ph I/III Trial

Jul 25, 2024

On 25 July 2024, Bio-Thera announced commencement of an integrated Phase I/III trial for its BAT3306, biosimilar to MSD’s Keytruda® (pembrolizumab), in non-squamous, non-small cell lung cancer (nsNSCLC). The study will compare the pharmacokinetics, efficacy and...

Sanofi reports Q2 2024 Dupixent® (Dupilumab) Sales Over €3.3B

Jul 25, 2024

On 25 July 2024, Sanofi revealed that its worldwide sales of Dupixent (dupilumab) grew by 29.2% to €3,303 million in the second quarter of 2024. Sanofi expects the product to generate revenue of about €13 billion for 2024. Earlier this month, Dupixent® received...

FDA acknowledges that AstraZeneca’s Imfinzi® (Durvalumab) Phase III Trial Met Primary Endpoint

Jul 25, 2024

On 25 July 2024, AstraZeneca announced the FDA’s Oncologic Drugs Advisory Committee acknowledged that its Imfinzi® (durvalumab) met the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC), based on Phase III...

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Recent BioBlast® Updates

NICE Recommends Against Trastuzumab Deruxtecan for HER2-Low Breast Cancer

Amgen’s Xgeva® PFS Denosumab Approved in Korea

FDA Issues Alert in Relation to Compounded Imitations of Novo Nordisk’s Ozempic® and Wegovy® (Semaglutide)

Novo Nordisk’s Wegovy® EU Label Update for Reduction in Major Adverse Cardiovascular Events

Positive CHMP Opinions For 6 Biosimilars, Including 3 for Ustekinumab

CHMP Positive Opinions for 2 New Biologics; Extended Indications for 5 and Negative Opinion for 1

New Indication Alert: EU Approves AbbVie’s Skyrizi® (Risankizumab) for UC

Kashiv BioSciences Completes Patient Enrolment in Phase III Biosimilar Omalizumab Trials

Sandoz/Samsung Bioepis’ Ustekinumab Biosimilar Launched in EU

Bio-Thera’s Pembrolizumab Biosimilar Enters the Clinic in Ph I/III Trial

Sanofi reports Q2 2024 Dupixent® (Dupilumab) Sales Over €3.3B

FDA acknowledges that AstraZeneca’s Imfinzi® (Durvalumab) Phase III Trial Met Primary Endpoint

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