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On 28 June 2024, Formcyon and Klinge Biopharma GmbH announced that FDA has approved FYB203, biosimilar to Regeneron’s Eylea® (aflibercept) for nAMD, Diabetic Macular Edema, Diabetic Retinopathy and Macular Edema following Retinal Vein Occlusion.  Klinge, which holds the glo...

On 28 June 2024, AbbVie announced its acquisition of Celsius Therapeutics, a privately owned biotech firm developing treatments for patients suffering from inflammatory diseases. This includes  CEL383, an anti-TREM1 antibody which has successfully completed a Phase 1 clinic...

On 27 June 2024, Korea Biomedical Review reported that Samsung Bioepis intends to launch its ustekinumab biosimilar Epyztek™ in Korea in July 2024.  The product will be supplied at a 40% discount to J&J’s Stelara® (ustekinumab). 

Celltrion’s Steqeyma (CT-P43), bi...

On 27 June 2024, Coherus BioSciences announced that it has agreed to divest its Yusimry™, biosimilar to AbbVie’s Humira (adalimumab), to Hong Kong King-Friend (HKF) for up-front all-cash consideration of USD $40M.  On the same day, Meitheal Pharmaceuticals, wholly owned sub...

At its June 2024 meeting, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Celltrion’s Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab).  The recommendation is for moderately to severely active Crohn’s disease, plaqu...

On 27 June 2024, Harbour Biomed announced that it has resubmitted its Biologics License Application (BLA) for batoclimab (HBM9161) to the China’s National Medical Products Administration (NMPA) for the treatment of generalized myasthenia gravis. The resubmission voluntarily...

Novo Nordisk announced that Wegovy® has been approved in China for long-term weight management, targeting patients with a BMI of 30kg/m² and at least one weight-related comorbidity.   

The approval comes as the company plans a $4.1 billion expansion of its US manufac...

On 25 June 2024, Simcere Zaiming announced the approval of Enlituo® (cetuximab beta) in the PRC for use in combination with the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC). The drug was developed in collaboration with...