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On 6 March 2024, the FDA announced its approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for treatment of adults with unresectable or metastatic urothelial carcinoma.   

Previously in February 2024 and in December 2023, BMS announced that the FDA accepted its sBL...

On 5 March 2024, a study published in Modern Rheumatology found that LG Chem’s LBEC0101, the biosimilar of etanercept, matches up to the reference product in terms of effectiveness and safety in the real-world treatment of rheumatoid arthritis. This evidence was gathe...

Johnson and Johnson (J&J) and Janssen have filed a Motion to Dismiss a class action brought by several US health insurers alleging the companies unlawfully delayed biosimilar competition for Stelara® (ustekinumab) in the US.  J&J/Janssen argue that the alleged facts...

On 5 March 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Genentech’s/Roche’s Actemra®, for the treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.  T...

On 5 March 2024, the FDA approved the first denosumab biosimilars in the US in Sandoz’s Wyost® and Jubbonti®.  The biosimilars are interchangeable with, and approved for all indications of, Amgen’s Xgeva® and Prolia® respectively. 

The US launch date for the ne...

Novo Nordisk announced the results of its Ozempic® (semaglutide 1.0mg) FLOW study kidney outcomes.  In this study, semaglutide 1.0 mg was compared to placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiova...

On 5 March 2024, the Times of India reported that Roche launched Vabysmo® (faricimab) in India for the treatment of age-related macular degeneration (nAMD) and diabetic macular edema (DME).    

Vabysmo® was first approved in the US by the FDA in January 2022 and is n...

A paper published in Nature Communications on 5 March 2024 regarding a Phase II clinical trial sponsored by Arcagy-GINECO showed that FKB238 (bevacizumab biosimilar) + olaparib + durvalumab combination showed better survival for treatment of patients with relapsed ovarian c...

On 4 March 2024, Sandoz announced the completion of its acquisition of biosimilar CIMERLI® (ranibizumab) from Coherus BioSciences. This VEGF inhibitor ranibizumab was approved by the FDA on 2 August 2022 and is indicated for the treatment of retinal diseases. The acquisitio...