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AstraZeneca has announced that Imfinzi® (durvalumab) and Lynparza® (olaparib) combination has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for certain patients with primary advanced or recurrent endometrial cancer. 

New and expanded Pharmaceutical Benefits Scheme (PBS) listings are to be implemented in Australia for AstraZeneca/MSD’s Lynparza® (olaparib), expanded for use for patients with human epidermal growth factor receptor 2 negative (HER2-negative) high-risk early breast cancer w...

On 28 June 2024, the results of a switching study on Fresenius Kabi’s® (MSB11022 adalimumab biosimilar) were published in Current Medical Research and Opinion, following presentation at the 2024 European Congress of Rheumatology (EULAR) earlier in June.  The study demonstra...

On 28 June 2024, Zydus and Dr Reddy’s announced that they have entered a licensing agreement to co-market Zydus’ pertuzumab biosimilar in India.  Dr Reddy’s receives semi-exclusive rights under the agreement, while Zydus will receive upfront and subsequent milestone payment...

Shanghai Henlius Biotech has announced the completion of phase 1 clinical trials of HLX15, biosimilar to Janssen’s Darzalex® (daratumumab).  The studies demonstrated that HLX15 has similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity prof...

Roche has announced that the EMA’s CHMP has issued a positive opinion for extension of the marketing authorisation for Roche’s Vabysmo® (faricimab) to include visual impairment due to macular oedema secondary to retinal vein occlusion.  If approved, faricimab will be the fi...

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...