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On 1 July 2024, South Korea’s Alteogen announced that its subsidiary Altos Biologics submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its ALT-L9, biosimilar to Regeneron’s Eylea® (aflibercept).  According to the press release,...

On 1 July 2024, The Korea Herald reported that EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended European marketing authorisation for Steqeyma (CT-P47), biosimilar to Janssen’s Stelara® (ustekinumab), for plaque psoriasis, psoriatic arthritis, and ...

On 1 July 2024, Samsung Bioepis announced that the FDA approved its Pyzchiva® (SB17), biosimilar to Janssen’s Stelara® (ustekinumab) for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s...

Tanvex has announced that the FDA has approved its Nypozi® (TX01), biosimilar to Amgen’s Neupogen® (filgrastim). Nypozi® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppr...

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...