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Recent BioBlast® Updates

Amneal and Kashiv Partner on Omalizumab Biosimilar in US

Jul 1, 2024

On 1 July 2024, Amneal Pharmaceuticals and Kashiv Biosciences announced that they have entered into an exclusive licence agreement for the US in relation to ADL018, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab). ADL018 was developed by Kashiv and is...

Alteogen Subsidiary Submits EU Application for Aflibercept Biosimilar

Jul 1, 2024

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...

Celltrion’s Ustekinumab Biosimilar Recommended by EMA’s CHMP

Jul 1, 2024

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...

Approval Alert: Samsung Bioepis’ Ustekinumab Biosimilar Approved in US

Jul 1, 2024

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...

Approval Alert: Tanvex’s Filgrastim Biosimilar Approved by the FDA

Jul 1, 2024

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...

AZ Imfinzi/Lynparza Combo Recommended for EU Approval

Jul 1, 2024

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...

New and Expanded PBS listings for breast cancer, leukaemia and lupus treatments

Jul 1, 2024

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...

Fresenius Adalimumab Switching Study Confirms Safety and Efficacy

Jun 28, 2024

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...

Zydus’ Pertuzumab Biosimilar to be Co-Marketed in India with Dr Reddy’s

Jun 28, 2024

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...

Shanghai Henlius Biotech Completes Phase 1 Trials for Daratumumab Biosimilar

Jun 28, 2024

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...

New Indication Alert: Positive CHMP Opinion issued for Third Indication of Roche’s Vabysmo® (Faricimab)

Jun 28, 2024

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...

Approval Alert: Formycon’s Aflibercept Biosimilar Approved in US

Jun 28, 2024

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...