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Amgen announces it has received FDA approval for Riabni® (biosimilar rituximab) for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis and Microscopic Polyangiitis. Riabni® will be launched in the US in January 2021...

The Centre for Biosimilars reports a new study indicates dramatically increased usage of trastuzumab biosimilars in the US. The study presented at the San Antonio Breast Cancer Symposium indicated that biosimilar use increased based on payer policies that favored biosimilar...

Samsung Bioepis announces it has commenced Ph III trials of SB16 (proposed denosumab biosimilar) in women with postmenopausal osteoporosis.

Biopharma supplier Alexion announces it will be acquired by AstraZeneca. The acquisition is expected to close in Q3 2021 for total consideration to Alexion shareholders of $39bn. Under the deal, AstraZeneca will acquire Alexion’s pipeline of 11 molecules, as well as A...

Innovent announces the first patient has been dosed in its Ph II trials of IBI310 (anti CTLA-4 monoclonal antibody) in combination with Tyvyt® (sintilimab) for the treatment of second-line or above advanced cervical cancer.

A new long-term efficacy and safety study demonstrated the biosimilarity of Celltrion’s CT-P10/Truxima® (infliximab) to Rituxan® at 27 months in patients with low-tumor burden follicular lymphoma.

Alvotech and Fuji Pharma announced they have agreed on an extension of their exclusive strategic partnership for the commercialisation of four biosimilar medicines in Japan.

MSD receives a positive opinion from the EU’s CHMP for an extended indication set for Keytruda® (pembrolizumab). If approved, Keytruda® will also be indicated for metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

Celltrion receives a positive opinion from the EU’s CHMP for its proposed 100mg/mL adalimumab biosimilar Yuflyma® for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psori...