Celltrion announces Ph III trials of its proposed ustekinumab biosimilar CT-P43 will be completed by the second half of 2022. Celltrion also announced plans to launch the product when the API patents expire in the EU in September 2023 and in the US in July 2024.
Samsung Bioepis released a Whitepaper ‘Education in Biosimilars’ which identifies fundamental information gaps and unmet needs in the biosimilar space. Among the key conclusions reached by the report was the need to ensure nurses are properly trained and educate...
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...
24 Nov 20 | Novartis released its annual report ‘Meet Novartis Management 2020’. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced...
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.
Pearce IP publishes free e-books addressing various aspects of patent law and practice in Australia, with a focus on issues affecting pharmaceutical, biopharmaceutical and other life sciences companies.
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