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Roche published its Q1 2021 earnings report, noting significant impacts from biosimilars. In particular, Roche attributed a combined sales reduction of CHF 1.6 billion to the impact of rituximab, bevacizumab and trastuzumab biosimilars.

Luye Pharma announced its marketing authorisation application for LY01008 (proposed bevacizumab biosimilar) has been accepted by China’s National Medical Products Administration.

Huons Lab announced it has reached an agreement with PanGen Biotech for the development of biosimilar denosumab. Under the agreement, Huons Lab will gain access to PanGen Biotech’s cell line manufacturing and purification technology.

Prestige Biopharma and Pharmapark announced they have reached an agreement for the commercialisation of Prestige Biopharma’s proposed bevacizumab biosimilar in the Russian Federation.

Shanghai Henlius Biotech announced China’s NMPA has approved its investigational new drug (IND) application of its HLX26 (recombinant anti-LAG-3 human monoclonal antibody) for treatment of solid tumors and lymphomas. Currently, there are no LAG-3 targeted products on ...

The Centre for Biosimilars reported a poster presented at AMCP 2021 shows a New York state Medicaid biosimilar preference initiative was successful in increasing biosimilar use in 2019. Biosimilar substitution is not permitted at the pharmacy level in New York, and provider...

Two bills aimed at lowering the cost of prescriptions were passed by the House of Representatives. As we previously reported, the Advancing Education on Biosimilars Act and Ensuring Innovation Act were introduced to the Senate in March 2021.

NKMax and Merck KGaA announced an expansion of its clinical trial and supply agreement to include a Ph I/IIa trial of SNK01 in combination with Erbitux® (cetuximab) in patients with locally advanced or metastatic non-small cell lung cancer.

Purple Biotech announced it presented further preclinical data supporting the mechanism of action of NT219 at the American Association of Cancer Research 2021 Annual Meeting. NT219 is being developed as a treatment for recurrent and/or metastatic solid tumors and squamous c...