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Innovent announced China’s NMPA has approved Byvasda® (biosimilar bevacizumab) for the additional indication of adult recurrent glioblastoma.

Biocon announced that its subsidiary Biocon Biologics has been informed by the FDA of a deferred action on the BLA for its proposed bevacizumab biosimilar. This deferral was attributed to COVID-19, as the FDA was unable to conduct the required inspection of the manufacturin...

The Centre for Biosimilars interviews Christophe Bourdon, senior VP and general manager of US Oncology at Amgen following FDA approval of Riabni® (biosimilar rituximab). Bourdon stated that Riabni® will be made available through speciality and wholesale distribution, and th...

Roche announces results for its investigational bispecific antibody faricimab in patients with diabetic macular edema. Roche announced that the candidate was generally well-tolerated with no new safety signals identified. This product is being developed as a replacement for...

Bio-Thera Solutions announces it has reached a licensing agreement with Biomm SA for BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Biomm will have exclusive rights to distribute and market the drug in Brazil. Bio-Thera has filed license applications for BA...

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...