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Kodak Pharmaceutical deal under scrutiny Pharma News | Posted 11/09/2020

In late July 2020, US President Donald Trump announced that the Federal Government would be loaning Eastman Kodak Co US$765 million to develop generic drugs. This is the first loan to be granted un...

EC approval for trastuzumab biosimilar Zercepac Biosimilars/News | Posted 04/09/2020

The European Commission (EC) has granted marketing authorization for the trastuzumab biosimilar Zercepac (HLX02) on 27 July 2020. The product is produced by the Shanghai Henlius Biopharmaceutical C...

Center for Biologics Evaluation and Research to regulate biological master files Guidelines | Posted 04/09/2020

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is now responsible for administering master files for biological drugs, which could create some chall...

WHO prequalifies Celltrion’s trastuzumab biosimilar Herzuma Biosimilars/General | Posted 04/09/2020

The World Health Organization (WHO) has prequalified Celltrion Healthcare’s second biosimilar, a trastuzumab biosimilar sold as Herzuma.

Bio-Thera partners with Pharmapark to market golimumab biosimilar in Russia and other CIS countries Pharma News | Posted 04/09/2020

China-based biopharmaceutical company Bio-Thera Solutions (Bio-Thera) announced on 18 July 2020 that it has signed a licensing agreement for its proposed golimumab biosimilar BAT2506 with Russia-ba...

Solutions to US low biosimilars uptake Policies & Legislation | Posted 04/09/2020

The uptake of biosimilars in the US has been lower than projected. Researchers at the UNC Eshelman School of Pharmacy in the US, have published a policy brief that identifies the main barriers to b...

Biosimilar infliximab could save Canada over CA$2 million by 2021 Reports | Posted 04/09/2020

Estimates for the potential savings from the use of infliximab biosimilars in Canada suggests that savings by 2021 could be between CA$447 million and CA$2,310 million, depending on the level of up...

Monoclonal antibody biosimilars and cancer in the EU Biosimilars/Research | Posted 04/09/2020

Spanish researchers investigated the current status of biosimilar monoclonal antibodies (mAbs) in the European Union (EU) by reviewing the regulatory pathway, the rationale for extrapolation and sw...