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Cost savings from the use of biosimilars in Canada Biosimilars/Research | Posted 27/03/2020

Analysis of the potential cost savings from the use of three biosimilars (filgrastim, infliximab and insulin glargine) in Canada shows that over CA$1 billion could have been saved in just a two-yea...

FDA to transition NDAs to BLAs Guidelines | Posted 27/03/2020

The US Food and Drug Administration (FDA) is soon to transition many new drug applications (NDAs) to biologicals license applications (BLAs), with significant implications for biotechnology compani...

Denosumab copy biological accepted for review in China Biosimilars/News | Posted 27/03/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for the approval of denosumab copy biological HLX14.

Generics outreach programmes should target high income groups Generics/Research | Posted 27/03/2020

Patients with lower incomes are more likely to use generic drugs, finds a literature review from Auburn University, Alabama, USA [1].

Roche continues litigation in India and receives fine in Romania Pharma News | Posted 27/03/2020

Switzerland-based pharmaceutical giant Roche is continuing to pursue legal action in India over a trastuzumab similar biologic and has recently been fined in Romania for delaying the entry of biosi...

Celltrion/Teva launch trastuzumab biosimilar Herzuma in US Biosimilars/News | Posted 27/03/2020

Celltrion and Teva announced in March 2020 that they have launched their trastuzumab biosimilar Herzuma (trastuzumab-pkrb) in the US. Herzuma can be used to treat breast and gastric cancer and has...

Clover starts phase III trial for etanercept copy biological in China Biosimilars/Research | Posted 27/03/2020

At the end of December 2019, Clover Biopharmaceuticals (Clover), a Chinese company focused on biological therapies, announced the start of a phase III trial of their etanercept copy biological (SCB...

US oncologist says Medicare should not practice medicine Biosimilars/General | Posted 27/03/2020

Clinical oncologist, Dr Debra Patt, who serves on the US Oncology Research Breast Cancer Committee and chairs the breast cancer subsection of the pathways task force for The US Oncology Network, ex...