Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite ...

It has been 10 years since the first biosimilar was approved by the FDA. The grades on how the market for biosimilars has ...

Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 ...

Health Canada has granted approval to Nora Pharma for the commercialisation of its first biosimilar product, Niopeg (a pegylated form of filgrastim). The Niopeg is comparable to the reference ...

Biosimilars, copies of off-patent biopharmaceuticals ... a pegylated form of the granulocyte colony-stimulating factor analog filgrastim, which mitigates the negative effects of chemotherapy ...

Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number of FDA-approved biosimilars to 63. Forty-one of those biosimilars have ...

Earlier this month, the European Medicines Agency (EMA) recommended marketing authorization for Zefylti, a filgrastim biosimilar developed by CuraTeQ Biologics. In another development, Aurobindo ...