New biosimilar pathway paves way for US approvals

Biosimilars pathway_0

With the recent announcement that the FDA has accepted its first biologics license application (BLA) for a biosimilar version of filgrastim, many stakeholders are wondering how the drug will affect formulary decision making and drug costs. Sandoz’s BLA for filgrastim (granulocyte colony-stimulating factor) will be the test case for the FDA’s new biosimilar approval pathway, giving the U.S. market access to these products. The pathway to US approval of biosimilars will be stringent and will require highly sophisticated and sensitive analytical data to compare the biosimilar product with the reference version. The purpose of these stringent requirements is to ensure that newly approved biosimilars will perform as well as the reference product.

Read the source article at Clinical Oncology News

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