Pharma in Brief
FEBRUARY 8, 2024
On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.
Drug Discovery World
AUGUST 22, 2023
Claire D’Abreau-Hayling, Chief Scientific Officer at Sandoz, examines how generic products can relieve industry pressure and improve access to essential medicines. Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost. What are complex generics?
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FDA Law Blog
MARCH 5, 2023
Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. As part of its Generic Drug User Fee Amendments of 2022 (“GDUFA III”) Commitment, FDA agreed to expedited development of PSGs.
Camargo
NOVEMBER 11, 2020
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.
Pharmaceutical Technology
OCTOBER 28, 2022
According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.
XTalks
FEBRUARY 8, 2021
While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?
FDA Law Blog
FEBRUARY 26, 2024
Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”
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