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]”.

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Production Generic Drugs Bioequivalency Drugs 52

Delveinsight

FEBRUARY 5, 2021

The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Rather, the bioequivalence studies were performed using the 150 mg strength; and the data was extrapolated to the higher dose. Quitting smoking is an arduous, exhausting process. However, it is possible.

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Marketing FDA Approval Branding Production 52

XTalks

FEBRUARY 8, 2021

While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.

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Production Insulin Branding Generic Drugs 78