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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Camargo

NOVEMBER 11, 2020

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. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

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Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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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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XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

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Pharmaceutical Technology

JULY 25, 2022

Specialty generics is a term used to refer to generic versions of drugs that are often expensive, complex, or “high touch”—requiring significant involvement of service to manage. Specialty drugs are most used to treat different cancers, rheumatoid arthritis, and multiple sclerosis. But there are some exceptions.

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Delveinsight

FEBRUARY 5, 2021

Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market? The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Generics in the Market.

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