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Dormant drug status can trigger generic access to an alternate Canadian Reference Product

Pharma in Brief

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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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

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 “genericdrugs of the biopharma world.

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The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

Delveinsight

The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Moreover, the generic drugs of Zyban are also approved, while for Chantix, its patent is soon going to expire in 2021 in the EU and in 2022 in Japan. Generics in the Market.