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

Pharma in Brief

FEBRUARY 8, 2024

For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”. Dormant status: A drug listed as “Dormant” in Health Canada’s Drug Product Database means the drug is not presently being sold in Canada, but has not been withdrawn from the market. b) of the Regulations.

Production

Production Generic Drugs Bioequivalency Drugs

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

FEBRUARY 8, 2021

As biologics have the reputation of being expensive due to their complex nature and production, biosimilars have the ability to improve market access to patients and payors who would otherwise be unable to afford these drugs. To date, the FDA has approved 29 biosimilars, 19 of which are currently being marketed.

Production

Production Insulin Branding Generic Drugs

Clinical Research Informer

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

Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

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