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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 β€œthe pharmaceutical equivalent of the [CRP]” and be β€œbioequivalent with the [CRP]”.

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

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Biosimilars vs. Interchangeable Biological Products: FDA Fact Check

XTalks

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 β€œgeneric” drugs of the biopharma world. What is a Biosimilar?

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When FDA-Approved Generics Fail: Brand Wellbutrin XL Antidepressant is Cheaper from Canada

Pharmacy Checkers

In fact, they asked ConsumerLab.com, sister company to PharmacyChecker, to test the product. Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. pharmacies is manufactured and sold in Canada as well. Comparing Wellbutrin XL Costs & Manufacturing in the U.S.

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Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

The Pharma Data

Food and Drug Administration (β€œFDA”) has approved its Abbreviated New Drug Application (β€œANDA”) for Glucagon for Injection Emergency Kit, 1 mg. This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.”

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Jailed pharma exec fined Β£47m and banned from industry

pharmaphorum

The company was slammed for restricting distribution of its drug so generic drug manufacturers couldn’t conduct bioequivalence tests or access a key ingredient used in the drug’s production.

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Do generics producers have what it takes to tackle complex and specialty drugs?

Pharmaceutical Technology

With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Specialty generics is a term used to refer to generic versions of drugs that are often expensive, complex, or β€œhigh touch”—requiring significant involvement of service to manage.

Drugs 298