Do generic medicines work the same?

Generic medicines work the same as brand-name medicines A generic medicine is required to be the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken. Generic medicines also have the same risks and benefits as their brand-name counterparts.

How is medicine defined in NZ?

Medicine – means any substance or article that – is manufactured, imported, sold, or supplied wholly or principally for administering to 1 or more human beings for a therapeutic purpose; and.

When is bioequivalence required?

Bioavailability and bioequivalence studies are required to ensure therapeutic equivalence between a pharmaceutically equivalent test drug and a generic drug or reference drug.

What is a generic medication name?

While brand name drug refers to the name giving by the producing company, generic drug refers to a drug produced after the active ingredient of the brand name drug. Generic drugs will, however, be sold under different brand names, but will contain the same active ingredients as the brand-name drug.

Which is better generic or branded medicine?

Generic medications must meet the same quality, strength, and purity standards as brands, so they have the same benefits and effects. Brands and generics don’t look exactly alike (color, size, shape, packaging), but they work the same. Generic medications cost a lot less than brand names.

What are controlled drugs NZ?

Controlled drugs include medicines available on prescription from a health professional. Prescribing of controlled drugs is more tightly controlled than prescribing of other medicines, reflecting the need to restrict access to, and minimise the misuse of, controlled drugs.

Why is a generic or Inn name used rather than using trade names for medicines?

New Zealand is a small market and due to economy of scale, the medicines supplied here are often batches of product produced or packaged for a larger or international market. If that other market is in a country that requires medicines to be labelled as INNs, then NZ is likely to receive INN-labelled medicines.

Are generics bioequivalent?

In addition to being pharmaceutically equivalent, generic drugs must also be “bioequivalent” to the brand name drug. That means the generic drug will work in the body in the same way (same amount goes into the body within the same time frame) and be as safe and effective as the brand name drug.

What criteria determine bioequivalence of drugs?

For oral drugs, bioequivalence is determined by comparing the relative bioavailability of the brand name drug versus the generic drug. There must be no more than a 20% difference between the AUC and Cmax of brand name versus generic products.