We promise we’re not just putting “bio” in front of words. Bioavailability is referred to as the extent and rate to which the API from the drug product is absorbed and becomes available at the site of drug action. For two products to be bioequivalent they must exhibit the same bioavailability.
Bioequivalence – Different but the Same
What is Bioequivalence?
Bioequivalence is a measure of how closely different drugs with the same active ingredient trigger the desired biochemical pathways and produce the same clinical effects on patients. It implies that different drugs are of comparable quality and release their active ingredient in the equivalent dose and at the same rate of absorption.
Bioavailability
Drug concentration vs. time curve
Reflects the amount of API that has reached circulation for a drug.
Achieving Bioequivalence
Bioequivalence doesn't require the full clinical trial process that brand products must go through. To be bioequivalent, the following steps must be performed:
Test the generic/alternate drug against the brand-name drug on two small groups of test subjects.
Draw timed blood samples from each patient.
Demonstrate through statistical analysis that any difference in the drug’s bioavailability in participants is not clinically significant.
It is easier to make a bioequivalent form of a traditional pill or injectable than to make a bioequivalent form of a biologic. Be on the lookout for a future FSF to find out why!
Understanding Bioequivalence
Bioequivalence, according to the FDA, is when two products are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action. The two drugs must also have the same (or nearly identical) dosing and similar conditions to be able to compare and approve the two for bioequivalence.
For a generic or alternative drug to be bioequivalent to a brand or original version, the drug manufacturer must demonstrate it is pharmaceutically equal to the brand version. A drug maker must also get FDA approval before marketing or selling a different version of an approved drug. For example, it must prove a once-a-week tablet is bioequivalent to a daily tablet. In addition, the FDA has different bioequivalence standards depending on whether the drug is taken as a pill, injection, patch, inhaler, or through another method. When a generic or alternate drug is not bioequivalent to the brand version, it may still be approved for another use, but not be approved as a substitute.
Drug concentration vs. time curve
Test/Generic drug demonstrates nearly identical bioavailability as brand.
Bioequivalence in Industry & AbbVie
Bioequivalence isn’t exclusive to comparing the same products made by different companies, but also used in the context of describing if multiples of one dosage form are bioequivalent to another as well as if two different delivery mechanisms are bioequivalent.
Bioequivalence & Generics
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.
Not to be confused with Authorized Generic (AG), which is most used to describe an approved brand name drug that is marketed without the brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the branded product. Abbvie supports authorized generics in order to support patient access by helping patients adhere to high-quality affordable medicines, and support operations with maximizing manufacturing capacity.
