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60 Today's Veterinary Business Sponsored You, your team, and your clients have become familiar with certain brand-name drugs for patient care. And even though generic options exist, you and your clients hesitate to make the switch. What's the hesitancy? What are the common beliefs and misconceptions about veterinary brand-name drugs versus generic veterinary drugs? Test Your Knowledge of Generic Veterinary Drugs See how you score on these 5 facts about generic veterinary drugs. By Pam Foster for Today's Veterinary Business The main question is: Can generic veterinary drugs be significantly different than, or inferior to, the "pioneer" (brand name) drugs? In this informative quiz, you will test your knowledge about generic drugs versus brand name drugs and discover how generic drugs may help you and your clients save money on treatment, with the same safety and efficacy profile. Question 1: Pioneer (brand name) veterinary drugs go through more rigorous testing for approval than generic drugs do. Answer: False According to the ANADA process, the generic manufacturer must show that the generic drug is equivalent to the approved pioneer ("Brand") drug in: • Active Ingredient • Strength • Dosage regimen In addition… • Each ingredient must meet stringent quality standards • The generic drug must demonstrate stability over the shelf life of the product Question 2: Blood-level bioequivalence studies are required by the FDA-CVM for ANADA (Abbreviated New Animal Drug Application) approval, which establishes that any difference in the bioavailability between the generic and the pioneer drugs is considered clinically insignificant. Answer: True Blood-level bioequivalence studies compare a test product (generic drug) to a reference product (pioneer drug) using parameters measuring and encompassing: • Absorption • Distribution • Depletion of the drug concentration over time To determine bioequivalence, the generic sponsor completes blood level studies comparing its formulation vs. the pioneer formulation and reports to what extent the active ingredient concentrates in the blood and for how long. The average or mean results for the generic product must not be significantly different in comparison to the pioneer drug. Designing, conducting and analyzing a bioequivalence study can take as long as two to three years to complete. Below is a graph of a bioequivalence study results illustrating the mean blood concentrations of a pioneer drug (red line) and generic drug (blue line). Source: bpac, "What is Bioavailability and Bioequivalence?" – Generics 2009 Cmax = Maximum or Peak Concentration that a drug achieves in blood after the drug has been administered Tmax = Time at which the Cmax is observed AUC = Total area under the blood drug concentra- tion-time curve, or drug exposure over time. AUC is pro- portional to the total amount of drug absorbed by the body, and thus available to produce a therapeutic effect. Question 3: A generic veterinary drug can have up to 20% less active pharmaceutical ingredient (API). Answer: False To conduct the bioequivalence study, the same dosage is used for both the pioneer and generic formulations. The FDA-CVM considers two products bioequivalent if the mean Peak Concentration (Cmax) and Area Under the Curve (AUC) are not significantly different when applying a 90% Confidence Interval (CI) approach. The acceptable limits are that the generic product mean must be within 80%-120% (untransformed data) or 80%-125% (log-transformed data) of the mean of the reference product. This allows for individual animal variation in the live animal study. This does not mean that the generic drug is allowed to have 20% less active ingredient than the pioneer. Both products must be formulated to contain the same amount of active ingredient. Question 4: U.S. generic veterinary drugs are manufactured under identical quality standards as pioneer brands and in FDA inspected facilities. Answer: True Pioneer drugs and generic drugs must be manufactured to the same high quality standards of the FDA. Both are manufactured in FDA inspected facilities, must meet current "Good Manufacturing Practices" (cGMP) and must be shown to be safe and effective. Question 5: Generic veterinary drug manufacturers do not monitor their drugs for adverse events and quality complaints post-approval like pioneer brand manufacturers do. Answer: False FDA's Post Approval requirements for pioneer drugs and generic veterinary drugs are identical: • Pharmacovigilance (adverse event and quality complaint) monitoring and reporting • Reporting of manufacturing changes • Ongoing stability testing • Submission to FDA of advertis- ing and promotional materials Sponsored Content from Norbrook