Providing high-quality yet affordable patient care is a goal for veterinarians, especially with today's economy. The cost of treating pets often plays a large part in how clients perceive the value of their veterinary care.1 Generic drugs are an attractive option with attributes of both affordability and quality; however, these drugs can raise questions about how their efficacy and safety compare with that of their brand-name counterparts. The fact is both brand-name and generic drugs, whether they are intended for human or veterinary use, undergo a stringent approval process overseen by the U.S. Food and Drug Administration (FDA).
What's the difference between brand-name and generic drugs?
A brand-name (pioneer) drug is sold and manufactured under a trademarked name by a pharmaceutical company that holds the drug patent. These drugs include prescription products that undergo many extensive clinical efficacy and safety tests and are often backed by large marketing campaigns, all of which contribute to their higher costs.
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In anticipation of a drug company's patent and marketing rights expiring for a pioneer drug, other drug companies may begin an application and review process with the FDA to manufacture a generic formulation of the drug. The FDA review process for generic drugs is similar to the review process for brand-name drugs (Table 1). However, generic drug companies are not required to repeat clinical efficacy and safety studies since these have already been conducted for the pioneer drug. Instead, generic drug manufacturers must demonstrate that their product is bioequivalent — that the generic drug delivers the same amount of active ingredient to the site of action as the pioneer drug and produces the same physiological results.
Table 1: Brand-name vs. Generic vs. Compounded Veterinary Drugs
Like their brand-name counterparts, generic drugs must be manufactured in accordance with current Good Manufacturing Practices (cGMP) in order to receive FDA approval. The manufacturing facilities for generic and pioneer drugs can be domestic or overseas and, as with pioneer drugs, generic drug manufacturing facilities must be inspected and accepted by the FDA. The generic drug company must also demonstrate that their product has the same strength, purity, and quality as that of the pioneer drug. Stability data must be provided for generic drugs to ensure that the drug has the intended shelf-life with no loss of potency.
By showing that the generic drug is bioequivalent to the pioneer drug, it's expected that the risk of side effects for the generic drug is comparable to that of the pioneer drug. As with brand-name drugs, the FDA continues to monitor reporting of adverse drug reactions for generic drugs once they are on the market.