Understanding the Generic Drug Approvals Process
Getting generic drugs approved and on the market is a complex process that can be lengthy, but the thoroughness of the review process ensures only high-quality, safe, and effective medications are available to patients and consumers.
While branded drugs prove their effectiveness to the FDA via their research, development and clinical trials, generic drugs demonstrate their effectiveness with data that shows the drug can be an appropriate substitute for the branded product.
As the regulatory body for branded and generic drugs, the FDA’s job is to review data provided by generic manufacturers to ensure they prove the substitution ability of their generic drug.
It takes a dedicated manufacturer like Westminster Pharmaceuticals to ensure we provide full and complete data and see the review process through until approval is finally received. Learn more about the approvals process from the manufacturer’s end and the FDA’s role.
The Data
The data provided on the approval application by the manufacturer is the basis of the review.
The goal is multi-fold:
Prove the active ingredients are the same
Prove the amount of the active ingredients are the same
Prove the active ingredient works in the same place and way in the body
Prove the inactive ingredients are safe
Prove the product can be produced consistently
To do this, the FDA looks for information showing the manufacturing process. This should include how the generic drug is made using active plus inactive ingredients to reliably make a high-quality product.
They also need information that proves the medications have the same effect. The way a manufacturer proves this may vary, but usually, the FDA requires studies with human volunteers taking both branded and generic versions of the drug to prove the product behaves the same way in patients. An appropriate generic drug should be able to substitute a branded drug on any day and provide the same treatment effect.
Review
Once a manufacturer submits their complete application with the information above, the FDA begins the involved review process. Immediately, the FDA will examine the data submitted and any information gathered from testing or manufacturing facility inspections to ensure the application proves the drug is a substitute for an already-approved brand-name drug.
On an ongoing basis, the FDA will also make periodic inspections of manufacturing plants and monitor drug quality. If a generic manufacturer ever wants to change a drug, they’ll need to get new approval before any modified drugs can be released to patients.
Common Questions About Generic Drug Approvals
Why aren’t generics available immediately after a brand-name drug is approved?
Branded drugs receive exclusivity to allow them to recoup the research and development costs for the drug. Most brand drugs have an exclusivity window between 3-5 years. After exclusivity ends, generics can apply to join the market. However, the first generic drug applicant usually has an additional 180-day exclusivity window before others may be released.
How long does it take from application submission to get approval?
It depends on how complete the application is and complex the drug is. Some drugs are prioritized by the FDA’s Center for Drug Evaluation and Research due to their importance to public health and may receive approval in < 6 months. Others may require several application revisions and review cycles before meeting the FDA’s rigorous standards for approval. Complex products such as injector pens, inhaled drugs or topical drugs may take longer to approve.
Can manufacturers reduce approval times?
While you can’t guarantee a faster approval, a manufacturer can increase their odds of approval from the first application by studying FDA guidance, including product-specific guidances, before developing a product or submitting an application. Manufacturers can also request a meeting with FDA to ask questions during development or application review.
The Right Manufacturer Makes a Difference
When it comes to generic drug approvals, the right manufacturer can make all the difference between an approval the first time and a drawn-out process of multiple review cycles. Experienced generics manufacturers like WPRX are familiar with submitting ANDAs and know what the FDA is looking for to approve a generic drug.
Our expertise in the generics field allows us to anticipate any challenges in approval and troubleshoot in advance to ensure applications don’t get held up due to required revisions. This ensures we can quickly bring our safe, effective, and affordable generics to market and get them into the hands of the patients and consumers who need them as soon as possible.
If you’re looking for a dedicated partner to help bring your generic drugs to market, reach out to Westminster Pharmaceuticals to learn more.