There are different types of generic pharmaceuticals meeting various patients’ medical needs. Some treat rare diseases such as the prescription only injection of zoledronic acid used to prevent fractures in patients with prostate cancer or multiple myeloma.
Others such as acetaminophen treat common disease such as pain. Not all diseases have an equivalent generic pharmaceutical. Generic drugs are cheaper than the original brand name drugs.
Many consumers feel relieved when a generic drug comes into the market. They can get a price reduction sometimes up to 80%.
Most people are not aware of the generic version until they are alerted by their family doctors or pharmacists.
In some cases a person may have to wait for a long time to see a generic in the market because of patent protection.
For example in 2015, the FDA approved over 40 new innovative drugs. Its not easy to predict when generic drugs will be available in the market.
In December 2015 the public was surprised and upset to read in the press of the generic pharmaceuticals review delays. About t 4,300 generic drugs were waiting for approval.
The question most people were asking was, Why the delay?
To answer this question we have to understand what happens when a pharmaceutical company submits an application to the FDA for approval. Different companies made different errors of omission.
Patent problems and delays of reviews: generic pharmaceuticals
Patents are very important for generic drug companies as well as innovator companies. Without a patent or reference to an expired patent, a pharmaceutical company will not get a dug approved for marketing.
If a pharmaceutical company lacks this knowledge, it would appear to be in the wrong business. It must have personnel who will be able to notice this deficiency very early.
The FDA will not approve a generic drug to be marketed if the referenced patent is being contested in court. Faults in patent information are common causes of generic pharmaceuticals review. We can organize an in house course to help your company. Contact us. Your staff can also take an appropriate online course.
Evidence that the generic had passed the test
The generic drug must be tested where possible in healthy people to proof that it’s a therapeutic equivalence to the brand name drug.
After the test, data is evaluated by pharmacologists and other experts to ensure that it meets all the regulatory requirements.
Failure to provide relevant data of high quality results in the rejection of the application or a delay of the review. This is a common cause of generic pharmaceuticals review. Some companies may take this process lightly only to be shocked when the application is rejected.
Quality of the generic
The development of the generic drug must demonstrate high standards of the formulation. Regulators want to see Quality by Design (QbD) approach.
Regulators now want to see QbD in developing a generic drug product formulation. This is expected to provide evidence for a rational formulation and manufacturing process which should ensure the, safety, efficacy and quality of the product.
A deficiency in providing appropriate quality information to the regulatory agencies is another common cause for delays in the review of generic pharmaceuticals.
