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Experts ask industry to request US govt to expedite generic approvals having established BE in other jurisdictions
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Shardul Nautiyal, Mumbai
July 25 , 2023
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Regulatory experts have recommended to the Indian pharma industry to bring to the US government’s notice the significant time taken for generic drug approvals and request expedited approvals in cases of product having established bioequivalence (BE) in other jurisdictions. This will give boost to India’s pharma trade and exports.
Depending on the complexity of the drug and completeness of application, the US FDA approval process may take any time between 6 months to several years. The Indian government should emphasize the need for the US FDA to consider a more liberal approach to determining bioequivalence between the claimed generic products and the listed drugs.
In order to get a generic drug approved, a drug developer must apply for an Abbreviated New Drug Application (ANDA) approval. There are two types of ANDA approval. First one is called Full Approval. The US FDA may grant Full Approval if all valid patents and exclusivities for the reference listed drug have expired. Further, all legal issues that may block the approval of the ANDA must have been settled.
The second one is called Tentative Approval. A Tentative Approval is granted when the US FDA concludes that a drug product has met all required quality, safety, and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States.
An application to the US FDA may be filed under Section 505(j)(10) of the FD&C Act. The application must contain information to show that the conditions of use prescribed, recommended, or suggested in the labelling proposed for the new drug have previously been approved for a listed drug. Similarly, it must also contain information demonstrating that the route of administration, the dosage form, and the strength of the new drug are the same as the listed drug. The bioequivalence of the listed drug and the new drug must be demonstrated, along with information concerning the active ingredient(s) present in the new drug and the corresponding listed drug.
The application must be supplemented with patent information of the listed drug. The applicant is required to provide a certification for each patent listed in the Orange Book for the listed drug. The certification is required to state one of the following: Required patent information relating to such patent has not been filed; Such patent has expired; Patent will expire on a particular date; or Such patent is invalid or will not be infringed by the drug for which approval is being sought.
In the event that the applicant claims that the patent is invalid or will not be infringed by the new generic drug, a litigation process starts wherein the courts are required to determine the validity of the applicant’s claim before the expiration of the patent. The first applicant to file a substantially complete ANDA containing a certification with such claim will be eligible for a 180-day period of exclusivity.
After review, an Acceptance/Refuse to Receive (RTR) letter is issued based on the completeness of the ANDA. If all the information submitted by the applicant is acceptable, the Office of Generic Drugs issues market approval.
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