From time to time, the Food and Drug Administration (FDA) offers a lot of updates to its materials and practices, and any person involved with the industry needs to stay alert for new releases, educational events, and training. This can focus on highly specific topics that are especially important for investigators, clinical personnel, sponsors, and individuals that are otherwise engaged in the pharmaceutical industry. One aspect of this is the need to keep up with updates and changes that the FDA makes to ensure better results, high-quality data, and a smooth approval process for all kinds of drugs. FDA has focused especially on changing and improving the process associated with generic drugs that are highly important for public health.
In 2021, FDA revised the draft guidance for Bioequivalence (BE) Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA; providing an update to the current recommendations, assistance to ANDA applicants and supplements, and, overall, to support the patients’ access to lower cost and high-quality medications and drugs. (1)
What is ANDA? ANDA stands for Abbreviated New Drug Application, and it involves submission to FDA for a new drug. Last month, (February 24, 2022), the FDA hosted a webinar titled Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA to discuss agency thinking on some other points and answered questions related to this updated and the revised guidance.
It is worth noting the previous guidelines came out in 2013, which signifies a big shift in the process. The webinar is a must for people involved in the generic drug industry, current applicants and potential applicants, regulatory reviewers, and policymakers. The webinar is a more specialized topic with a wide reach thanks to the focus on generic drugs, as bioequivalence studies most commonly are associated with the possibility of releasing more generics. (1)
In order to understand what this centers on, it is important to understand what bioequivalence is. Bioequivalence study with pharmacokinetic endpoints of a drug product is essential for ANDA and the improvement of pharmaceutical readiness in the pharmaceutical business. (2) It is usually used to establish similarity between a generic drug and a reference drug, which leads to establishing if there are no significant differences in the availability of the active ingredient at the site of action of the drug. (3) Furthermore, bioequivalence studies are very important to expand the use of nonspecific medications, reduce the costs for the patients and users, which has a big impact on public health but also on the pharmaceutical industry gain access to FDA support and fast approval and market release. (4)
So, what are some of the major changes associated with the 2021 revision of the guidelines? Firstly, it updates and clarifies content on Reference Listed Drug (RLD) and Reference Standard (RS) in the Orange Book, clarifying the difference between the two and their application. The second major change involves an expansion in regards to sex (male/female), age (pediatric and elderly)， and other sociodemographic characteristics. For instance, studies should justify the use of a single-sex study sample or include comparable samples of men and women. This was introduced due to studies that did research on single-sex samples for products meant to be used with men and women both. The guidelines also suggest using more participants over 60 for drugs meant to be used by the elderly and justify pediatric use if the study was carried out with adults only. Another change involves demonstrating additional strengths for modified-release drug products based on the mechanism of release and dissolution profile similarity. The guidelines add new sections on other dosage forms, such as sublingual or transdermal, and adds a section on alternative forms of administration, such as a nasogastric tube. There are new sections on handling outliers and a section in the appendixes for highly variable drugs and their scaled average BE analyses. It also removes the section of Orally Administered Drugs Intended for Local Action from...
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