New developments in FDA regulations for complex generic drugs

Since the promulgation of the Hatch-Waxman Act ("Drug Price Competition and Patent Term Compensation Act") in 1984, the US FDA has formulated a number of policies aimed at accelerating the launch of generic drugs in order to promote drug competition and increase the availability of drugs to the public.

Definition of complex generic drugs

According to the definition described in the FDA's GDUFAII ("Generic Drug Filer Pays Act") commitment letter, complex products-generally include the following situations:

1.

2.

3.

For these complex generic drugs, due to their complex formulations and active ingredients, it is generally difficult to "generate" using traditional biological equivalence methods (such as their formulations or drug delivery systems), so the number of them is small, leading to the market for these products There is also less competition.

FDA's advancement of complex generic drugs

On the one hand, the FDA has issued a series of specific product (PSG) guidelines.

In addition, in order to pay special attention to complex generic drugs, the FDA has opened up a new webpage for complex generic drugs PSG-the upcoming Upcoming Product-Specific Guidances for Complex Generic Drug Product Development (Figure) 1) When the FDA releases PSG batches every quarter, the web page will be updated once.

On the other hand, the FDA established the pre-ANDA program (pre-ANDA program) in accordance with the 2017 Generic Drug User Fee Amendment Act (GDUFA II).

On August 1, 2020, the FDA granted the University of Maryland and the University of Michigan a 5-year (August 1, 2020 to July 31, 2025) grant to establish the Center for Research on Complex Generics (CRCG).

On May 19, 2021, the FDA issued the second batch of 21 specific product guidelines (PSG) this year, including the complex products fluticasone furoate; umelonium bromide; vilanterol inhalation powder (RLD: TRELEGY ELLIPTA), mida Guidelines for zolam nasal spray (RLD: NAYZILAM), methacrylamide metered nasal spray (RLD: GIMOTI), and intravenous meloxicam solution (RLD: ANJESO).

Case Analysis of Complex Generic Drugs

Below we use several sets of data and cases to understand the specific situation of complex generic drugs:

At the beginning of 2021, at the "Complex Generic Drugs and Prescription Drug Landscape" webinar hosted by the American media The Hill and sponsored by the AAM (AAM), attendees mentioned in their speech materials the approval status of complex generic drugs outside the U.

In addition, from the generic drug annual reports issued by the FDA Office of Generic Drugs (OGD) in recent years, we can see that in 2018, the FDA approved or temporarily approved 1,021 new drug simplification applications (ANDAs), of which complex generic drugs accounted for 14%; 2019 In total, 1,014 generic drugs received final and preliminary approvals.

Some of the complex generic drugs that are worthy of attention approved by OGD in fiscal 2021 include the following:

to sum up

Although the US generic drug market is not profitable for latecomers, the status quo is not the case for generic companies of complex generic drugs.

Reference materials:

1-FDA official website

2- The review and policy priorities summarized at the FDA 2021 Generic Drug Forum

3- "Alex Brill, Potential Savings from Accelerating US Approval of Complex Generics"