Dr. Weber: Welcome to the CDER Small Business and Industry Assistance (SBIA) Chronicles Podcast.

Today’s topic: Insights about the FDA and EMA Parallel Scientific Advice Program for Complex Generic and Hybrid Drug Products.

My name is Dr. Ellicia Weber and today we are joined by Dr. Sarah Ibrahim, Associate Director of Stakeholder and Global Engagement for the Office of Generic Drugs in the Center for Drug Evaluation and Research at the FDA. Dr. Ibrahim is with us today to share insights about an ongoing pilot program that provides parallel scientific advice to applicants of abbreviated new drug applications for FDA’s complex generic drug products, and of marketing authorization applications for the European Medicines Agency (or EMA) hybrid products.

Thank you for joining us today Dr. Ibrahim!

Dr. Ibrahim: My pleasure!

Dr. Weber: Dr. Ibrahim, the generic drug pharmaceutical industry and the agencies that regulate them are increasingly seeking opportunities to proactively engage in the early stages of generic drug product development. Tell us how the Parallel Scientific Advice (also known as the PSA) pilot program can help.

Dr. Ibrahim: The PSA program allows for applicants to engage in concurrent scientific conversation with both agencies, the FDA and the EMA, on key issues during the development phase of complex generic drug products and hybrid products.

The EMA uses the term “hybrid medicines” for medicines whose authorization depends partly on the results of tests on the reference medicine and partly on new data, some of which can include what FDA defines as complex products. It allows prospective applicants of abbreviated new drug applications (or ANDAs) to FDA and marketing authorization applications (or MAAs) to EMA to submit a request for a meeting with both agencies to discuss specific questions regarding the development of complex generic drug or hybrid products.

So through the PSA process, ANDA applicants can gain an understanding of both agencies’ recommendations.

Dr. Weber: These complex generic drug or hybrid products – can you explain how they are more challenging to develop with traditional bioequivalence methods.

Dr. Ibrahim: Most definitely. Generally, complex generics are products that have complex active ingredients, formulations, dosage forms, or routes of administration, or are complex drug-device combination products. Generics of complex brand name drugs (or reference listed drugs) can be more difficult to develop. As such, a complex drug may be less likely to have an available generic. Through the PSA process, applicants would gain an understanding of both agencies’ recommendations. We highly encourage applicants to participate.

Dr. Weber: What benefits exactly will the pilot PSA program provide to the applicants?

Dr. Ibrahim: Well, for one, successful collaboration between FDA and EMA via the PSA program increases dialogue between the two agencies and optimizes the applicant’s global product development program by enabling them to discuss specific questions regarding complex generic drug products and hybrid products. It further provides applicants with a deeper understanding of the basis for regulatory decisions from both agencies, helping applicants avoid redundant replication of work and unnecessary testing replication or unnecessary diverse testing methodologies. And this in turn can shorten the time to approval. Participation in the PSA program is voluntary and initiated by the applicant, but it’s been a challenge to garner interest among applicants.

Dr. Weber: Why do you think that is?

Dr. Ibrahim:
Well, the program is new and we need to continue raising awareness to its existence and benefits to the generic drug development process. We evaluated the preliminary assessment of the PSA program to gain insight on how to advance participation, and want to ensure applicants that the program has already begun implementation of these recommendations.

The PSA program focuses on sharing information and perspectives. Following a PSA meeting, an applicant will have a clearer understanding of the agencies’ respective regulatory requirements and scientific recommendations regarding the development program discussed. If the advice from the two agencies is divergent, the applicant will have a clear understanding of the reasons for divergence.

Candidates for the PSA program may use the Program to determine whether a study design, or designs, might be acceptable to both regulatory agencies including comparative non-clinical and comparative clinical studies involving innovative bioequivalence study designs and the use of methodologies such as modeling and simulation.

For each approved PSA request, the agencies will hold one trilateral meeting with the applicant focused on the specific development issues raised.

Dr. Weber: This sounds like a win-win! And to clarify, this is an expansion of the FDA and EMA’s existing PSA projects for new drugs and biological products, and it seems that participation is not a complicated process.

Dr. Ibrahim: Yes. We really want to encourage applicants to participate. Industry can request PSA meetings for complex generic drugs and hybrid products by sending a single “Request for PSA” justification letter to both EMA at emainternational@ema.europa.eu and FDA at preANDAHelp@fda.hhs.gov to initiate the PSA process.

Dr. Weber: How long is the pilot program?

Dr. Ibrahim: Meeting requests will be received until FDA and EMA determine the number of completed PSA meetings is sufficient to assess the pilot program. During and after conclusion of the pilot, each agency will evaluate the benefits and challenges of the program, including the resources required, and determine next steps.

Dr. Weber: Thank you Dr. Ibrahim for your time today! Do you have any last thoughts you would like to share with our listeners?

Dr. Ibrahim: Sure! With today’s global market, I just want to reiterate how helpful this program is for applicants and patients, and to encourage applicants to participate. Not only will participation increase dialogue among the two agencies and applicants from the beginning of the lifecycle of a complex generic drug product, but it will provide a deeper understanding of the basis of regulatory decisions, optimize product development, and avoid unnecessary replication of studies or unnecessary diverse testing methodologies.

Achieving harmonization and increased convergence are potential benefits of the PSA program, ultimately serving patients globally.

Dr. Weber: Thank you Dr. Ibrahim!

You can find a link to the full SBIA Chronicles article at www.fda.gov/cdersbiachronicles. Also visit www.fda.gov/cdersbia to stay connected with upcoming webinars and conferences, sign up for SBIA email updates, and follow SBIA on LinkedIn. Thanks for tuning in!

Resources:

FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products | FDA