Complex Generic Drug Products
Complex Generic Drug Products? In GDUFA II, the US FDA says to use the Pre-ANDA Program, which is the 505(b)(2) process. The experts in 505(b)(2) drug development can help!
The new Pre-ANDA program aims to prevent multiple review cycles and refuse-to-receive letters, which are inefficient and costly, and lead to a substantial amount of re‑work for both the Agency and applicants. In GDUFA II, the new guidance, the FDA is introducing Pre-ANDA meetings to help align complex generic products for success before the ANDA application is filed.
What Are Complex Generic Products?
The FDA defines complex generic drug products as:
- “Products with complex active ingredients (e.g., peptides, polymeric compounds, complex mixtures of [active pharmaceutical ingredients], naturally sourced ingredients); complex formulations (e.g., liposomes, colloids); complex routes of delivery (e.g., locally acting drugs such as dermatological products and complex ophthalmological products and otic dosage forms that are formulated as suspensions, emulsions, or gels); or complex dosage forms (e.g., transdermals, metered dose inhalers, extended-release injectables);
- Complex drug-device combination products (e.g., auto-injectors, metered dose inhalers); and
- Other products where complexity or uncertainty concerning the approval pathway or possible alternative approach would benefit from early scientific engagement.”
Historically, complex generic drug products have been viewed as more difficult to “genericize” and therefore face less or no generic competition in the market after approval. Unlike traditional generic products, complex generics products require early flexible interaction with the FDA, creativity in identifying new strategies, and regulatory agreement on a less defined development path. These are the same tenets that make the 505(b)(2) an innovative and adaptive pathway for product approval. Thus, the FDA is implementing pre-ANDA meetings for complex generic products.
Pre-ANDA Meetings and GDUFA II
The FDA has taken a number of steps to help applicants circumvent the high number of Refuse-to-Receive response. GDUFA II will introduce Pre-ANDA meetings to accelerate access to generics of complex products, including product development, pre‑submission, and mid‑review‑cycle meetings. The goal of the Pre‑ANDA Program in GDUFA II is to reduce the number of review cycles necessary to obtain ANDA approval of complex generics products. Pre‑ANDA submission meetings are an important opportunity to discuss the strategy and format of the planned application, and provide an opportunity for the FDA to give advice that will enable efficient review and improve the chance of first cycle approval. In addition, these meetings will allow the FDA to share information with the internal ANDA review team in order to prepare for unique review issues.
Getting It Right, Early
Similar to 505(b)(2) products, complex generic products require innovation, creativity, and a multiple disciplinary approach in obtaining a successful path to approval. A successful, efficient complex generic drug product program can provide a high-value opportunity for a drug development company. Because of the similarities in 505(b)(2) Pre-NDA meetings and the new Pre-ANDA meetings, Camargo is ideally positioned to help develop and guide a successful, efficient complex generic drug product program and create a high-value opportunity for your drug development company. Camargo’s multidisciplinary team includes in-house regulatory experts, and PhD pharmacokinetic, CMC, and research scientists who can improve your chances of avoiding a Refuse-to-Receive Response and/or a complete response letter. We have 14 years of experience in evaluating, strategically positioning, and justifying the similarities of complex products to reference products for both NDA and ANDA applications.