FDA Defines Complex and Non-Complex Drugs for Generics Development
(Thursday, April 14, 2022)
Companies developing generic versions of complex drugs are eligible for enhanced support from the Office of Generic Drugs (OGD), mainly via pre-submission meetings under Generic Drugs User Fee Act (GDUFA) with the OGD reviewers to discuss bioequivalence testing requirements. However, FDA’s process for defining a complex drug was not very clear, till now. This week FDA published an internal standard process describing how it would determine a given drug to be a complex or non-complex product. An FDA approved new drug would be classified as a complex drug if it meets any of the five defining features. First, it has a complex active ingredient which is a combination of different components such as heparin, complex oils, botanical drug products, synthetic polymers, peptides, or oligonucleotides. Second, it has a complex route of delivery for example those requiring local administration such as patches and metered-dose pumps. Third criterion is drugs that have complex dosage form or formulation such as liposomal drugs, long-acting polymeric microspheres, semisolid dosage forms, nanosuspensions, nanotubes, nano-emulsions, long-acting injectable products, and iron complex formulations. The fourth kind of complex drugs are that those that are combination products regulated as drugs such as drug-device or drug-biologic combinations, co-packaged products, or cross-labeled combination products. These include pre-filled syringes, auto-injector products, inhaled products, transdermal or topical delivery products, IUDs, vaginal systems, and electronically tracked drugs. The fifth criterion are products that do not meet either of the previous four criteria but has uncertainty or complexity that may benefit from FDA discussions, in the opinion of the FDA. These include abuse-deterrent formulations, and miscellaneous formulations, to be classified as complex drugs on a case-by-case basis. The classification of the new approved drugs will be done by a Working Group composed of subject matter experts, and project managers with the OGD who may include personnel from other offices in FDA to review and guide the classification process. There is no timeline defined in the Manual of Policies and Procedures for completing the classification of the new drug but one can assume it would be completed in a timely fashion to aid the timely development of generics. Unlike non-complex drugs, generics for complex drugs are harder to create and present unique situations that require discussions with the OGD staff. Once a drug is classified as complex, the enhanced OGD support for its developers would become available automatically which should encourage generic developers for those products to approach FDA, and for FDA to write new guidance documents for those products.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC