Complex generic drugs face unique scientific and regulatory hurdles that make FDA approval far harder than for simple generics. From liposomal injections to inhalers, these drugs require advanced testing, costly development, and evolving guidelines-delaying affordable access for patients.
Bioequivalence for inhalers, patches, and injections requires more than blood tests-it demands matching device performance, particle size, and delivery mechanics. Learn how regulators ensure generic versions truly work the same.
The FDA requires generic drugs to meet the same safety, strength, and effectiveness standards as brand name drugs. Through bioequivalence testing and strict manufacturing rules, generics are proven to work just as well-saving billions without compromising safety.
