Complex Generics

Generic medicines are essential to improving patient access to important drug therapies. They account for approximately 90% of prescriptions filled in the United States, contribute to lower prescription drug costs and help save trillions of dollars. For some patients, the availability of generics may determine whether they can access and afford treatment.

Complex generics are a growing category of products that are characterized by complex active ingredients, formulations or routes of delivery. Examples include inhalers, injectables, ophthalmic solutions and suspensions and transdermal patches. Patients rely on complex generic drug products for many indications, including chronic conditions such as diabetes and asthma.

Due to their complexity, generic versions of these drug products can be difficult to develop, so they are less likely to be available than other generics. These products also may be significantly more prone to drug shortages from supply, demand and regulatory issues. For patients, that can mean less access to medicines they need. USP is working with stakeholders across the medicines supply chain to understand the scientific and regulatory issues associated with complex generics to reduce barriers to their development and assessment, making them more accessible to the patients who need them.

extractables and leachables

Safeguarding Drug Quality: Importance of E&L Identification in Complex Generics

The identification of extractables and leachables (E&Ls) in complex generic drugs is crucial. Utilizing USP E&L solutions empowers pharmaceutical manufacturers to accurately identify and establish safety limits for E&Ls, fostering confidence in product quality and regulatory compliance.

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Robust LG polymer Solutions for CGx

Want comprehensive LG polymer characterization solutions for complex generics (CGx)?

complex generics inhaler

White Paper

Addressing Barriers to the Development of Complex Generics

Complex Generics Medicines

Blog

Complex generics: The need and the challenges.

Woman getting medicine through an IV

Stimuli Article

Proposals for the Development, Composition, and Routine Use of System Suitability Standard Mixtures in Support of Chromatographic Screening for Organic Extractables and Leachables

 

FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards
FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards

FDA's Draft Guidance for Topical Ophthalmic Drug Products: USP Standards

The FDA has issued warnings to consumers to stop using 29 over-the-counter (OTC) eye drops due to potential risk for eye infections that could result in partial vision loss or blindness.

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