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.

White Paper: Addressing Barriers to the Development of Complex Generics

As the number of complex brand-name, or innovator, products on the market has increased, the scientific and regulatory process and pathways for development and approval of generic versions of these drugs and drug products, commonly referred to as complex generics, may not be as well-established as with innovator drug products.

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Complex Generics Medicines
Complex generics: The need and the challenges

What are complex generics, what is the need for them, and why are they challenging to bring to market?

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Woman getting medicine through an IV
Proposals for the Development, Composition, and Routine Use of System Suitability Standard Mixtures in Support of Chromatographic Screening for Organic Extractables and Leachables

Leachables present in packaged drug products or released from medical devices can adversely affect patient health and safety.

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Man holding a pill organizer and medicine
Complex generics: Are global regulators addressing the needs?

The development of generic versions of innovator medicines is a global public health need. When it comes to complex generics, global regulators and standard-setting organizations can help address related challenges.

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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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