A General Guide to GDUFA III and Complex Generics

GDUFA III

GDUFA III stands for Generic Drug User Fee Amendments III. GDUFA was reauthorized on September 30, 2022 (GDUFA III) with provisions that are in effect from October 1, 2022, through September 30, 2027.

The goals of GDUFA III are to:

  1. Increase the predictability and timeliness of generic drug approvals 
  2. Improve the quality and safety of generic drugs 
  3. Reduce the cost of generic drugs 

GDUFA III includes a number of new provisions that are designed to achieve these goals, including:

  • A new goal date for the FDA to complete the review of generic drug applications
  • New performance standards for the FDA’s generic drug review program
  • New initiatives to improve the quality and safety of generic drugs
  • New measures to reduce the cost of generic drugs

The FDA and the generic drug industry are committed to working together to implement GDUFA III and achieve its goals. The agreement is a significant step forward in ensuring that patients have access to safe, high-quality, and affordable generic drugs.

Here are some of the key provisions of GDUFA III:

  • Timeliness: The FDA is required to complete the review of generic drug applications within 150 days, with the possibility of an additional 90-day extension.
  • Quality: The FDA is required to implement a number of new initiatives to improve the quality and safety of generic drugs, including enhanced risk-based inspections and increased oversight of contract manufacturing organizations.
  • Affordability: The FDA is required to take steps to reduce the cost of generic drugs, such as promoting competition and encouraging the development of new generic drugs.

GDUFA III is a significant improvement over the previous agreement, and it is expected to have a positive impact on the availability, quality, and affordability of generic drugs in the United States.

The key changes of GDUFA III compared to GDUFA II were expected to include:

  1. Fee Structure: GDUFA III was likely to introduce a revised fee structure for generic drug manufacturers. The specific fee amounts and payment schedules were subject to negotiation between the U.S. Food and Drug Administration (FDA) and industry stakeholders.
  2. Review Performance Goals: GDUFA III would set new performance goals for the FDA to review generic drug applications within specific timeframes. These goals aim to expedite the approval process and increase the efficiency of generic drug review.
  3. Enhanced Communications: GDUFA III might include provisions to facilitate more frequent and meaningful communication between the FDA and generic drug applicants to address any challenges or questions during the review process.
  4. Enhanced Surveillance and Inspection: The program was likely to focus on strengthening the FDA’s surveillance and inspection efforts to ensure the safety and quality of generic drug manufacturing facilities.
  5. Focus on Complex Products: GDUFA III could include specific measures to address the review and approval of complex generic drugs, such as those with delivery systems or formulations that present unique challenges.
  6. Measures to Encourage Innovation: The program might introduce incentives or pathways to encourage generic drug manufacturers to develop and submit applications for products in areas with limited competition or for drugs with public health significance.
  7. Regulatory Science Initiatives: GDUFA III may promote regulatory science initiatives to advance the development and evaluation of generic drug products, particularly in emerging technologies and complex formulations.
  8. Transparency and Public Reporting: The program might include provisions for increased transparency and public reporting of generic drug application review metrics and outcomes.

Complex Generics

Complex generics are a type of generic drug that is more difficult to develop and manufacture than a simple generic drug. Complex generics often have complex active ingredients, formulations, dosage forms, or routes of administration. They may also be drug-device combination products.

As per the FDA’s website, a complex generic drug product generally means the following:

  • A product with:
    • a complex active ingredient(s) (e.g., peptides, polymeric compounds, complex mixtures of APIs, naturally sourced ingredients)
    • a complex formulation (e.g., liposomes, colloids)
    • a complex route 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)
    • a complex dosage form (e.g., transdermals, metered dose inhalers, extended release injectables)
  • Complex drug-device combination products (e.g., auto injectors, metered dose inhalers)
  • Other products where complexity or uncertainty concerning the approval pathway or possible alternative approaches would benefit from early scientific engagement. 

The development and manufacture of complex generics can be more challenging than that of simple generics for a number of reasons. Complex generics may require the use of new technologies or manufacturing processes. They may also require more extensive testing and clinical trials.

As a result of these challenges, complex generics can take longer to develop and bring to market than simple generics. They may also be more expensive to manufacture.

Despite these challenges, the development and manufacture of complex generics is important. Complex generics can help to make safe and effective medications more affordable and accessible to patients.

Here are some examples of complex generics:

  • Injectable drugs: Injectable drugs are more difficult to develop and manufacture than oral drugs because they must be sterile and free of contaminants.
  • Biosimilars: Biosimilars are similar to biologic drugs, which are made from living organisms. Biosimilars must be shown to be safe and effective, but they do not have to be identical to the biologic drug they are based on.
  • Drug-device combination products: Drug-device combination products are products that combine a drug with a device, such as an inhaler or a patch. These products can be more difficult to develop and manufacture than drugs that are not combined with devices.

The development and manufacture of complex generics is a complex and challenging process. However, it is an important process that can help to make safe and effective medications more affordable and accessible to patients.

Below is a list of recent notable complex generic approvals:

  • On March 15, 2022, FDA approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol.
  • On February 24, 2022, FDA approved the first generic of Apokyn (apomorphine hydrochloride (HCl)) injection, 30 milligram (mg)/3 milliliter (mL) (10 mg/mL).
  • On February 2, 2022, FDA approved the first generic of Restasis (cyclosporine ophthalmic emulsion) 0.05% single-use vials.

 

Here are the examples of a few sterile complex generic products:

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Here are the examples of a few sterile and non-sterile complex generic products:

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WiTii Consulting is a Global Pharmaceutical Consulting firm that provides high-quality consulting services to pharmaceutical companies. We specialize in Drug Development and CMC services related to Generics, Compex Generics and 505(b)(2). Contact us below to discuss how WiTii Consulting can collaborate with your pharmaceutical company to achieve unparalleled success in Drug Development and CMC.

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