Complex Generics News
Up-to-date information on FDA’s actions on complex generics
Generally, complex generics are products that have complex active ingredients, formulations, dosage forms, or routes of administration, or are complex drug-device combination products. Generics of complex brand name drugs (i.e., reference listed drugs) can be more difficult to develop. As such, a complex drug may be less likely to have an available generic.
To help patients access important medical treatments, FDA’s Center for Drug Evaluation and Research works to better understand the scientific issues impacting complex generic development and assessment. FDA shares these scientific insights publicly, further enabling generic drug applicants to develop complex products and helping to ensure that applicants have the necessary information to prepare complete submissions.
This page features news, information, and additional resources about FDA’s activities that support the development and approval of complex generic drugs.
Approvals
Every year, FDA approves or tentatively approves hundreds of generic drug applications, including dozens of complex generics. 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.
Events
Below is a list of recent and upcoming events regarding complex generics.
Upcoming
- May 2, 2023: SBIA Webinar: Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”
- May 10, 2023: FDA/CRCG Training: Drug-Device Combination Products 101: Identifying, Developing, and Evaluating Drug-Device Combination Products
- May 11 – 12, 2023: Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop
- May 15, 2023: SBIA Webinar: A Deep Dive: GDUFA III Scientific Meetings
- June 15, 2023: FDA/CRCG Workshop: Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generics
Recent
- April 12-13, 2023: FDA Generic Drugs Forum (GDF) 2023 Celebrating 10 Years of the GDF
- April 20-22, 2023: FDA/CRCG Workshop: Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products
- December 6, 2022: FDA/CRCG Workshop: Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned
- November 3, 2022: FDA/CRCG Workshop: Formulation Characterization and Cutaneous Pharmacokinetics to Facilitate Generic Topical Product Development
- October 27-28, 2022: FDA/CRCG Workshop: Best Practices for Utilizing Modeling Approaches to Support Generic Product Development
- September 20-21, 2022: Advancing Generic Drug Development: Translating Science to Approval
- June 29, 2022: FDA/CRCG: In Vitro Release Test (IVRT) and In Vitro/In Vivo Correlation (IVIVC) of Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products
- May 9-10, 2022: Generic Drug Science and Research Initiatives Workshop
Guidances
Guidance documents represent FDA's current thinking on a topic and may discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Below is a list of recently published guidances and other documents related to complex generics.
Product-specific guidances (PSGs) provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA.
- In February 2023, FDA published a new draft guidance, Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.
- In February 2023, FDA published a new batch of 30 draft PSGs. FDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which is updated each time FDA publishes a new batch of PSGs.
- In November 2022, FDA published a new batch of 49 draft PSGs. FDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which is updated each time FDA publishes a new batch of PSGs.
- In October 2022, FDA published three draft guidances providing general recommendations for physicochemical and structural (collectively, “Q3”) characterization tests, in vitro release test (IVRT) studies, and in vitro permeation test (IVPT) studies for topical generic drug products:
- Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs Draft Guidance
- In Vitro Release Test (IVRT) Studies for Topical Drug Products Submitted in ANDAs Draft Guidance
- In Vitro Permeation Test (IVPT) Studies for Topical Drug Products Submitted in ANDAs Draft Guidance
- In October 2022, FDA published the draft guidance for industry, “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence”. This guidance is intended to assist applicants who submit abbreviated new drug applications for topical dermatologic corticosteroid products and describes recommendations for in vivo studies to demonstrate the bioequivalence of topical corticosteroids.
- In October 2022, FDA published a revised final guidance for industry, “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA” This guidance, previously published in November 2020, describes the enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) an ANDA for a complex generic drug product to FDA.
- In August 2022, FDA published a new batch of 48 draft PpGs. PDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which is updated each time FDA publishes a new batch of PSGs.
Research-related Articles
FDA’s GDUFA Science and Research Program provides new tools for FDA to evaluate generic drug equivalence and for industry to efficiently develop new generic products. Below are recent FDA articles focusing on complex generics.
- Collaboration and Scientific Innovation Stimulated Advancement in the Generic Drug Program in 2022
- Establishing Quantitative Relationships Between Changes in Nasal Spray In Vitro Metrics and Drug Delivery to the Posterior Nasal Region
- FY22 GDUFA Science & Research Report
- Product Quality Research for Developing and Assessing Regulatory Submissions for Generic Cyclosporine Ophthalmic Emulsions
Additional Resources
Further information on complex generics is available at the links below.
- The Center for Research on Complex Generics
- Product-Specific Guidances for Generic Drug Development
- Upcoming Product-Specific Guidances for Complex Generic Drug Product Development
- GDUFA Science and Research
- Generic Drug Research Priorities and Projects
- FDA Drug Competition Action Plan
- Infographic GDUFA III – Summary of T-Cons and Meetings (PDF - 117 KB)